Pulmonary AtelectasisNCT06181279
Effects of Individualized PEEP Guided by Driving Pressure on Postoperative Atelectasis in Patients With Morbid Obesity
A study testing Individualized PEEP group and Fixed PEEP group in people with Pulmonary Atelectasis and Obesity, Morbid, run by Yongtao Sun at 1 site in China.
Trial summary
Atelectasis is a common complication in patients undergoing surgery under general anesthesia, particularly in obese patients. Postoperative atelectasis could last for more than 24h and contribute to a variety of other complications, including hypoxemia and pneumonia. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Pulmonary Atelectasis, Obesity, Morbid
- What is being tested?
- Individualized PEEP group and Fixed PEEP group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2024to 31 Dec 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18 to 60 years old;
- Body mass index (BMI) ≥ 40 kg/m2;
- ASA classification I to III;
- Signing the informed consent form for this clinical study;
Who cannot join
- Respiratory infection within 4 weeks; severe respiratory system diseases; history of pulmonary and/or thoracic surgery; neuromuscular dysfunction;
- Serious cardiac, renal or haematopoietic diseases;
- Contraindications to PEEP；
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Qianfoshan Hospital, The First Hospital affiliated of Shandong First Medical University
Jinan, Shandong, 250014
yong T Sun, PH.D, 18660795201, sunyongtao1979@163.com
About this study
Official title: Effects of Individualized Positive End-expiratory Pressure Guided by Driving Pressure on Postoperative Atelectasis After Bariatric Surgery in Patients With Morbid Obesity: A Single-center, Prospective, Randomized Controlled Study
Atelectasis is a common complication in patients undergoing surgery under general anesthesia, particularly in obese patients. Postoperative atelectasis could last for more than 24h and contribute to a variety of other complications, including hypoxemia and pneumonia. We plan to conduct a single-center, randomized controlled trial in patients undergoing bariatric surgery to test the hypothesis that driving pressure guided PEEP could reduce the postoperative atelectasis.
Read the detailed description
Positive end-expiratory pressure (PEEP) is a strategy that helps to keep alveoli open during surgery and to prevent postoperative atelectasis. A fixed PEEP without considering the respiratory mechanics in individual patients, however, is not optimal. Individualized PEEP therefore has been increasingly studied, and has been shown to improve oxygenation in both nonobese and obese patients. Studies have shown that the occurrence and prognosis of PPCs are significantly associated with high driving pressure (DP), but not with VT and PEEP. Driving pressure-guided individualized PEEP is expected to be a novel perioperative lung protection strategy. Consequently, the main aim of this study is to investigate the effect of a driving pressure-guided individualized PEEP ventilation strategy on postoperative pulmonary atelectasis in morbidly obese patients undergoing bariatric surgery.
- Conditions
- Pulmonary Atelectasis, Obesity, Morbid
- Being tested
- Individualized PEEP group, Fixed PEEP group
- Keywords
- Individual Positive End-expiratory Pressure, Driving Pressure, Ventilator-induced Lung Injury
- Medical subject headings
- Pulmonary Atelectasis, Obesity, Morbid, Ventilator-Induced Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individualized PEEP groupProcedure or surgery
Individualized PEEP group: Recruitment Maneuver (RM) is performed first. In pressure control mode, PEEP and airway plateau pressure are increased to 20 cmH2O and 35 cmH2O at a rate of 5 cmH2O every 30s, and driving pressure is maintained at 15 cmH2O throughout. Subsequently, in volume-controlled ventilation mode, PEEP decreases from 20 cmH2O to 4 cmH2O at gradient of 2 cmH2O, and each PEEP level is maintained for 30s. The PEEP corresponding to the lowest driving pressure is the individualized PEEP we need. If multiple PEEP levels showed the same lowest driving pressure, the lowest PEEP value as the individualized PEEP. The above procedures are performed three times during the surgery (5 minutes after intubation,5 minutes after the beginning of pneumoperitoneum, and 5 minutes after the end of pneumoperitoneum).
