Dynamic Lung ComplianceNCT07161466
Effects of Positive End-Expiratory Pressure Levels on Lung Recruitment Duration and Hemodynamics After Alveolar Recruitment Maneuver: A Randomized Clinical Trial
A study testing lung recruitment maneuvre; PEEP in people with Dynamic Lung Compliance and Alveolar Recruitment Maneuver, run by Northern Jiangsu People's Hospital at 1 site in China.
Trial summary
During general anesthesia surgery, the role of positive end-expiratory pressure (PEEP) in mechanical ventilation remains uncertain. Pressure levels above 0 cm H₂O can prevent postoperative pulmonary complications but may also cause intraoperative circulatory depression and lung injury due to overdistension. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Dynamic Lung Compliance, Alveolar Recruitment Maneuver
- What is being tested?
- lung recruitment maneuvre; PEEP
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 101 participants
- Where
- 1 siteChina
- Study dates
- 30 Aug 2025to 30 Nov 2025
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA physical status classification: Ⅰ or Ⅱ or Ⅲ
- Adults aged 18 to 80 years, regardless of gender.
- Patients undergoing elective laparoscopic colorectal cancer surgery under general anesthesia.
- Patients who have provided written informed consent after understanding the study purpose, procedures, and potential risks.
Who cannot join
- Recent thoracic surgery; radiographic evidence of pneumothorax, emphysema, or pulmonary bullae;
- Pulmonary diseases: asthma or severe obstructive ventilatory dysfunction; preoperative pulse oxygen saturation (SpO2) < 90% on room air or < 95% with supplemental oxygen; contraindications to ARMs (e.g., intracranial hypertension, hypovolemic shock, or right heart failure);
- severe cardiac disease (NYHA class III/IV, acute coronary syndrome, sustained ventricular tachycardia); concurrent participation in another trial; or refusal to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
During general anesthesia surgery, the role of positive end-expiratory pressure (PEEP) in mechanical ventilation remains uncertain. Pressure levels above 0 cm H₂O can prevent postoperative pulmonary complications but may also cause intraoperative circulatory depression and lung injury due to overdistension. Using very low levels of PEEP may lead to atelectasis. However, high levels of PEEP can not only trigger complications such as intraoperative circulatory depression but also promote hyperinflation. Positive end-expiratory pressure (PEEP) is required to prevent atelectasis during lung-protective ventilation, and different levels of PEEP exhibit varying physiological and clinical effects when used alone or in combination with alveolar recruitment maneuvers (ARM). Alveolar recruitment maneuvers (ARM) are used to open atelectatic lung parenchyma, but the duration of their benefits has not been clearly determined. This study aims to determine the effectiveness of different PEEP levels after ARM in general anesthesia surgery, the duration of their time-dependent responses, and their hemodynamic effects, providing a reference for how often recruitment maneuvers should be performed during general anesthesia and further refining the specific details of lung-protective ventilation strategies.
- Being tested
- lung recruitment maneuvre; PEEP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lung recruitment maneuvre; PEEPBehavioural
After the patient enters the operating room, routine monitoring of ECG, non-invasive blood pressure, and SpO₂ is performed. Local anesthesia is used for radial artery puncture and catheterization to monitor invasive blood pressure.
After 3 minutes of pre-oxygenation, tracheal intubation is performed with the following ventilation parameters: VT 6-8 ml/kg, FiO₂ 60%, RR 15 breaths/min, I/E 1:2, and PEEP 4 cmH₂O. Ten minutes after the establishment of pneumoperitoneum during surgery, baseline levels of respiratory mechanical parameters and hemodynamic variables are recorded. Subsequently, alveolar recruitment is performed at a pressure of 30 cmH₂O for 30 seconds. Immediately after recruitment, the PEEP level is adjusted according to the group. The changes in respiratory mechanics parameters and hemodynamic variables after recruitment are recorded. After the outcome indicators recover to the new baseline level, the PEEP is readjusted to 4 cmH₂O.
