Undergoing SurgeryNCT06770179
Effect of Ultrasound-assisted Lung Recruitment Maneuver on Preventing Perioperative Atelectasis
A study testing recruitment maneuver and positional recruitment maneuver in people with Undergoing Surgery and Perioperatif Atelectasis, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
This study is based on the hypothesis that recruitment maneuver reduces perioperative atelectasis and associated complications, and lung ultrasonography can be used to detect this. Read more about this study
- Who is it for?
- Ages 1 year to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Undergoing Surgery, Perioperatif Atelectasis
- What is being tested?
- recruitment maneuver and positional recruitment maneuver
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Nov 2024to 3 Mar 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 year to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Patients aged 1 to 14 years
- ASA scores of 1 to 3
- Minimum surgical duration of 2 hours.
Who cannot join
- Patients with an ASA score of 4,
- Defined lung diseases (such as those using medication for asthma and having a hospital visit within the past year)
- Prematurity ( bronchopulmonary dysplasia)
- Cystic fibrosis
- Diagnosed syndromic conditions
- Congenital cardiac disease
Show all 10Show fewer
- Abnormal lung findings
- Chest wall deformities
- A history of chest surgery
- Those undergoing laparoscopic surgery
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
İstanbul Üniversitesi -Cerrahpaşa,Cerrahpaşa Tıp Fakültesi
Istanbul, 34000
About this study
Official title: Effect of Ultrasound-assisted Lung Recruitment Maneuver on Preventing Perioperative Atelectasis, Prospective Randomized Study
This study is based on the hypothesis that recruitment maneuver reduces perioperative atelectasis and associated complications, and lung ultrasonography can be used to detect this.
Patients aged 1 to 14 years with an ASA physical status classification of 1 to 3 and undergoing surgical procedures with a minimum duration of 2 hours will be included in the study.
Read more
Patients with an ASA physical status classification of 4, including those with defined pulmonary diseases (e.g., asthma requiring medication and having had two emergency visits in the past year), prematurity ( <36 weeks gestation / bronchopulmonary dysplasia), cystic fibrosis, diagnosed syndromic conditions, congenital cardiac diseases, abnormal chest X-rays, chest wall deformities, or a history of previous thoracic surgery, as well as those undergoing laparoscopic surgery, will be excluded from the study.
All patients will be premedicated with midazolam (0.05-1 mg/kg) if intravenous access is established, prior to transfer to the operating room. Upon arrival, standard monitoring will be initiated, including SpO2, ECG, and non-invasive blood pressure measurements. Following preoxygenation with 100% oxygen, induction will be performed using thiopental 5 mg/kg or propofol 2 mg/kg, fentanyl 2 mcg/kg, and rocuronium 0.6 mg/kg. After tracheal intubation, mechanical ventilation will be configured in pressure-controlled mode with a tidal volume of 8 ml/kg, PEEP of 5 cmH2O, FIO2 of 40%, and a respiratory rate adjusted to maintain ETCO2 within the range of 35-45 mmHg. Anesthesia maintenance will be achieved with sevoflurane and oxygen. During emergence, sugammadex 2 mg/kg will be administered as a neuromuscular reversal agent. The Aldrete scoring system will be employed for assessing patient readiness for transfer to the recovery unit.
GROUP 1: PEEP will be set at 5 cmH2O, and no recruitment maneuver will be performed.
GROUP 2: PEEP will be set at 5 cmH2O. Prior to extubation, a recruitment maneuver will be conducted with a Plato P max : 35 cmH2O, delivering 6 breaths at a vital capacity of 2 times, with an I/E ratio of 1:1.
GROUP 3: PEEP will be set at 5 cmH2O. Prior to extubation, a recruitment maneuver will be performed with a Plato P max : 35 cmH2O, delivering 3 breaths in the left lateral decubitus position and 3 breaths in the right lateral decubitus position, at a vital capacity of 2 times, with an I/E ratio of 1:1.
Lung ultrasonography will be performed at the following time points: 1) before induction, 2) at the 5-minute mark after induction, 3) before the recruitment maneuver, and 4) at the 5-minute mark after extubation.
The lungs will be assessed by dividing each hemithorax into 6 regions. Evaluation will include pleural sliding, A-lines, air bronchograms, B-score, and consolidation score. Both PLAPS points will be evaluated for B-score and consolidation score.