Fixed PEEP groupProcedure or surgery
After the same RM, PEEP is fixed at 8 cmH2O.
| Study group | Role | What they receive |
|---|---|---|
| Individualized PEEP group | Experimental | After recruitment maneuver, PEEP is titrated decreasingly using driving pressure guided individualised PEEP ventilation strategy, and the PEEP corresponding to the lowest driving pressure is the individualised PEEP. Receives: Procedure: Individualized PEEP group |
| Fixed PEEP group | Other | After recruitment maneuver, PEEP is fixed at 8cmH2O. Receives: Procedure: Fixed PEEP group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of postoperative pulmonary atelectasis
The primary outcome of this study is postoperative atelectasis measured by lung ultrasound. Each hemithorax is divided into 6 regions using 3 longitudinal lines (parasternal, anterior and posterior axillary)and 2 axial lines (one above the diaphragm and the other 1 cm above the nipples). The 12 lung regions were scanned sequentially from right to left, cranial to caudal and anterior to posterior. Each region is assessed using a 2-dimen-sional view with the probe placed parallel to the ribs. It distinguishes four progressive steps of loss of aeration according to the artifacts visualized in a scan: score 0, normal aeration (A-lines or no more than two B-lines); score 1, moderate loss of aeration (three or more well-spaced B-lines); score 2, severe loss of aeration(coalescent B-lines); and score 3, complete loss of aeration(tissue-like pattern). We define atelectasis to be significant if any region had a lung consolidation score of ≥2.
Measured: After 30 minutes of extubation
Secondary outcomes (1)
Postoperative pulmonary ultrasound score
Each hemithorax is divided into 6 regions using 3 longitudinal lines (parasternal, anterior and posterior axillary)and 2 axial lines (one above the diaphragm and the other 1 cm above the nipples). The 12 lung regions were scanned sequentially from right to left, cranial to caudal and anterior to posterior. Each region is assessed using a 2-dimen-sional view with the probe placed parallel to the ribs. It distinguishes four progressive steps of loss of aeration according to the artifacts visualized in a scan: score 0, normal aeration (A-lines or no more than two B-lines); score 1, moderate loss of aeration (three or more well-spaced B-lines); score 2, severe loss of aeration(coalescent B-lines); and score 3, complete loss of aeration(tissue-like pattern). We define atelectasis to be significant if any region had a lung consolidation score of ≥2. Based upon the LUS scoring system, each area is scored from 0-3, so a minimum zero or maximum 36 score is possible.
Measured: After 30 minutes of extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2023
- Study start1 Mar 2024
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary AtelectasisStudies 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
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yongtao Sun
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yongtao Sun, Qianfoshan Hospital
- Investigators
- yong t Sun, Ph.D, Study chair, Shandong First Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06181279
- Sponsor's protocol ID
- DP guided PEEP
- Status last verified
- Jun 2024
- First submitted
- 12 Dec 2023
- Last updated
- 4 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ren Y, Sun YT, Zhang P, Chen L, Liu P, Zhou Z, Wang Y. Effect of driving pressure-guided individualised positive end-expiratory pressure on postoperative atelectasis in patients with morbid obesity: study protocol of a randomised controlled trial. BMJ Open. 2025 Mar 6;15(3):e091217. doi: 10.1136/bmjopen-2024-091217.
PubMed 40050061
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Individualized Positive End-expiratory Pressure Guided by Driving Pressure on Postoperative Atelectasis After Bariatric Surgery in Patients With Morbid Obesity: A Single-center, Prospective, Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06181279
- Acronym / sponsor ID
- DP guided PEEP
- Conditions
- Pulmonary Atelectasis, Obesity, Morbid
- Keywords
- Individual Positive End-expiratory Pressure, Driving Pressure, Ventilator-induced Lung Injury
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Yongtao SunUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 26 Dec 2023 (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.
Atelectasis is a common complication in patients undergoing surgery under general anesthesia, particularly in obese patients. Postoperative atelectasis could last for more than 24h and contribute to a variety of other complications, including hypoxemia and pneumonia. We plan to conduct a single-center, randomized controlled trial in patients undergoing bariatric surgery to test the hypothesis that driving pressure guided PEEP could reduce the postoperative atelectasis.
