AnesthesiaPEEPNCT05386901
The Effects of Individualized Lung-protective Ventilation With Lung Dynamic Compliance-guided Positive End-expiratory Pressure(PEEP) Titration on Postoperative Pulmonary Complications of Pediatric Video-assisted Thoracoscopic Surgery
A study testing Conventional positive end-expiratory pressure(PEEP) and Lung dynamic compliance guided positive end-expiratory pressure(PEEP) in people with Anesthesia and Surgery, run by Jiaxiang Chen at 1 site in China.
Trial summary
This study evaluates the influence of individualized lung-protective ventilation strategy(LPVS) on postoperative pulmonary complications(PPCs) through a randomized controlled trial when children undergoing thoracoscopic surgery with one-lung ventilation(OLV).The investigators evaluate the impact of using lung dynamic… Read more about this study
- Who is it for?
- Ages 1 month to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Anesthesia, Surgery
- What is being tested?
- Conventional positive end-expiratory pressure(PEEP) and Lung dynamic compliance guided positive end-expiratory pressure(PEEP)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteChina
- Study dates
- 10 Jun 2022to 1 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children undergoing elective thoracoscopic pulmonary surgery.
- Written informed consent.
- Children under 5 years old (including 5 years old)
- ASA classification 1-2
- Respiratory Risk Assessment in Catalan Surgical Patients (ARISCAT) Criteria Low or Moderate Risk
Who cannot join
- Symptoms of upper respiratory tract infection or pulmonary infection in the past 4 weeks, chest X-ray suggests pneumonia
- Severe circulatory disease
- Children with bullae
- Intraoperative arterial blood pressure monitoring cannot be performed
- Respiratory Risk Assessment in Catalan Surgical Patients (ARISCAT) Criteria Rated High Risk
Trial locations and contacts
1 site in 1 country.
About this study
This study evaluates the influence of individualized lung-protective ventilation strategy(LPVS) on postoperative pulmonary complications(PPCs) through a randomized controlled trial when children undergoing thoracoscopic surgery with one-lung ventilation(OLV).The investigators evaluate the impact of using lung dynamic compliance-guided Positive End-expiratory Pressure(PEEP) versus conventional PEEP on a pressure-controlled ventilation(PCV).The researchers also analyzed perioperative vital signs and respiratory indicators of these LPVS.
Read the detailed description
With the advancement of pediatric thoracic surgery techniques, the age group of children who can receive thoracoscopic surgery is getting younger and younger, and even neonates can accept it. In thoracic surgery, the incidence of PPCs is as high as 30%-50%, which is one of the main reasons for poor prognosis, increased mortality and prolonged hospitalization. In recent years, more and more studies have shown that the perioperative implementation of appropriate LPVS can reduce the occurrence of PPCs. How to optimize the lung protection strategy in pediatric thoracic surgery has become one of the key issues of perioperative medical attention, and there is no consensus in clinical application.
LPVS is one of the important components of lung protection strategies, including low tidal volume, PEEP and lung recruitment strategies.How to choose the most suitable PEEP is an important part in the implementation of LPVS. The optimal PEEP value should be the corresponding pressure value when the compliance between alveolar opening and over-inflation is the best. In recent years, many scholars have studied PEEP titration methods, such as lung dynamic compliance-guided PEEP, pressure-volume (P-V) curve-guided PEEP, transpulmonary pressure-guided PEEP, and electrical impedance tomography (EIT)-guided PEEP and so on.However, there are no published studies addressing the effects of lung dynamic compliance-guided PEEP on PPCs and perioperative vital signs and respiratory indicators of pediatric surgical patients when associated with OLA strategies for ventilation.
This study is a randomized controlled trial. After meeting the inclusion conditions, the researchers were assigned to any of the two groups of lung dynamic compliance-guided individualized PEEP and conventional PEEP. The clinical anesthesia and mechanical ventilation parameter settings and data statistical analysis were completed by different anesthesiologists and participants.
On the day of surgery, standard monitoring was initiated on arrival in the theatre, including electrocardiography, pulse oximetry, and noninvasive blood pressure monitoring.Both groups were given routine standard anesthesia induction: intravenous injection of midazolam at 0.05-0.1 mg/kg of predicted body weight (PBW), propofol at 2-4 mg/kg of PBW, and intravenous injection of Sufentanil at 0.3-0.5 ug/kg of PBW, rocuronium at 0.5-1mg/kg of PBW.After adequate pre-oxygenation, endotracheal intubation and bronchial occluder placement under video laryngoscope, using fiberoptic bronchoscopy and auscultation make sure the occluder is properly positioned. The investigators will adjust breathing parameters after starting double-lung ventilation,which is a pressure control mode(PCV) using an airway pressure of 20-25mmHg with tidal volume not exceeding 6ml/kg of PBW and an inspiration: expiration ratio of 1:2;a respiratory rate of 20-40 breaths per minute to keep PaCO2 < 60 mmHg as well as FiO2 of 50% and flow of 3L/min.Then, the first lung recruitment strategy was started. The manual lung recruitment method was used, and the ventilation mode was manually controlled. The APL valve was adjusted to 30cmH2O, maintained for 15-20 seconds, and then returned to the machine-controlled ventilation mode. Arterial puncture and catheterization were performed to establish an invasive arterial monitoring channel. Intraoperative maintenance medication: 2%-3% sevoflurane, dexmedetomidine (0.1-0.2ug/kg.h of PBW), sufentanil and rocuronium bromide were added in stages according to intraoperative conditions to maintain sufficient doses above sedative analgesia and muscle relaxation.