From the beginning of the operation, the following parameters will be recorded hourly: heart rate (HR), arterial blood pressure (ABP), oxygen saturation (SpO2), fraction of inspired oxygen (FIO2), end-tidal CO2 (ETCO2), peak pressure (Ppeak), PLATO pressure, delta pressure, and compliance.
During the postoperative 24-hour period, the following will be documented: temperature, desaturation, oxygen requirement, and the need for additional radiological investigations.
Read the detailed description
Postoperative pulmonary complications are associated with increased mortality and morbidity. These complications occur in 2.8 % of all patients, and the rate can reach 14.5% in high-risk surgeries. Mechanical ventilation aims to improve gas exchange, reduce respiratory work, and provide sedation and muscle relaxation. While achieving these goals, it is crucial to avoid ventilator-induced lung injury. Given that approximately 234 million people are mechanically ventilated during anesthesia each year, reducing the effects of anesthesia and mechanical ventilation is of great importance. Therefore, efforts are ongoing to develop protective ventilation strategies during anesthesia.
The primary function of the lungs is to ensure adequate gas exchange by maintaining normal oxygen levels in the blood and eliminating carbon dioxide. This is achieved by optimizing lung volumes during the perioperative period. General anesthesia causes changes in respiratory physiology, affecting both oxygenation and carbon dioxide elimination. The effects of anesthesia on pulmonary function continue into the postoperative period, impacting pulmonary function. Factors influencing pulmonary function include loss of consciousness, ventilation mode, patient positioning, and the effects of anesthetic agents. These effects manifest as changes in lung volumes, airway resistance, and compliance, which in turn alter the ventilation/perfusion (V/Q) ratio. While newer agents used in anesthesia practice may have fewer side effects, they do not eliminate all the adverse effects of general anesthesia. A thorough understanding of pulmonary physiology helps in preventing potential complications during anesthesia and the postoperative period.
Atelectasis occurs in most patients under general anesthesia, with an incidence rate in children ranging from 68% to 100%. Respiratory complications, including atelectasis, are the most common adverse events in pediatric anesthesia. Smaller children and infants are particularly susceptible to hypoxemia due to their smaller residual capacities and increased metabolic demands. Atelectasis affects oxygenation in these children and exacerbates respiratory problems. This condition represents a significant issue that requires careful monitoring and intervention during surgery and anesthesia.
In recent years, lung ultrasound has been increasingly used for this purpose. It has a wide range of applications, including the verification of intubation, detection of pneumothorax, pleural effusion, pulmonary edema, and atelectasis.
Applying PEEP and performing recruitment maneuvers are beneficial for preventing atelectasis. However, data on the duration, frequency, and exact application of these techniques in pediatric age groups are limited.
Among the methods for detecting atelectasis, lung ultrasound is increasingly recognized as a rapid, simple, non-invasive, and radiation-free technique. Lung ultrasound has demonstrated reliable sensitivity and specificity in diagnosing anesthesia-related atelectasis in children .
The importance of preventing atelectasis, especially in the pediatric age group, is significant. Therefore, in our study, we aimed to assess the degree of anesthesia-related atelectasis in children using lung ultrasound and to evaluate the effectiveness of recruitment maneuvers in preventing respiratory complications
In the power analysis conducted before the study, based on previous studies, the minimum sample size required to achieve an effect size (f) of 0.4, a Type I error rate of 0.05, a Type II error rate of 0.20, and a power of 0.80 was found to be 66 participants. Considering a 20% dropout rate during the follow-up period, a total of 78 patients were decided to be included in the study.
Patients aged 1 to 14 years with an ASA physical status classification of 1 to 3 and undergoing surgical procedures with a minimum duration of 2 hours will be included in the study.
Patients with an ASA physical status classification of 4, including those with defined pulmonary diseases (e.g., asthma requiring medication and having had two emergency visits in the past year), prematurity ( < 36 weeks gestation / bronchopulmonary dysplasia), cystic fibrosis, diagnosed syndromic conditions, congenital cardiac diseases, abnormal chest X-rays, chest wall deformities, or a history of previous thoracic surgery, as well as those undergoing laparoscopic surgery, will be excluded from the study.