Detailed description
Positive end-expiratory pressure (PEEP) is a strategy that helps to keep alveoli open during surgery and to prevent postoperative atelectasis. A fixed PEEP without considering the respiratory mechanics in individual patients, however, is not optimal. Individualized PEEP therefore has been increasingly studied, and has been shown to improve oxygenation in both nonobese and obese patients. Studies have shown that the occurrence and prognosis of PPCs are significantly associated with high driving pressure (DP), but not with VT and PEEP. Driving pressure-guided individualized PEEP is expected to be a novel perioperative lung protection strategy. Consequently, the main aim of this study is to investigate the effect of a driving pressure-guided individualized PEEP ventilation strategy on postoperative pulmonary atelectasis in morbidly obese patients undergoing bariatric surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Individualized PEEP group | Experimental | Procedure: Individualized PEEP groupAfter recruitment maneuver, PEEP is titrated decreasingly using driving pressure guided individualised PEEP ventilation strategy, and the PEEP corresponding to the lowest driving pressure is the individualised PEEP. |
| Fixed PEEP group | Other | Procedure: Fixed PEEP groupAfter recruitment maneuver, PEEP is fixed at 8cmH2O. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age 18 to 60 years old;
- Body mass index (BMI) ≥ 40 kg/m2;
- ASA classification I to III;
- Signing the informed consent form for this clinical study;
Key exclusion criteria (3 listed)
- Respiratory infection within 4 weeks; severe respiratory system diseases; history of pulmonary and/or thoracic surgery; neuromuscular dysfunction;
- Serious cardiac, renal or haematopoietic diseases;
- Contraindications to PEEP；
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 |
|---|---|---|
| Individualized PEEP groupIndividualized PEEP group: Recruitment Maneuver (RM) is performed first. In pressure control mode, PEEP and airway plateau pressure are increased to 20 cmH2O and 35 cmH2O at a rate of 5 cmH2O every 30s, and driving pressure is maintained at 15 cmH2O throughout. Subsequently, in volume-controlled ventilation mode, PEEP decreases from 20 cmH2O to 4 cmH2O at gradient of 2 cmH2O, and each PEEP level is maintained for 30s. The PEEP corresponding to the lowest driving pressure is the individualized PEEP we need. If multiple PEEP levels showed the same lowest driving pressure, the lowest PEEP value as the individualized PEEP. The above procedures are performed three times during the surgery (5 minutes after intubation,5 minutes after the beginning of pneumoperitoneum, and 5 minutes after the end of pneumoperitoneum). | Procedure or surgery | Individualized PEEP group |
| Fixed PEEP groupAfter the same RM, PEEP is fixed at 8 cmH2O. | Procedure or surgery | Fixed PEEP group |
Primary outcome
Incidence of postoperative pulmonary atelectasis
Time frame: After 30 minutes of extubation
The primary outcome of this study is postoperative atelectasis measured by lung ultrasound. Each hemithorax is divided into 6 regions using 3 longitudinal lines (parasternal, anterior and posterior axillary)and 2 axial lines (one above the diaphragm and the other 1 cm above the nipples). The 12 lung regions were scanned sequentially from right to left, cranial to caudal and anterior to posterior. Each region is assessed using a 2-dimen-sional view with the probe placed parallel to the ribs. It distinguishes four progressive steps of loss of aeration according to the artifacts visualized in a scan: score 0, normal aeration (A-lines or no more than two B-lines); score 1, moderate loss of aeration (three or more well-spaced B-lines); score 2, severe loss of aeration(coalescent B-lines); and score 3, complete loss of aeration(tissue-like pattern). We define atelectasis to be significant if any region had a lung consolidation score of ≥2.
1 secondary outcome
Postoperative pulmonary ultrasound score
Time frame: After 30 minutes of extubation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2024.
- Derived from this study: PubMed 40050061Ren Y, Sun YT, Zhang P, Chen L, Liu P, Zhou Z, Wang Y. Effect of driving pressure-guided individualised positive end-expiratory pressure on postoperative atelectasis in patients with morbid obesity: study protocol of a randomised controlled trial. BMJ Open. 2025 Mar 6;15(3):e091217. doi: 10.1136/bmjopen-2024-091217.
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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.
yong t Sun, Ph.D study chair
Shandong First Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individualized PEEP group and Fixed PEEP group in people with Pulmonary Atelectasis and Obesity, Morbid, run by Yongtao Sun 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: status not confirmed, as of the sponsor's last update on 4 Jun 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact yong t Sun, Ph.D (18660795201, sunyongtao1979@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of postoperative pulmonary atelectasis (time frame: After 30 minutes of extubation). 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 NCT06181279, which also lists 1 linked publication.
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 4 Jun 2024.