Effects of Individualized PEEP Guided by Driving Pressure on Postoperative Atelectasis in Patients With Morbid Obesity
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorYongtao Sun
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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 design
Design model
Parallel
Treatments tested in this trial
Individualized PEEP group
Procedure/SurgeryIndividualized 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 group
Procedure/SurgeryAfter the same RM, PEEP is fixed at 8 cmH2O.
Treatment groups
52 Participants
are divided into 2 treatment groupsGroup A: Individualized PEEP groupExperimental treatment 1 intervention
Group B: Fixed PEEP groupOther 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
After 30 minutes of extubationSecondary 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.
Time frame
After 30 minutes of extubationSponsors and contacts
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Yongtao Sun
Lead sponsor
Qianfoshan Hospital
Sponsor institution
Source ClinicalTrials.gov