PostoperativePulmonaryComplicationsNCT06996288
A Multicenter Randomized Controlled Clinical Trial of the Impact of Minimally Invasive Abdominal Surgery Esophageal Pressure Monitoring Guided Individualized PEEP on Postoperative Pulmonary Complications in Obese Patients
A study testing Transpulmonary pressure-guided individualized PEEP in people with PostoperativePulmonaryComplications, run by Tianjin Medical University Cancer Institute and Hospital.
Trial summary
The aim of this study is to compare the effect of individualized PEEP based on transmural lung pressure and fixed PEEP on postoperative pulmonary complications during laparoscopic or robotic abdominal surgery in obese patients. The main questions are: 1. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- PostoperativePulmonaryComplications
- What is being tested?
- Transpulmonary pressure-guided individualized PEEP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- No sites listed yet
- Study dates
- 20 May 2025to 31 Dec 2027
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥18 years of age; ASA class I-III. Patients undergoing bariatric laparoscopic or robotic abdominal surgery; BMI ≥30 kg/m²; Planned operative time ≥120 minutes.
Who cannot join
- Presence of other serious cardiorespiratory diseases, such as severe chronic obstructive pulmonary disease (COPD, GOLD Class III-IV); history of severe or uncontrolled bronchial asthma, history of pulmonary resection; Presence of unstable cardiovascular disease, NYHA classification 3-4, such as severe arrhythmias or heart failure; Presence of neuromuscular disease affecting respiratory function, such as severe spinal cord injury; intracranial injury history of esophageal-related surgery, contraindications to esophageal catheter insertion, including severe coagulopathy (platelets < 5000/μL or INR > 4) severe chronic liver disease (Child-Pugh score ≥ 12) Patients who cannot be extubated in time after surgery and need to return to the ICU with an endotracheal tube or are scheduled to be reintubated after surgery.
- general anesthesia duration less than 120 minutes
About this study
The aim of this study is to compare the effect of individualized PEEP based on transmural lung pressure and fixed PEEP on postoperative pulmonary complications during laparoscopic or robotic abdominal surgery in obese patients.
The main questions are:
Read more
- whether the intraoperative application of individualized PEEP in obese patients can reduce the incidence of postoperative pulmonary complications at 7d, 30d, and 90d postoperatively compared to fixed PEEP
- Whether the application of individualized PEEP in obese patients can optimize intraoperative respiratory mechanics, oxygenation index (PaO2/FiO2), PaCO2, and EtCO2 compared with fixed PEEP.
3 Whether the application of individualized PEEP in obese patients can reduce the incidence of non-respiratory complications, postoperative QoR-15 scores, unplanned reintubation, unplanned transfers, and unplanned extubation in the postoperative period compared with fixed PEEP. planned reintubation, unplanned transfers to ICU and ICU days, hospitalization days, 30-day and 90-day mortality.
Participants will:
Patients with BMI >= 30 kg/m² undergoing laparoscopic or robotic abdominal surgery received PEEP during surgery (divided into individualized PEEP and fixed PEEP), and were followed up for 90 days to observe the incidence of pulmonary complications and related study outcomes.
- Conditions
- PostoperativePulmonaryComplications
- Being tested
- Transpulmonary pressure-guided individualized PEEP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transpulmonary pressure-guided individualized PEEPDevice
Transpulmonary pressure-guided individualized PEEP group was an intraoperative ventilation strategy based on esophageal pressure (Pes) monitoring of transpulmonary pressure-guided ventilation, using a small tidal volume (6-8 ml/kg of ideal body weight), maintaining the transpulmonary pressure in the safe range of 5-15 cmH2O PEEP for Pes+1 cm H2O level.
| Study group | Role | What they receive |
|---|---|---|
| Transpulmonary pressure-guided individualized PEEP group | Experimental | Preoperative assessment was performed based on basic information such as patient's age, height, weight, BMI classification, pulmonary function and blood gases. Intraoperatively, a ventilation strategy based on esophageal pressure (Pes) to monitor the transpulmonary pressure guidance was adopted, using a small tidal volume (6-8 ml/kg of ideal body weight), maintaining the transpulmonary pressure in the safe range of 5-15 cmH2O with PEEP at the level of Pes+1 cm H2O. Receives: Device: Transpulmonary pressure-guided individualized PEEP |
| The fixed PEEP | No intervention | The fixed PEEP group was the intraoperative ventilation strategy based on lung protection, using a small tidal volume (6-8 ml/kg of ideal body weight) and setting the PEEP level at 8 cmH2O. |
What is being measured
The primary outcome is the main question the study is designed to answer.
PostoperativePulmonaryComplications
The primary outcome was acomposite of pulmonary complications within the first 7 postoperative days, including respiratory failure, acute respiratory distress syndrome, bronchospasm, new pulmonaryinfiltrates, pulmonary infection, aspiration pneumonitis, pleural effusion, atelectasis, cardiopulmonary edema, and pneumothorax.