| Study group | Role | What they receive |
|---|---|---|
| A: PEEP=0 cmH2O | Placebo comparator | Baseline respiratory mechanics parameters (driving pressure [DP], dynamic lung compliance [Cdyn]) and hemodynamic parameters (mean arterial pressure [MAP], SV, CO, CI) were recorded before ARM. Ten minutes after insufflation of the peritoneum with CO2 and positioning of the patient for surgery, an ARM was performed using the built-in protocol of the Mindray anesthesia machine, applying a continuous positive pressure of 30 cmH2O for 30 seconds. Immediately afterwards, the PEEP level was adjusted to 0 cmH2O. Respiratory and hemodynamic parameters were recorded at 5, 10, 15, 20, 25, 30, 35, and 40 minutes after ARM. The PEEP level was set back to 4 cmH2O forty minutes after ARM until the end of surgery. Receives: Behavioral: lung recruitment maneuvre; PEEP |
| B: PEEP=4cmH2O | Experimental | Baseline respiratory mechanics parameters (driving pressure [DP], dynamic lung compliance [Cdyn]) and hemodynamic parameters (mean arterial pressure [MAP], SV, CO, CI) were recorded before ARM. Ten minutes after insufflation of the peritoneum with CO2 and positioning of the patient for surgery, an ARM was performed using the built-in protocol of the Mindray anesthesia machine, applying a continuous positive pressure of 30 cmH2O for 30 seconds. Immediately afterwards, the PEEP level was adjusted to 4 cmH2O. Respiratory and hemodynamic parameters were recorded at 5, 10, 15, 20, 25, 30, 35, and 40 minutes after ARM. The PEEP level was set back to 4 cmH2O forty minutes after ARM until the end of surgery. Receives: Behavioral: lung recruitment maneuvre; PEEP |
| C: PEEP=8cmH2O | Experimental | Baseline respiratory mechanics parameters (driving pressure [DP], dynamic lung compliance [Cdyn]) and hemodynamic parameters (mean arterial pressure [MAP], SV, CO, CI) were recorded before ARM. Ten minutes after insufflation of the peritoneum with CO2 and positioning of the patient for surgery, an ARM was performed using the built-in protocol of the Mindray anesthesia machine, applying a continuous positive pressure of 30 cmH2O for 30 seconds. Immediately afterwards, the PEEP level was adjusted to 8 cmH2O. Respiratory and hemodynamic parameters were recorded at 5, 10, 15, 20, 25, 30, 35, and 40 minutes after ARM. The PEEP level was set back to 4 cmH2O forty minutes after ARM until the end of surgery. Receives: Behavioral: lung recruitment maneuvre; PEEP |
| D: PEEP=12cmH2O | Experimental | Baseline respiratory mechanics parameters (driving pressure [DP], dynamic lung compliance [Cdyn]) and hemodynamic parameters (mean arterial pressure [MAP], SV, CO, CI) were recorded before ARM. Ten minutes after insufflation of the peritoneum with CO2 and positioning of the patient for surgery, an ARM was performed using the built-in protocol of the Mindray anesthesia machine, applying a continuous positive pressure of 30 cmH2O for 30 seconds. Immediately afterwards, the PEEP level was adjusted to 12 cmH2O. Respiratory and hemodynamic parameters were recorded at 5, 10, 15, 20, 25, 30, 35, and 40 minutes after ARM. The PEEP level was set back to 4 cmH2O forty minutes after ARM until the end of surgery. Receives: Behavioral: lung recruitment maneuvre; PEEP |
What is being measured
The primary outcome is the main question the study is designed to answer.