Before starting OLV, pure oxygen hyperventilation was used, FiO2 was adjusted to 100%, and the maintenance time was not less than 3 minutes to increase the oxygen concentration in both lungs and improve the tolerance of children to hypoxia and the success rate of lung collapse. After switching to OLV, a second manual recruitment strategy was performed. The PEEP settings were divided into two groups: the canventional lung protective ventilation experimental group held PEEP at 5 cmH2O, the pulmonary dynamic compliance guided PEEP group passed increasing PEEP (0-14 cmH2O), and the lung dynamic compliance = Vt/(Pplat-PEEP).The initial PEEP is set to 0cmH2O, which is increased by 2 cmH2O every 2 minutes. Observe the PEEP value corresponding to the maximum lung dynamic compliance during the process. After the incremental PEEP process is completed, setting the PEEP value for ventilation until the end of the operation.
At the end of one-lung ventilation, a third manual recruitment maneuver was performed before switching to double-lung ventilation. After the operation, the patients were sent to the ICU with a tracheal catheters or sent to the PACU before extubation according to the condition of the child.
All data were collected, aggregated and maintained by a single investigator. Including preoperative demographic data, ARISCAT score data, surgery-related data, anesthesia-related data, intraoperative general vital signs and respiratory indicators, postoperative PPCs-related data, postoperative medication, other postoperative complications, hospital stay, ICU Hospitalization time, respiratory support time, hospitalization time, biochemical indicators during hospitalization, inflammatory indicators, electrolytes, cardiac function indicators, etc.
This study was a superiority test, so a one-sided test was used, and the first-class error (α) was set to 0.05, and the second-class error (β) was set to 0.2 (that is, the power of 1-β was set to 0.8). The main observation index of this study is the incidence of PPCs. According to the literature review, the incidence of PPCs in the two groups in similar studies was 11% and 39%, respectively. In PASS 15.0, "Test for Two Proportions" was selected for calculation. The dropout rate is set to 10%, and the calculation result is that each group needs 30 patients.It would be necessary to recruit 60 patients in the study.
The full analysis set was used for analysis. According to the basic principle of Intention-to-Treat (ITT), the analysis of the main indicators includes all randomized subjects, regardless of whether they completed the trial or not, that is, subjects who were lost to follow-up should also be included in the statistical analysis. Statistical software SPSS 26.0 was used for data processing and statistical analysis. Shapiro-Wilk test was first performed on the data, and continuous variable data (such as blood pressure, heart rate, driving pressure, oxygenation index, etc.) were determined to use t test or Mann-Whitney U test according to their normal distribution. Categorical variables (such as age, incidence of PPCs, etc.) were tested by χ² test, Fisher's exact test, and the results were expressed as mean ± standard deviation (SD), percentage (%) or median (interquartile range, IQR), P <0.05 is statistically significant.
- Conditions
- Anesthesia, Surgery
- Being tested
- Conventional positive end-expiratory pressure(PEEP), Lung dynamic compliance guided positive end-expiratory pressure(PEEP)
- Keywords
- Lung dynamic compliance, Positive end-expiratory pressure(PEEP), One-lung ventilation(OLV), Lung protection strategy, Postoperative pulmonary complications(PPCs)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional positive end-expiratory pressure(PEEP)Procedure or surgery
Positive end-expiratory pressure is the mechanical ventilator that generates positive pressure during the inspiratory phase to pass gas into the lungs. When the airway opens at the end of expiration, the airway pressure remains above atmospheric pressure to prevent the alveoli from shrinking and collapsing.In this intervention arm It will be set to 5 cmH2O until the end of the operation.
Lung dynamic compliance guided positive end-expiratory pressure(PEEP)Procedure or surgery
Positive end-expiratory pressure is the mechanical ventilator that generates positive pressure during the inspiratory phase to pass gas into the lungs. When the airway opens at the end of expiration, the airway pressure remains above atmospheric pressure to prevent the alveoli from shrinking and collapsing.In this intervention arm It will be set to individual value until the end of the operation.The individualized values are obtained by observing the maximum Lung dynamic compliance during PEEP titration.