All patients will be premedicated with midazolam (0.05-1 mg/kg) if intravenous access is established, prior to transfer to the operating room. Upon arrival, standard monitoring will be initiated, including SpO2, ECG, and non-invasive blood pressure measurements. Following preoxygenation with 100% oxygen, induction will be performed using thiopental 5 mg/kg or propofol 2 mg/kg, fentanyl 2 mcg/kg, and rocuronium 0.6 mg/kg. After tracheal intubation, mechanical ventilation will be configured in pressure-controlled mode with a tidal volume of 8 ml/kg, PEEP of 5 cmH2O, FIO2 of 40%, and a respiratory rate adjusted to maintain EtCO2 within the range of 35-45 mmHg. Anesthesia maintenance will be achieved with sevoflurane and oxygen. During emergence, sugammadex 2 mg/kg will be administered as a neuromuscular reversal agent. The Aldrete scoring system will be employed for assessing patient readiness for transfer to the recovery unit.
GROUP 1: PEEP will be set at 5 cmH2O, and no recruitment maneuver will be performed.
GROUP 2: PEEP will be set at 5 cmH2O. Prior to extubation, a recruitment maneuver will be conducted with a Plato P max :35 cmH2O, delivering 6 breaths at a vital capacity of 2 times, with an I/E ratio of 1:1.
GROUP 3: PEEP will be set at 5 cmH2O. Prior to extubation, a recruitment maneuver will be performed with a Plato P max : 35 cmH2O, delivering 3 breaths in the left lateral decubitus position and 3 breaths in the right lateral decubitus position, at a vital capacity of 2 times, with an I/E ratio of 1:1.
Lung ultrasonography will be performed at the following time points: 1) before induction, 2) at the 5-minute mark after induction, 3) before the recruitment maneuver, and 4) at the 5-minute mark after extubation.
The lungs will be assessed by dividing each hemithorax into 6 regions. Evaluation will include pleural sliding, A-lines, air bronchograms, B-score, and consolidation score. Both PLAPS points will be evaluated for B-score and consolidation score.
From the beginning of the operation, the following parameters will be recorded hourly: heart rate (HR), arterial blood pressure (ABP), oxygen saturation (SpO2), fraction of inspired oxygen (FIO2), end-tidal CO2 (ETCO2), peak pressure (Ppeak), PLATO pressure, delta pressure, and compliance.
During the postoperative 24-hour period, the following will be documented: temperature, desaturation, oxygen requirement, and the need for additional radiological investigations.
- Conditions
- Undergoing Surgery, Perioperatif Atelectasis
- Being tested
- recruitment maneuver, positional recruitment maneuver
- Keywords
- perioperatif atelectasis, Recruitment maneuver, lung ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
recruitment maneuverOther
in the group 2, in addition to the fixed PEEP of 5 cm H₂O, a recruitment maneuver is planned at the end of the surgery. This will involve administering 6 breaths with VC × 2, I/E ratio of 1:1, and a plateau pressure of less than 35 cm H₂O, before extubation.
positional recruitment maneuverOther
In the third group, in addition to the fixed PEEP, a recruitment maneuver will be performed at the end of the surgery before extubation. This will involve administering 6 breaths with VC × 2, I/E ratio of 1:1, and a plateau pressure of less than 35 cm H₂O, with 3 breaths in the right lateral decubitus position and 3 breaths in the left lateral decubitus position
| Study group | Role | What they receive |
|---|---|---|
| group 1 | No intervention | Patients in this group will receive a fixed PEEP of 5 cm H₂O during the perioperative period. |
| group 2 | Experimental | In addition to the fixed PEEP of 5 cm H₂O, a recruitment maneuver will be performed at the end of the surgery. Receives: Other: recruitment maneuver |
| group 3 | Experimental | In addition to the fixed PEEP of 5 cm H₂O, a positional recruitment maneuver will be performed at the end of the surgery. Receives: Other: positional recruitment maneuver |
What is being measured
The primary outcome is the main question the study is designed to answer.
B scores
Each hemithorax will be divided into six regions using three longitudinal (parasternal, anterior axillary, and posterior axillary) and two transverse (1 cm above the nipple line and diaphragm) lines. Each region will be scanned sequentially from right to left, top to bottom, and front to back, with the probe perpendicular to the ribs. Pleural sliding, A-lines, air bronchograms, juxtapleural consolidation, and B-lines will be assessed. Additionally, B scores will be evaluated at two specific PLAPS points.