Measured: From enrollment to seven days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2025
- Study start20 May 2025 (estimated)
- Primary completion31 May 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PostoperativePulmonaryComplicationsStudies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and HospitalThe 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, Investigator
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06996288
- Sponsor's protocol ID
- E20241048A
- Other IDs
- E20241048A-1
- Status last verified
- Jan 2025
- First submitted
- 21 May 2025
- Last updated
- 30 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Randomized Controlled Clinical Trial of the Impact of Minimally Invasive Abdominal Surgery Esophageal Pressure Monitoring Guided Individualized PEEP on Postoperative Pulmonary Complications in Obese Patients
- ClinicalTrials.gov ID
- NCT06996288
- Acronym / sponsor ID
- E20241048A
- Conditions
- PostoperativePulmonaryComplications
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 20 May 2025 (estimated)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 30 May 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.
The aim of this study is to compare the effect of individualized PEEP based on transmural lung pressure and fixed PEEP on postoperative pulmonary complications during laparoscopic or robotic abdominal surgery in obese patients.
The main questions are:
- whether the intraoperative application of individualized PEEP in obese patients can reduce the incidence of postoperative pulmonary complications at 7d, 30d, and 90d postoperatively compared to fixed PEEP
- Whether the application of individualized PEEP in obese patients can optimize intraoperative respiratory mechanics, oxygenation index (PaO2/FiO2), PaCO2, and EtCO2 compared with fixed PEEP.
3 Whether the application of individualized PEEP in obese patients can reduce the incidence of non-respiratory complications, postoperative QoR-15 scores, unplanned reintubation, unplanned transfers, and unplanned extubation in the postoperative period compared with fixed PEEP. planned reintubation, unplanned transfers to ICU and ICU days, hospitalization days, 30-day and 90-day mortality.
Participants will:
Patients with BMI >= 30 kg/m² undergoing laparoscopic or robotic abdominal surgery received PEEP during surgery (divided into individualized PEEP and fixed PEEP), and were followed up for 90 days to observe the incidence of pulmonary complications and related study outcomes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transpulmonary pressure-guided individualized PEEP group | Experimental | Device: Transpulmonary pressure-guided individualized PEEPPreoperative assessment was performed based on basic information such as patient's age, height, weight, BMI classification, pulmonary function and blood gases. Intraoperatively, a ventilation strategy based on esophageal pressure (Pes) to monitor the transpulmonary pressure guidance was adopted, using a small tidal volume (6-8 ml/kg of ideal body weight), maintaining the transpulmonary pressure in the safe range of 5-15 cmH2O with PEEP at the level of Pes+1 cm H2O. |
| The fixed PEEP | No intervention | –The fixed PEEP group was the intraoperative ventilation strategy based on lung protection, using a small tidal volume (6-8 ml/kg of ideal body weight) and setting the PEEP level at 8 cmH2O. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ≥18 years of age; ASA class I-III. Patients undergoing bariatric laparoscopic or robotic abdominal surgery; BMI ≥30 kg/m²; Planned operative time ≥120 minutes.
Key exclusion criteria (2 listed)
- Presence of other serious cardiorespiratory diseases, such as severe chronic obstructive pulmonary disease (COPD, GOLD Class III-IV); history of severe or uncontrolled bronchial asthma, history of pulmonary resection; Presence of unstable cardiovascular disease, NYHA classification 3-4, such as severe arrhythmias or heart failure; Presence of neuromuscular disease affecting respiratory function, such as severe spinal cord injury; intracranial injury history of esophageal-related surgery, contraindications to esophageal catheter insertion, including severe coagulopathy (platelets < 5000/μL or INR > 4) severe chronic liver disease (Child-Pugh score ≥ 12) Patients who cannot be extubated in time after surgery and need to return to the ICU with an endotracheal tube or are scheduled to be reintubated after surgery.
- general anesthesia duration less than 120 minutes
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 |
|---|---|---|
| Transpulmonary pressure-guided individualized PEEPTranspulmonary pressure-guided individualized PEEP group was an intraoperative ventilation strategy based on esophageal pressure (Pes) monitoring of transpulmonary pressure-guided ventilation, using a small tidal volume (6-8 ml/kg of ideal body weight), maintaining the transpulmonary pressure in the safe range of 5-15 cmH2O PEEP for Pes+1 cm H2O level. | Device | Transpulmonary pressure-guided individualized PEEP group |
Primary outcome
PostoperativePulmonaryComplications
Time frame: From enrollment to seven days postoperatively
The primary outcome was acomposite of pulmonary complications within the first 7 postoperative days, including respiratory failure, acute respiratory distress syndrome, bronchospasm, new pulmonaryinfiltrates, pulmonary infection, aspiration pneumonitis, pleural effusion, atelectasis, cardiopulmonary edema, and pneumothorax.
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 30 May 2025.
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.
Questions about this trial
What is this clinical trial studying?
A study testing Transpulmonary pressure-guided individualized PEEP in people with PostoperativePulmonaryComplications, run by Tianjin Medical University Cancer Institute and Hospital.
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 1 inclusion and 2 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: opening soon, as of the sponsor's last update on 30 May 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
PostoperativePulmonaryComplications (time frame: From enrollment to seven days postoperatively). 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 30 May 2025.