| Study group | Role | What they receive |
|---|---|---|
| Conventional positive end-expiratory pressure(PEEP) | Experimental | Once the patient is intubated and after initiating ventilation in a pressure control mode(PCV) using an airway pressure of 20-25mmHg with tidal volume not exceeding 6ml/kg of predicted body weight (PBW) and an inspiration: expiration ratio of 1:2;a respiratory rate of 20-30 breaths per minute to maintain the etCO2 at 35-40 mmHg.The investigators will set the PEEP value to 5 cmH2O until the end of the operation. Receives: Procedure: Conventional positive end-expiratory pressure(PEEP) |
| Lung dynamic compliance guided positive end-expiratory pressure(PEEP) | Experimental | Once the patient is intubated and after initiating ventilation in a pressure control mode(PCV) using an airway pressure of 20-25mmHg with tidal volume not exceeding 6ml/kg of predicted body weight (PBW) and an inspiration: expiration ratio of 1:2;a respiratory rate of 20-30 breaths per minute to maintain the etCO2 at 35-40 mmHg.The investigators will set initial PEEP to 0cmH2O,and the PEEP is increased by 2 cmH2O every 2 minutes.Observing the PEEP value corresponding to the maximum lung dynamic compliance during the process that lung dynamic compliance=Vt/(Pplat-PEEP).After the incremental PEEP process is completed, setting the PEEP value for ventilation until the end of the operation. Receives: Procedure: Lung dynamic compliance guided positive end-expiratory pressure(PEEP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pulmonary complication(PPCs) rate at 7 days
PPCs are classified into 5 grades according to Postoperative pulmonary complications score fo JAMA.
Grade 1:Cough, dry.Microatelectasis.Dyspnea, not due to other documented cause
Grade 2:Cough, productive, not due to other documented cause.Bronchospasm.Hypoxemia (SpO2 ≤ 90%) at room air.Atelectasis.Hypercarbia (PaCO2 > 50 mmHg), requiring treatment
Grade 3:Pleural effusion, resulting in thoracentesis.Pneumonia.Pneumothorax.Noninvasive ventilation, strictly applied to those with all of the following: a) oxygen saturation(SpO2)lower than 92% under supplemental oxygen; b) need of supplemental oxygen >5 L/min; and RR ≥ 30 bpm .Re-intubation postoperative or intubation, period of ventilator dependence (non-invasive or invasive ventilation) ≤ 48 hours
Grade 4:Ventilatory failure: postoperative ventilator dependence exceeding 48 hours, or reintubation with subsequent period of ventilator dependence exceeding 48 hours
Grade 5:Death before hospital discharge
Measured: 7 days after surgery
Secondary outcomes (4)
Oxygenation Index
Arterial partial pressure of oxygen divided by inspired oxygen concentration(PaO2/FiO2).
Measured: 5 minutes after tracheal intubation (T1), 5 minutes after OLV (T2), 1 hour after OLV (T3-1), 2 hours after OLV (T3-2), 3 hours after OLV (T3-3), 4 hours after one-lung ventilation (T3-4), 5 minutes after the end of surgery (T4)
Driving pressure
Driving pressure = Pplateau -PEEP
Measured: 5 minutes after tracheal intubation (T1), 5 minutes after OLV (T2), 1 hour after OLV (T3-1), 2 hours after OLV (T3-2), 3 hours after OLV (T3-3), 4 hours after one-lung ventilation (T3-4), 5 minutes after the end of surgery (T4)
Lung dynamic compliance
LCdyn = TV/(Pplat-PEEP)
Measured: 5 minutes after tracheal intubation (T1), 5 minutes after OLV (T2), 1 hour after OLV (T3-1), 2 hours after OLV (T3-2), 3 hours after OLV (T3-3), 4 hours after one-lung ventilation (T3-4),5 minutes after the end of surgery (T4)
Modified lung ultrasound score
The score is calculated by adding up the 12 individual quadrant scores assessed using lung ultrasound.
Measured: Postoperative 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2022
- Study start10 Jun 2022
- Primary completion1 Jun 2024
- Study completion1 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients were randomly assigned to lung dynamic compliance-guided individualized PEEP group and traditional PEEP group.The traditional lung protective ventilation experimental group kept PEEP at 5cmH2O, and the lung dynamic compliance-oriented individualized PEEP group passed the incremental PEEP (0-14cmH2O). lung dynamic compliance==Vt/(Pplat-PEEP).The initial PEEP is set to 0cmH2O, and the PEEP is increased by 2cmH2O every 2 minutes. Observe the PEEP value corresponding to the maximum lung dynamic compliance during the process. After the incremental PEEP process is completed, set the PEEP value for ventilation until the end of the operation.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiaxiang Chen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jiaxiang Chen, Shantou University Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05386901
- Sponsor's protocol ID
- 13229547507
- Acronym
- PEEP
- Status last verified
- Jun 2026
- First submitted
- 17 May 2022
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All of the individual participant data collected during the trial, after deidentification.
Publications
Costa Leme A, Hajjar LA, Volpe MS, Fukushima JT, De Santis Santiago RR, Osawa EA, Pinheiro de Almeida J, Gerent AM, Franco RA, Zanetti Feltrim MI, Nozawa E, de Moraes Coimbra VR, de Moraes Ianotti R, Hashizume CS, Kalil Filho R, Auler JO Jr, Jatene FB, Gomes Galas FR, Amato MB. Effect of Intensive vs Moderate Alveolar Recruitment Strategies Added to Lung-Protective Ventilation on Postoperative Pulmonary Complications: A Randomized Clinical Trial. JAMA. 2017 Apr 11;317(14):1422-1432. doi: 10.1001/jama.2017.2297.