Measured: Perioperative (Lung ultrasound will be performed four times on each patient: T1: Pre-induction T2: 5 minutes after induction T3: Pre-recruitment maneuver T4: 5 minutes after extubation.)
Consolidation Scores
Each hemithorax will be divided into six regions using three longitudinal (parasternal, anterior axillary, and posterior axillary) and two transverse (1 cm above the nipple line and diaphragm) lines. Each region will be scanned sequentially from right to left, top to bottom, and front to back, with the probe perpendicular to the ribs. Consolidation scores will be evaluated at two specific PLAPS points
Measured: Perioperative ( Lung ultrasound will be performed four times on each patient: T1: Pre-induction T2: 5 minutes after induction T3: Pre-recruitment maneuver T4: 5 minutes after extubation.)
Secondary outcomes (8)
HR
Starting from the pre-induction period and continuing at 5 minutes after intubation and every subsequent hour, the values for HR will be recorded.
Measured: perioperative
SpO₂
Starting from the pre-induction period and continuing at 5 minutes after intubation and every subsequent hour, the values for SpO₂ will be recorded.
Measured: perioperative
MAP
Starting from the pre-induction period and continuing at 5 minutes after intubation and every subsequent hour, the values for MAP will be recorded.
Measured: Perioperative
ETCO2
Starting from the pre-induction period and continuing at 5 minutes after intubation and every subsequent hour, the values for ETCO₂ will be recorded.
Measured: Perioperative
Peak P
Starting from the pre-induction period and continuing at 5 minutes after intubation and every subsequent hour, the values for Peak P will be recorded.
Measured: Perioperative
Plateau P
Starting from the pre-induction period and continuing at 5 minutes after intubation and every subsequent hour, the values for Plateau P will be recorded.
Measured: perioperative
Delta P
Starting from the pre-induction period and continuing at 5 minutes after intubation and every subsequent hour, the values forDelta P will be recorded.
Measured: Perioperative
Compliance
Starting from the pre-induction period and continuing at 5 minutes after intubation and every subsequent hour, the values for compliance will be recorded.
Measured: perioperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2025
- Study start25 Nov 2024
- Primary completion28 Feb 2025 (estimated)
- Study completion3 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Undergoing SurgeryStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Şeyma Karaduman Bulut, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06770179
- Sponsor's protocol ID
- E-83045809-604.01-904144
- Status last verified
- Jan 2025
- First submitted
- 20 Nov 2024
- Last updated
- 13 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Ultrasound-assisted Lung Recruitment Maneuver on Preventing Perioperative Atelectasis, Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT06770179
- Acronym / sponsor ID
- E-83045809-604.01-904144
- Conditions
- Undergoing Surgery, Perioperatif Atelectasis
- Keywords
- perioperatif atelectasis, Recruitment maneuver, lung ultrasound
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 25 Nov 2024 (actual)
- Primary completion
- 28 Feb 2025 (estimated)
- Study completion
- 3 Mar 2025 (estimated)
- First posted
- 13 Jan 2025 (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 is based on the hypothesis that recruitment maneuver reduces perioperative atelectasis and associated complications, and lung ultrasonography can be used to detect this.
Patients aged 1 to 14 years with an ASA physical status classification of 1 to 3 and undergoing surgical procedures with a minimum duration of 2 hours will be included in the study.
Patients with an ASA physical status classification of 4, including those with defined pulmonary diseases (e.g., asthma requiring medication and having had two emergency visits in the past year), prematurity ( <36 weeks gestation / bronchopulmonary dysplasia), cystic fibrosis, diagnosed syndromic conditions, congenital cardiac diseases, abnormal chest X-rays, chest wall deformities, or a history of previous thoracic surgery, as well as those undergoing laparoscopic surgery, will be excluded from the study.