the duration of improvement in lung compliance
Measured: during the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2025
- Study start30 Aug 2025
- Primary completion30 Nov 2025
- Study completion30 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dynamic Lung ComplianceStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northern Jiangsu People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ju Gao, Northern Jiangsu People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07161466
- Sponsor's protocol ID
- 2024ky380
- Status last verified
- Aug 2025
- First submitted
- 30 Aug 2025
- Last updated
- 24 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Positive End-Expiratory Pressure Levels on Lung Recruitment Duration and Hemodynamics After Alveolar Recruitment Maneuver: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07161466
- Acronym / sponsor ID
- 2024ky380
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Northern Jiangsu People's HospitalUniversity, hospital or other
- Study start
- 30 Aug 2025 (actual)
- Primary completion
- 30 Nov 2025 (actual)
- Study completion
- 30 Nov 2025 (actual)
- First posted
- 8 Sep 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.
During general anesthesia surgery, the role of positive end-expiratory pressure (PEEP) in mechanical ventilation remains uncertain. Pressure levels above 0 cm H₂O can prevent postoperative pulmonary complications but may also cause intraoperative circulatory depression and lung injury due to overdistension. Using very low levels of PEEP may lead to atelectasis. However, high levels of PEEP can not only trigger complications such as intraoperative circulatory depression but also promote hyperinflation. Positive end-expiratory pressure (PEEP) is required to prevent atelectasis during lung-protective ventilation, and different levels of PEEP exhibit varying physiological and clinical effects when used alone or in combination with alveolar recruitment maneuvers (ARM). Alveolar recruitment maneuvers (ARM) are used to open atelectatic lung parenchyma, but the duration of their benefits has not been clearly determined. This study aims to determine the effectiveness of different PEEP levels after ARM in general anesthesia surgery, the duration of their time-dependent responses, and their hemodynamic effects, providing a reference for how often recruitment maneuvers should be performed during general anesthesia and further refining the specific details of lung-protective ventilation strategies.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A: PEEP=0 cmH2O | Placebo comparator | Behavioral: lung recruitment maneuvre; PEEPBaseline respiratory mechanics parameters (driving pressure [DP], dynamic lung compliance [Cdyn]) and hemodynamic parameters (mean arterial pressure [MAP], SV, CO, CI) were recorded before ARM. Ten minutes after insufflation of the peritoneum with CO2 and positioning of the patient for surgery, an ARM was performed using the built-in protocol of the Mindray anesthesia machine, applying a continuous positive pressure of 30 cmH2O for 30 seconds. Immediately afterwards, the PEEP level was adjusted to 0 cmH2O. Respiratory and hemodynamic parameters were recorded at 5, 10, 15, 20, 25, 30, 35, and 40 minutes after ARM. The PEEP level was set back to 4 cmH2O forty minutes after ARM until the end of surgery. |
| B: PEEP=4cmH2O | Experimental | Behavioral: lung recruitment maneuvre; PEEPBaseline respiratory mechanics parameters (driving pressure [DP], dynamic lung compliance [Cdyn]) and hemodynamic parameters (mean arterial pressure [MAP], SV, CO, CI) were recorded before ARM. Ten minutes after insufflation of the peritoneum with CO2 and positioning of the patient for surgery, an ARM was performed using the built-in protocol of the Mindray anesthesia machine, applying a continuous positive pressure of 30 cmH2O for 30 seconds. Immediately afterwards, the PEEP level was adjusted to 4 cmH2O. Respiratory and hemodynamic parameters were recorded at 5, 10, 15, 20, 25, 30, 35, and 40 minutes after ARM. The PEEP level was set back to 4 cmH2O forty minutes after ARM until the end of surgery. |