PubMed 28322416Templeton TW, Miller SA, Lee LK, Kheterpal S, Mathis MR, Goenaga-Diaz EJ, Templeton LB, Saha AK; Multicenter Perioperative Outcomes Group Investigators. Hypoxemia in Young Children Undergoing One-lung Ventilation: A Retrospective Cohort Study. Anesthesiology. 2021 Nov 1;135(5):842-853. doi: 10.1097/ALN.0000000000003971.
PubMed 34543405Chandler D, Mosieri C, Kallurkar A, Pham AD, Okada LK, Kaye RJ, Cornett EM, Fox CJ, Urman RD, Kaye AD. Perioperative strategies for the reduction of postoperative pulmonary complications. Best Pract Res Clin Anaesthesiol. 2020 Jun;34(2):153-166. doi: 10.1016/j.bpa.2020.04.011. Epub 2020 Apr 23.
PubMed 32711826iPROVE Network investigators; Belda J, Ferrando C, Garutti I. The Effects of an Open-Lung Approach During One-Lung Ventilation on Postoperative Pulmonary Complications and Driving Pressure: A Descriptive, Multicenter National Study. J Cardiothorac Vasc Anesth. 2018 Dec;32(6):2665-2672. doi: 10.1053/j.jvca.2018.03.028. Epub 2018 Mar 27.
PubMed 29709437Lee JH, Ji SH, Lee HC, Jang YE, Kim EH, Kim HS, Kim JT. Evaluation of the intratidal compliance profile at different PEEP levels in children with healthy lungs: a prospective, crossover study. Br J Anaesth. 2020 Nov;125(5):818-825. doi: 10.1016/j.bja.2020.06.046. Epub 2020 Jul 15.
PubMed 32682552Xu D, Wei W, Chen L, Li S, Lian M. Effects of different positive end-expiratory pressure titrating strategies on oxygenation and respiratory mechanics during one- lung ventilation: a randomized controlled trial. Ann Palliat Med. 2021 Feb;10(2):1133-1144. doi: 10.21037/apm-19-441. Epub 2020 Sep 15.
PubMed 32954753Zhou ZF, Fang JB, Wang HF, He Y, Yu YJ, Xu Q, Ge YF, Zhang MZ, Hu SF. Effects of intraoperative PEEP on postoperative pulmonary complications in high-risk patients undergoing laparoscopic abdominal surgery: study protocol for a randomised controlled trial. BMJ Open. 2019 Oct 30;9(10):e028464. doi: 10.1136/bmjopen-2018-028464.
PubMed 31672709Lee JH, Bae JI, Jang YE, Kim EH, Kim HS, Kim JT. Lung protective ventilation during pulmonary resection in children: a prospective, single-centre, randomised controlled trial. Br J Anaesth. 2019 May;122(5):692-701. doi: 10.1016/j.bja.2019.02.013. Epub 2019 Mar 8.
PubMed 30916035Beitler JR, Sarge T, Banner-Goodspeed VM, Gong MN, Cook D, Novack V, Loring SH, Talmor D; EPVent-2 Study Group. Effect of Titrating Positive End-Expiratory Pressure (PEEP) With an Esophageal Pressure-Guided Strategy vs an Empirical High PEEP-Fio2 Strategy on Death and Days Free From Mechanical Ventilation Among Patients With Acute Respiratory Distress Syndrome: A Randomized Clinical Trial. JAMA. 2019 Mar 5;321(9):846-857. doi: 10.1001/jama.2019.0555.
PubMed 30776290Writing Group for the Alveolar Recruitment for Acute Respiratory Distress Syndrome Trial (ART) Investigators; Cavalcanti AB, Suzumura EA, Laranjeira LN, Paisani DM, Damiani LP, Guimaraes HP, Romano ER, Regenga MM, Taniguchi LNT, Teixeira C, Pinheiro de Oliveira R, Machado FR, Diaz-Quijano FA, Filho MSA, Maia IS, Caser EB, Filho WO, Borges MC, Martins PA, Matsui M, Ospina-Tascon GA, Giancursi TS, Giraldo-Ramirez ND, Vieira SRR, Assef MDGPL, Hasan MS, Szczeklik W, Rios F, Amato MBP, Berwanger O, Ribeiro de Carvalho CR. Effect of Lung Recruitment and Titrated Positive End-Expiratory Pressure (PEEP) vs Low PEEP on Mortality in Patients With Acute Respiratory Distress Syndrome: A Randomized Clinical Trial. JAMA. 2017 Oct 10;318(14):1335-1345. doi: 10.1001/jama.2017.14171.
PubMed 28973363Mazo V, Sabate S, Canet J, Gallart L, de Abreu MG, Belda J, Langeron O, Hoeft A, Pelosi P. Prospective external validation of a predictive score for postoperative pulmonary complications. Anesthesiology. 2014 Aug;121(2):219-31. doi: 10.1097/ALN.0000000000000334.
PubMed 24901240Pereira SM, Tucci MR, Morais CCA, Simoes CM, Tonelotto BFF, Pompeo MS, Kay FU, Pelosi P, Vieira JE, Amato MBP. Individual Positive End-expiratory Pressure Settings Optimize Intraoperative Mechanical Ventilation and Reduce Postoperative Atelectasis. Anesthesiology. 2018 Dec;129(6):1070-1081. doi: 10.1097/ALN.0000000000002435.