All patients will be premedicated with midazolam (0.05-1 mg/kg) if intravenous access is established, prior to transfer to the operating room. Upon arrival, standard monitoring will be initiated, including SpO2, ECG, and non-invasive blood pressure measurements. Following preoxygenation with 100% oxygen, induction will be performed using thiopental 5 mg/kg or propofol 2 mg/kg, fentanyl 2 mcg/kg, and rocuronium 0.6 mg/kg. After tracheal intubation, mechanical ventilation will be configured in pressure-controlled mode with a tidal volume of 8 ml/kg, PEEP of 5 cmH2O, FIO2 of 40%, and a respiratory rate adjusted to maintain ETCO2 within the range of 35-45 mmHg. Anesthesia maintenance will be achieved with sevoflurane and oxygen. During emergence, sugammadex 2 mg/kg will be administered as a neuromuscular reversal agent. The Aldrete scoring system will be employed for assessing patient readiness for transfer to the recovery unit.
GROUP 1: PEEP will be set at 5 cmH2O, and no recruitment maneuver will be performed.
GROUP 2: PEEP will be set at 5 cmH2O. Prior to extubation, a recruitment maneuver will be conducted with a Plato P max : 35 cmH2O, delivering 6 breaths at a vital capacity of 2 times, with an I/E ratio of 1:1.
GROUP 3: PEEP will be set at 5 cmH2O. Prior to extubation, a recruitment maneuver will be performed with a Plato P max : 35 cmH2O, delivering 3 breaths in the left lateral decubitus position and 3 breaths in the right lateral decubitus position, at a vital capacity of 2 times, with an I/E ratio of 1:1.
Lung ultrasonography will be performed at the following time points: 1) before induction, 2) at the 5-minute mark after induction, 3) before the recruitment maneuver, and 4) at the 5-minute mark after extubation.
The lungs will be assessed by dividing each hemithorax into 6 regions. Evaluation will include pleural sliding, A-lines, air bronchograms, B-score, and consolidation score. Both PLAPS points will be evaluated for B-score and consolidation score.
From the beginning of the operation, the following parameters will be recorded hourly: heart rate (HR), arterial blood pressure (ABP), oxygen saturation (SpO2), fraction of inspired oxygen (FIO2), end-tidal CO2 (ETCO2), peak pressure (Ppeak), PLATO pressure, delta pressure, and compliance.
During the postoperative 24-hour period, the following will be documented: temperature, desaturation, oxygen requirement, and the need for additional radiological investigations.
Detailed description
Postoperative pulmonary complications are associated with increased mortality and morbidity. These complications occur in 2.8 % of all patients, and the rate can reach 14.5% in high-risk surgeries. Mechanical ventilation aims to improve gas exchange, reduce respiratory work, and provide sedation and muscle relaxation. While achieving these goals, it is crucial to avoid ventilator-induced lung injury. Given that approximately 234 million people are mechanically ventilated during anesthesia each year, reducing the effects of anesthesia and mechanical ventilation is of great importance. Therefore, efforts are ongoing to develop protective ventilation strategies during anesthesia.
The primary function of the lungs is to ensure adequate gas exchange by maintaining normal oxygen levels in the blood and eliminating carbon dioxide. This is achieved by optimizing lung volumes during the perioperative period. General anesthesia causes changes in respiratory physiology, affecting both oxygenation and carbon dioxide elimination. The effects of anesthesia on pulmonary function continue into the postoperative period, impacting pulmonary function. Factors influencing pulmonary function include loss of consciousness, ventilation mode, patient positioning, and the effects of anesthetic agents. These effects manifest as changes in lung volumes, airway resistance, and compliance, which in turn alter the ventilation/perfusion (V/Q) ratio. While newer agents used in anesthesia practice may have fewer side effects, they do not eliminate all the adverse effects of general anesthesia. A thorough understanding of pulmonary physiology helps in preventing potential complications during anesthesia and the postoperative period.
Atelectasis occurs in most patients under general anesthesia, with an incidence rate in children ranging from 68% to 100%. Respiratory complications, including atelectasis, are the most common adverse events in pediatric anesthesia. Smaller children and infants are particularly susceptible to hypoxemia due to their smaller residual capacities and increased metabolic demands. Atelectasis affects oxygenation in these children and exacerbates respiratory problems. This condition represents a significant issue that requires careful monitoring and intervention during surgery and anesthesia.
In recent years, lung ultrasound has been increasingly used for this purpose. It has a wide range of applications, including the verification of intubation, detection of pneumothorax, pleural effusion, pulmonary edema, and atelectasis.