| C: PEEP=8cmH2O | Experimental | Behavioral: lung recruitment maneuvre; PEEPBaseline respiratory mechanics parameters (driving pressure [DP], dynamic lung compliance [Cdyn]) and hemodynamic parameters (mean arterial pressure [MAP], SV, CO, CI) were recorded before ARM. Ten minutes after insufflation of the peritoneum with CO2 and positioning of the patient for surgery, an ARM was performed using the built-in protocol of the Mindray anesthesia machine, applying a continuous positive pressure of 30 cmH2O for 30 seconds. Immediately afterwards, the PEEP level was adjusted to 8 cmH2O. Respiratory and hemodynamic parameters were recorded at 5, 10, 15, 20, 25, 30, 35, and 40 minutes after ARM. The PEEP level was set back to 4 cmH2O forty minutes after ARM until the end of surgery. |
| D: PEEP=12cmH2O | Experimental | Behavioral: lung recruitment maneuvre; PEEPBaseline respiratory mechanics parameters (driving pressure [DP], dynamic lung compliance [Cdyn]) and hemodynamic parameters (mean arterial pressure [MAP], SV, CO, CI) were recorded before ARM. Ten minutes after insufflation of the peritoneum with CO2 and positioning of the patient for surgery, an ARM was performed using the built-in protocol of the Mindray anesthesia machine, applying a continuous positive pressure of 30 cmH2O for 30 seconds. Immediately afterwards, the PEEP level was adjusted to 12 cmH2O. Respiratory and hemodynamic parameters were recorded at 5, 10, 15, 20, 25, 30, 35, and 40 minutes after ARM. The PEEP level was set back to 4 cmH2O forty minutes after ARM until the end of surgery. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ASA physical status classification: Ⅰ or Ⅱ or Ⅲ
- Adults aged 18 to 80 years, regardless of gender.
- Patients undergoing elective laparoscopic colorectal cancer surgery under general anesthesia.
- Patients who have provided written informed consent after understanding the study purpose, procedures, and potential risks.
Key exclusion criteria (3 listed)
- Recent thoracic surgery; radiographic evidence of pneumothorax, emphysema, or pulmonary bullae;
- Pulmonary diseases: asthma or severe obstructive ventilatory dysfunction; preoperative pulse oxygen saturation (SpO2) < 90% on room air or < 95% with supplemental oxygen; contraindications to ARMs (e.g., intracranial hypertension, hypovolemic shock, or right heart failure);
- severe cardiac disease (NYHA class III/IV, acute coronary syndrome, sustained ventricular tachycardia); concurrent participation in another trial; or refusal to provide informed consent
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 |
|---|---|---|
| lung recruitment maneuvre; PEEPAfter the patient enters the operating room, routine monitoring of ECG, non-invasive blood pressure, and SpO₂ is performed. Local anesthesia is used for radial artery puncture and catheterization to monitor invasive blood pressure. After 3 minutes of pre-oxygenation, tracheal intubation is performed with the following ventilation parameters: VT 6-8 ml/kg, FiO₂ 60%, RR 15 breaths/min, I/E 1:2, and PEEP 4 cmH₂O. Ten minutes after the establishment of pneumoperitoneum during surgery, baseline levels of respiratory mechanical parameters and hemodynamic variables are recorded. Subsequently, alveolar recruitment is performed at a pressure of 30 cmH₂O for 30 seconds. Immediately after recruitment, the PEEP level is adjusted according to the group. The changes in respiratory mechanics parameters and hemodynamic variables after recruitment are recorded. After the outcome indicators recover to the new baseline level, the PEEP is readjusted to 4 cmH₂O. | Behavioural | A: PEEP=0 cmH2O, B: PEEP=4cmH2O, C: PEEP=8cmH2O, D: PEEP=12cmH2O |
Primary outcome
the duration of improvement in lung compliance
Time frame: during the surgery
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 24 Mar 2026.
- Individual participant dataSharing planned: No
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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 lung recruitment maneuvre; PEEP in people with Dynamic Lung Compliance and Alveolar Recruitment Maneuver, run by Northern Jiangsu People's Hospital 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 4 inclusion and 3 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 24 Mar 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. Some participants in this study may receive a placebo. 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?
the duration of improvement in lung compliance (time frame: during the surgery). 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 24 Mar 2026.