PubMed 30260897Chen J, Lin R, Shi X, Liang C, Hu W, Ma X, Xu L. Effects of individualised lung-protective ventilation with lung dynamic compliance-guided positive end-expiratory pressure titration on postoperative pulmonary complications of paediatric video-assisted thoracoscopic surgery: protocol for a randomised controlled trial. BMJ Paediatr Open. 2024 Jul 16;8(1):e002359. doi: 10.1136/bmjpo-2023-002359.
PubMed 39019541
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Individualized Lung-protective Ventilation With Lung Dynamic Compliance-guided Positive End-expiratory Pressure(PEEP) Titration on Postoperative Pulmonary Complications of Pediatric Video-assisted Thoracoscopic Surgery
- ClinicalTrials.gov ID
- NCT05386901
- Acronym / sponsor ID
- PEEP / 13229547507
- Conditions
- Anesthesia, Surgery
- Keywords
- Lung dynamic compliance, Positive end-expiratory pressure(PEEP), One-lung ventilation(OLV), Lung protection strategy, Postoperative pulmonary complications(PPCs)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Jiaxiang ChenUniversity, hospital or other
- Study start
- 10 Jun 2022 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 1 Oct 2024 (actual)
- First posted
- 23 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the influence of individualized lung-protective ventilation strategy(LPVS) on postoperative pulmonary complications(PPCs) through a randomized controlled trial when children undergoing thoracoscopic surgery with one-lung ventilation(OLV).The investigators evaluate the impact of using lung dynamic compliance-guided Positive End-expiratory Pressure(PEEP) versus conventional PEEP on a pressure-controlled ventilation(PCV).The researchers also analyzed perioperative vital signs and respiratory indicators of these LPVS.
Detailed description
With the advancement of pediatric thoracic surgery techniques, the age group of children who can receive thoracoscopic surgery is getting younger and younger, and even neonates can accept it. In thoracic surgery, the incidence of PPCs is as high as 30%-50%, which is one of the main reasons for poor prognosis, increased mortality and prolonged hospitalization. In recent years, more and more studies have shown that the perioperative implementation of appropriate LPVS can reduce the occurrence of PPCs. How to optimize the lung protection strategy in pediatric thoracic surgery has become one of the key issues of perioperative medical attention, and there is no consensus in clinical application.
LPVS is one of the important components of lung protection strategies, including low tidal volume, PEEP and lung recruitment strategies.How to choose the most suitable PEEP is an important part in the implementation of LPVS. The optimal PEEP value should be the corresponding pressure value when the compliance between alveolar opening and over-inflation is the best. In recent years, many scholars have studied PEEP titration methods, such as lung dynamic compliance-guided PEEP, pressure-volume (P-V) curve-guided PEEP, transpulmonary pressure-guided PEEP, and electrical impedance tomography (EIT)-guided PEEP and so on.However, there are no published studies addressing the effects of lung dynamic compliance-guided PEEP on PPCs and perioperative vital signs and respiratory indicators of pediatric surgical patients when associated with OLA strategies for ventilation.
This study is a randomized controlled trial. After meeting the inclusion conditions, the researchers were assigned to any of the two groups of lung dynamic compliance-guided individualized PEEP and conventional PEEP. The clinical anesthesia and mechanical ventilation parameter settings and data statistical analysis were completed by different anesthesiologists and participants.
On the day of surgery, standard monitoring was initiated on arrival in the theatre, including electrocardiography, pulse oximetry, and noninvasive blood pressure monitoring.Both groups were given routine standard anesthesia induction: intravenous injection of midazolam at 0.05-0.1 mg/kg of predicted body weight (PBW), propofol at 2-4 mg/kg of PBW, and intravenous injection of Sufentanil at 0.3-0.5 ug/kg of PBW, rocuronium at 0.5-1mg/kg of PBW.After adequate pre-oxygenation, endotracheal intubation and bronchial occluder placement under video laryngoscope, using fiberoptic bronchoscopy and auscultation make sure the occluder is properly positioned. The investigators will adjust breathing parameters after starting double-lung ventilation,which is a pressure control mode(PCV) using an airway pressure of 20-25mmHg with tidal volume not exceeding 6ml/kg of PBW and an inspiration: expiration ratio of 1:2;a respiratory rate of 20-40 breaths per minute to keep PaCO2 < 60 mmHg as well as FiO2 of 50% and flow of 3L/min.Then, the first lung recruitment strategy was started. The manual lung recruitment method was used, and the ventilation mode was manually controlled. The APL valve was adjusted to 30cmH2O, maintained for 15-20 seconds, and then returned to the machine-controlled ventilation mode. Arterial puncture and catheterization were performed to establish an invasive arterial monitoring channel. Intraoperative maintenance medication: 2%-3% sevoflurane, dexmedetomidine (0.1-0.2ug/kg.h of PBW), sufentanil and rocuronium bromide were added in stages according to intraoperative conditions to maintain sufficient doses above sedative analgesia and muscle relaxation.