Applying PEEP and performing recruitment maneuvers are beneficial for preventing atelectasis. However, data on the duration, frequency, and exact application of these techniques in pediatric age groups are limited.
Among the methods for detecting atelectasis, lung ultrasound is increasingly recognized as a rapid, simple, non-invasive, and radiation-free technique. Lung ultrasound has demonstrated reliable sensitivity and specificity in diagnosing anesthesia-related atelectasis in children .
The importance of preventing atelectasis, especially in the pediatric age group, is significant. Therefore, in our study, we aimed to assess the degree of anesthesia-related atelectasis in children using lung ultrasound and to evaluate the effectiveness of recruitment maneuvers in preventing respiratory complications
In the power analysis conducted before the study, based on previous studies, the minimum sample size required to achieve an effect size (f) of 0.4, a Type I error rate of 0.05, a Type II error rate of 0.20, and a power of 0.80 was found to be 66 participants. Considering a 20% dropout rate during the follow-up period, a total of 78 patients were decided to be included in the study.
Patients aged 1 to 14 years with an ASA physical status classification of 1 to 3 and undergoing surgical procedures with a minimum duration of 2 hours will be included in the study.
Patients with an ASA physical status classification of 4, including those with defined pulmonary diseases (e.g., asthma requiring medication and having had two emergency visits in the past year), prematurity ( < 36 weeks gestation / bronchopulmonary dysplasia), cystic fibrosis, diagnosed syndromic conditions, congenital cardiac diseases, abnormal chest X-rays, chest wall deformities, or a history of previous thoracic surgery, as well as those undergoing laparoscopic surgery, will be excluded from the study.
All patients will be premedicated with midazolam (0.05-1 mg/kg) if intravenous access is established, prior to transfer to the operating room. Upon arrival, standard monitoring will be initiated, including SpO2, ECG, and non-invasive blood pressure measurements. Following preoxygenation with 100% oxygen, induction will be performed using thiopental 5 mg/kg or propofol 2 mg/kg, fentanyl 2 mcg/kg, and rocuronium 0.6 mg/kg. After tracheal intubation, mechanical ventilation will be configured in pressure-controlled mode with a tidal volume of 8 ml/kg, PEEP of 5 cmH2O, FIO2 of 40%, and a respiratory rate adjusted to maintain EtCO2 within the range of 35-45 mmHg. Anesthesia maintenance will be achieved with sevoflurane and oxygen. During emergence, sugammadex 2 mg/kg will be administered as a neuromuscular reversal agent. The Aldrete scoring system will be employed for assessing patient readiness for transfer to the recovery unit.
GROUP 1: PEEP will be set at 5 cmH2O, and no recruitment maneuver will be performed.
GROUP 2: PEEP will be set at 5 cmH2O. Prior to extubation, a recruitment maneuver will be conducted with a Plato P max :35 cmH2O, delivering 6 breaths at a vital capacity of 2 times, with an I/E ratio of 1:1.
GROUP 3: PEEP will be set at 5 cmH2O. Prior to extubation, a recruitment maneuver will be performed with a Plato P max : 35 cmH2O, delivering 3 breaths in the left lateral decubitus position and 3 breaths in the right lateral decubitus position, at a vital capacity of 2 times, with an I/E ratio of 1:1.
Lung ultrasonography will be performed at the following time points: 1) before induction, 2) at the 5-minute mark after induction, 3) before the recruitment maneuver, and 4) at the 5-minute mark after extubation.
The lungs will be assessed by dividing each hemithorax into 6 regions. Evaluation will include pleural sliding, A-lines, air bronchograms, B-score, and consolidation score. Both PLAPS points will be evaluated for B-score and consolidation score.
From the beginning of the operation, the following parameters will be recorded hourly: heart rate (HR), arterial blood pressure (ABP), oxygen saturation (SpO2), fraction of inspired oxygen (FIO2), end-tidal CO2 (ETCO2), peak pressure (Ppeak), PLATO pressure, delta pressure, and compliance.