Before starting OLV, pure oxygen hyperventilation was used, FiO2 was adjusted to 100%, and the maintenance time was not less than 3 minutes to increase the oxygen concentration in both lungs and improve the tolerance of children to hypoxia and the success rate of lung collapse. After switching to OLV, a second manual recruitment strategy was performed. The PEEP settings were divided into two groups: the canventional lung protective ventilation experimental group held PEEP at 5 cmH2O, the pulmonary dynamic compliance guided PEEP group passed increasing PEEP (0-14 cmH2O), and the lung dynamic compliance = Vt/(Pplat-PEEP).The initial PEEP is set to 0cmH2O, which is increased by 2 cmH2O every 2 minutes. Observe the PEEP value corresponding to the maximum lung dynamic compliance during the process. After the incremental PEEP process is completed, setting the PEEP value for ventilation until the end of the operation.
At the end of one-lung ventilation, a third manual recruitment maneuver was performed before switching to double-lung ventilation. After the operation, the patients were sent to the ICU with a tracheal catheters or sent to the PACU before extubation according to the condition of the child.
All data were collected, aggregated and maintained by a single investigator. Including preoperative demographic data, ARISCAT score data, surgery-related data, anesthesia-related data, intraoperative general vital signs and respiratory indicators, postoperative PPCs-related data, postoperative medication, other postoperative complications, hospital stay, ICU Hospitalization time, respiratory support time, hospitalization time, biochemical indicators during hospitalization, inflammatory indicators, electrolytes, cardiac function indicators, etc.
This study was a superiority test, so a one-sided test was used, and the first-class error (α) was set to 0.05, and the second-class error (β) was set to 0.2 (that is, the power of 1-β was set to 0.8). The main observation index of this study is the incidence of PPCs. According to the literature review, the incidence of PPCs in the two groups in similar studies was 11% and 39%, respectively. In PASS 15.0, "Test for Two Proportions" was selected for calculation. The dropout rate is set to 10%, and the calculation result is that each group needs 30 patients.It would be necessary to recruit 60 patients in the study.
The full analysis set was used for analysis. According to the basic principle of Intention-to-Treat (ITT), the analysis of the main indicators includes all randomized subjects, regardless of whether they completed the trial or not, that is, subjects who were lost to follow-up should also be included in the statistical analysis. Statistical software SPSS 26.0 was used for data processing and statistical analysis. Shapiro-Wilk test was first performed on the data, and continuous variable data (such as blood pressure, heart rate, driving pressure, oxygenation index, etc.) were determined to use t test or Mann-Whitney U test according to their normal distribution. Categorical variables (such as age, incidence of PPCs, etc.) were tested by χ² test, Fisher's exact test, and the results were expressed as mean ± standard deviation (SD), percentage (%) or median (interquartile range, IQR), P <0.05 is statistically significant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Patients were randomly assigned to lung dynamic compliance-guided individualized PEEP group and traditional PEEP group.The traditional lung protective ventilation experimental group kept PEEP at 5cmH2O, and the lung dynamic compliance-oriented individualized PEEP group passed the incremental PEEP (0-14cmH2O). lung dynamic compliance==Vt/(Pplat-PEEP).The initial PEEP is set to 0cmH2O, and the PEEP is increased by 2cmH2O every 2 minutes. Observe the PEEP value corresponding to the maximum lung dynamic compliance during the process. After the incremental PEEP process is completed, set the PEEP value for ventilation until the end of the operation.
| Arm | Type | Receives |
|---|---|---|
| Conventional positive end-expiratory pressure(PEEP) | Experimental | Procedure: Conventional positive end-expiratory pressure(PEEP)Once the patient is intubated and after initiating ventilation in a pressure control mode(PCV) using an airway pressure of 20-25mmHg with tidal volume not exceeding 6ml/kg of predicted body weight (PBW) and an inspiration: expiration ratio of 1:2;a respiratory rate of 20-30 breaths per minute to maintain the etCO2 at 35-40 mmHg.The investigators will set the PEEP value to 5 cmH2O until the end of the operation. |
| Lung dynamic compliance guided positive end-expiratory pressure(PEEP) | Experimental | Procedure: Lung dynamic compliance guided positive end-expiratory pressure(PEEP)Once the patient is intubated and after initiating ventilation in a pressure control mode(PCV) using an airway pressure of 20-25mmHg with tidal volume not exceeding 6ml/kg of predicted body weight (PBW) and an inspiration: expiration ratio of 1:2;a respiratory rate of 20-30 breaths per minute to maintain the etCO2 at 35-40 mmHg.The investigators will set initial PEEP to 0cmH2O,and the PEEP is increased by 2 cmH2O every 2 minutes.Observing the PEEP value corresponding to the maximum lung dynamic compliance during the process that lung dynamic compliance=Vt/(Pplat-PEEP).After the incremental PEEP process is completed, setting the PEEP value for ventilation until the end of the operation. |
Who may qualify
- Ages
- 1 month to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Children undergoing elective thoracoscopic pulmonary surgery.
- Written informed consent.
- Children under 5 years old (including 5 years old)
- ASA classification 1-2
- Respiratory Risk Assessment in Catalan Surgical Patients (ARISCAT) Criteria Low or Moderate Risk
Key exclusion criteria (5 listed)
- Symptoms of upper respiratory tract infection or pulmonary infection in the past 4 weeks, chest X-ray suggests pneumonia
- Severe circulatory disease
- Children with bullae
- Intraoperative arterial blood pressure monitoring cannot be performed
- Respiratory Risk Assessment in Catalan Surgical Patients (ARISCAT) Criteria Rated High Risk
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional positive end-expiratory pressure(PEEP)Positive end-expiratory pressure is the mechanical ventilator that generates positive pressure during the inspiratory phase to pass gas into the lungs. When the airway opens at the end of expiration, the airway pressure remains above atmospheric pressure to prevent the alveoli from shrinking and collapsing.In this intervention arm It will be set to 5 cmH2O until the end of the operation. | Procedure or surgery | Conventional positive end-expiratory pressure(PEEP) |
| Lung dynamic compliance guided positive end-expiratory pressure(PEEP)Positive end-expiratory pressure is the mechanical ventilator that generates positive pressure during the inspiratory phase to pass gas into the lungs. When the airway opens at the end of expiration, the airway pressure remains above atmospheric pressure to prevent the alveoli from shrinking and collapsing.In this intervention arm It will be set to individual value until the end of the operation.The individualized values are obtained by observing the maximum Lung dynamic compliance during PEEP titration. | Procedure or surgery | Lung dynamic compliance guided positive end-expiratory pressure(PEEP) |
Primary outcome
Postoperative pulmonary complication(PPCs) rate at 7 days
Time frame: 7 days after surgery
PPCs are classified into 5 grades according to Postoperative pulmonary complications score fo JAMA. Grade 1:Cough, dry.Microatelectasis.Dyspnea, not due to other documented cause Grade 2:Cough, productive, not due to other documented cause.Bronchospasm.Hypoxemia (SpO2 ≤ 90%) at room air.Atelectasis.Hypercarbia (PaCO2 > 50 mmHg), requiring treatment Grade 3:Pleural effusion, resulting in thoracentesis.Pneumonia.Pneumothorax.Noninvasive ventilation, strictly applied to those with all of the following: a) oxygen saturation(SpO2)lower than 92% under supplemental oxygen; b) need of supplemental oxygen >5 L/min; and RR ≥ 30 bpm .Re-intubation postoperative or intubation, period of ventilator dependence (non-invasive or invasive ventilation) ≤ 48 hours Grade 4:Ventilatory failure: postoperative ventilator dependence exceeding 48 hours, or reintubation with subsequent period of ventilator dependence exceeding 48 hours Grade 5:Death before hospital discharge
4 secondary outcomes
Oxygenation Index
Time frame: 5 minutes after tracheal intubation (T1), 5 minutes after OLV (T2), 1 hour after OLV (T3-1), 2 hours after OLV (T3-2), 3 hours after OLV (T3-3), 4 hours after one-lung ventilation (T3-4), 5 minutes after the end of surgery (T4)
Driving pressure
Time frame: 5 minutes after tracheal intubation (T1), 5 minutes after OLV (T2), 1 hour after OLV (T3-1), 2 hours after OLV (T3-2), 3 hours after OLV (T3-3), 4 hours after one-lung ventilation (T3-4), 5 minutes after the end of surgery (T4)
Lung dynamic compliance
Time frame: 5 minutes after tracheal intubation (T1), 5 minutes after OLV (T2), 1 hour after OLV (T3-1), 2 hours after OLV (T3-2), 3 hours after OLV (T3-3), 4 hours after one-lung ventilation (T3-4),5 minutes after the end of surgery (T4)
Modified lung ultrasound score
Time frame: Postoperative 1 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
- Results publication: PubMed 28322416Costa Leme A, Hajjar LA, Volpe MS, Fukushima JT, De Santis Santiago RR, Osawa EA, Pinheiro de Almeida J, Gerent AM, Franco RA, Zanetti Feltrim MI, Nozawa E, de Moraes Coimbra VR, de Moraes Ianotti R, Hashizume CS, Kalil Filho R, Auler JO Jr, Jatene FB, Gomes Galas FR, Amato MB. Effect of Intensive vs Moderate Alveolar Recruitment Strategies Added to Lung-Protective Ventilation on Postoperative Pulmonary Complications: A Randomized Clinical Trial. JAMA. 2017 Apr 11;317(14):1422-1432. doi: 10.1001/jama.2017.2297.
- Results publication: PubMed 34543405Templeton TW, Miller SA, Lee LK, Kheterpal S, Mathis MR, Goenaga-Diaz EJ, Templeton LB, Saha AK; Multicenter Perioperative Outcomes Group Investigators. Hypoxemia in Young Children Undergoing One-lung Ventilation: A Retrospective Cohort Study. Anesthesiology. 2021 Nov 1;135(5):842-853. doi: 10.1097/ALN.0000000000003971.
- Results publication: PubMed 32711826Chandler D, Mosieri C, Kallurkar A, Pham AD, Okada LK, Kaye RJ, Cornett EM, Fox CJ, Urman RD, Kaye AD. Perioperative strategies for the reduction of postoperative pulmonary complications. Best Pract Res Clin Anaesthesiol. 2020 Jun;34(2):153-166. doi: 10.1016/j.bpa.2020.04.011. Epub 2020 Apr 23.