During the postoperative 24-hour period, the following will be documented: temperature, desaturation, oxygen requirement, and the need for additional radiological investigations.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| group 1 | No intervention | –Patients in this group will receive a fixed PEEP of 5 cm H₂O during the perioperative period. |
| group 2 | Experimental | Other: recruitment maneuverIn addition to the fixed PEEP of 5 cm H₂O, a recruitment maneuver will be performed at the end of the surgery. |
| group 3 | Experimental | Other: positional recruitment maneuverIn addition to the fixed PEEP of 5 cm H₂O, a positional recruitment maneuver will be performed at the end of the surgery. |
Who may qualify
- Ages
- 1 year to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Patients aged 1 to 14 years
- ASA scores of 1 to 3
- Minimum surgical duration of 2 hours.
Key exclusion criteria (10 listed)
- Patients with an ASA score of 4,
- Defined lung diseases (such as those using medication for asthma and having a hospital visit within the past year)
- Prematurity ( bronchopulmonary dysplasia)
- Cystic fibrosis
- Diagnosed syndromic conditions
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 |
|---|---|---|
| recruitment maneuverin the group 2, in addition to the fixed PEEP of 5 cm H₂O, a recruitment maneuver is planned at the end of the surgery. This will involve administering 6 breaths with VC × 2, I/E ratio of 1:1, and a plateau pressure of less than 35 cm H₂O, before extubation. | Other | group 2 |
| positional recruitment maneuverIn the third group, in addition to the fixed PEEP, a recruitment maneuver will be performed at the end of the surgery before extubation. This will involve administering 6 breaths with VC × 2, I/E ratio of 1:1, and a plateau pressure of less than 35 cm H₂O, with 3 breaths in the right lateral decubitus position and 3 breaths in the left lateral decubitus position | Other | group 3 |
Primary outcome
B scores
Time frame: Perioperative (Lung ultrasound will be performed four times on each patient: T1: Pre-induction T2: 5 minutes after induction T3: Pre-recruitment maneuver T4: 5 minutes after extubation.)
Each hemithorax will be divided into six regions using three longitudinal (parasternal, anterior axillary, and posterior axillary) and two transverse (1 cm above the nipple line and diaphragm) lines. Each region will be scanned sequentially from right to left, top to bottom, and front to back, with the probe perpendicular to the ribs. Pleural sliding, A-lines, air bronchograms, juxtapleural consolidation, and B-lines will be assessed. Additionally, B scores will be evaluated at two specific PLAPS points.
Consolidation Scores
Time frame: Perioperative ( Lung ultrasound will be performed four times on each patient: T1: Pre-induction T2: 5 minutes after induction T3: Pre-recruitment maneuver T4: 5 minutes after extubation.)
Each hemithorax will be divided into six regions using three longitudinal (parasternal, anterior axillary, and posterior axillary) and two transverse (1 cm above the nipple line and diaphragm) lines. Each region will be scanned sequentially from right to left, top to bottom, and front to back, with the probe perpendicular to the ribs. Consolidation scores will be evaluated at two specific PLAPS points
8 secondary outcomes
HR
Time frame: perioperative
SpO₂
Time frame: perioperative
MAP
Time frame: Perioperative
ETCO2
Time frame: Perioperative
Peak P
Time frame: Perioperative
Plateau P
Time frame: perioperative
Delta P
Time frame: Perioperative
Compliance
Time frame: perioperative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2025.
- Individual participant dataSharing planned: Undecided
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rhTPO for Thrombocytopenia in Chronic Liver Disease Patients Undergoing Elective Invasive Procedures.
Thrombocytopenia Associated With Chronic Liver Disease
RecruitingObservational study
The Impact of Fast-Track Anesthesia on Postoperative Neurocognitive Function in Patients Undergoing Cardiac Surgery
Delirium - Postoperative, Cardiac Surgery
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.
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 recruitment maneuver and positional recruitment maneuver in people with Undergoing Surgery and Perioperatif Atelectasis, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
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 3 inclusion and 10 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: enrolling by invitation, as of the sponsor's last update on 13 Jan 2025. 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 Turkey (Türkiye). 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?
This study is still under way. Results are not available in the source record yet.
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?
B scores (time frame: Perioperative (Lung ultrasound will be performed four times on each patient: T1: Pre-induction T2: 5 minutes after induction T3: Pre-recruitment maneuver T4: 5 minutes after extubation.)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Jan 2025.