- Results publication: PubMed 29709437iPROVE Network investigators; Belda J, Ferrando C, Garutti I. The Effects of an Open-Lung Approach During One-Lung Ventilation on Postoperative Pulmonary Complications and Driving Pressure: A Descriptive, Multicenter National Study. J Cardiothorac Vasc Anesth. 2018 Dec;32(6):2665-2672. doi: 10.1053/j.jvca.2018.03.028. Epub 2018 Mar 27.
- Results publication: PubMed 32682552Lee JH, Ji SH, Lee HC, Jang YE, Kim EH, Kim HS, Kim JT. Evaluation of the intratidal compliance profile at different PEEP levels in children with healthy lungs: a prospective, crossover study. Br J Anaesth. 2020 Nov;125(5):818-825. doi: 10.1016/j.bja.2020.06.046. Epub 2020 Jul 15.
- Results publication: PubMed 32954753Xu D, Wei W, Chen L, Li S, Lian M. Effects of different positive end-expiratory pressure titrating strategies on oxygenation and respiratory mechanics during one- lung ventilation: a randomized controlled trial. Ann Palliat Med. 2021 Feb;10(2):1133-1144. doi: 10.21037/apm-19-441. Epub 2020 Sep 15.
- Results publication: PubMed 31672709Zhou ZF, Fang JB, Wang HF, He Y, Yu YJ, Xu Q, Ge YF, Zhang MZ, Hu SF. Effects of intraoperative PEEP on postoperative pulmonary complications in high-risk patients undergoing laparoscopic abdominal surgery: study protocol for a randomised controlled trial. BMJ Open. 2019 Oct 30;9(10):e028464. doi: 10.1136/bmjopen-2018-028464.
- Results publication: PubMed 30916035Lee JH, Bae JI, Jang YE, Kim EH, Kim HS, Kim JT. Lung protective ventilation during pulmonary resection in children: a prospective, single-centre, randomised controlled trial. Br J Anaesth. 2019 May;122(5):692-701. doi: 10.1016/j.bja.2019.02.013. Epub 2019 Mar 8.
- Results publication: PubMed 30776290Beitler JR, Sarge T, Banner-Goodspeed VM, Gong MN, Cook D, Novack V, Loring SH, Talmor D; EPVent-2 Study Group. Effect of Titrating Positive End-Expiratory Pressure (PEEP) With an Esophageal Pressure-Guided Strategy vs an Empirical High PEEP-Fio2 Strategy on Death and Days Free From Mechanical Ventilation Among Patients With Acute Respiratory Distress Syndrome: A Randomized Clinical Trial. JAMA. 2019 Mar 5;321(9):846-857. doi: 10.1001/jama.2019.0555.
- Results publication: PubMed 28973363Writing Group for the Alveolar Recruitment for Acute Respiratory Distress Syndrome Trial (ART) Investigators; Cavalcanti AB, Suzumura EA, Laranjeira LN, Paisani DM, Damiani LP, Guimaraes HP, Romano ER, Regenga MM, Taniguchi LNT, Teixeira C, Pinheiro de Oliveira R, Machado FR, Diaz-Quijano FA, Filho MSA, Maia IS, Caser EB, Filho WO, Borges MC, Martins PA, Matsui M, Ospina-Tascon GA, Giancursi TS, Giraldo-Ramirez ND, Vieira SRR, Assef MDGPL, Hasan MS, Szczeklik W, Rios F, Amato MBP, Berwanger O, Ribeiro de Carvalho CR. Effect of Lung Recruitment and Titrated Positive End-Expiratory Pressure (PEEP) vs Low PEEP on Mortality in Patients With Acute Respiratory Distress Syndrome: A Randomized Clinical Trial. JAMA. 2017 Oct 10;318(14):1335-1345. doi: 10.1001/jama.2017.14171.
- Results publication: PubMed 24901240Mazo V, Sabate S, Canet J, Gallart L, de Abreu MG, Belda J, Langeron O, Hoeft A, Pelosi P. Prospective external validation of a predictive score for postoperative pulmonary complications. Anesthesiology. 2014 Aug;121(2):219-31. doi: 10.1097/ALN.0000000000000334.
- Results publication: PubMed 30260897Pereira SM, Tucci MR, Morais CCA, Simoes CM, Tonelotto BFF, Pompeo MS, Kay FU, Pelosi P, Vieira JE, Amato MBP. Individual Positive End-expiratory Pressure Settings Optimize Intraoperative Mechanical Ventilation and Reduce Postoperative Atelectasis. Anesthesiology. 2018 Dec;129(6):1070-1081. doi: 10.1097/ALN.0000000000002435.
- Individual participant dataSharing planned: Yes. All of the individual participant data collected during the trial, after deidentification.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional positive end-expiratory pressure(PEEP) and Lung dynamic compliance guided positive end-expiratory pressure(PEEP) in people with Anesthesia and Surgery, run by Jiaxiang Chen at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pulmonary complication(PPCs) rate at 7 days (time frame: 7 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05386901, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.