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Effect of Intraoperative Dynamic Compliance Guided Individualized Positive End-expiratory Pressure on Postoperative Atelectasis After Laparoscopic Bariatric Surgery

Effect of Intraoperative Dynamic Compliance Guided Individualized Positive End-expiratory Pressure on Postoperative Atelectasis After Laparoscopic Bariatric Surgery: a Single-center, Double-blind Randomized Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04169607
Enrollment
40
Registered
2019-11-20
Start date
2019-12-16
Completion date
2021-07-19
Last updated
2021-07-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Atelectasis

Keywords

lung protective ventilation strategy, individualized positive end-expiratory pressure, Laparoscopic bariatric surgery, Mechanical ventilation, Anesthetic management, Lung dynamic compliance, Postoperative Atelectasis

Brief summary

This study intends to explore the effect of dynamic compliance guided individualized positive end-expiratory pressure titration strategy on reducing the level of postoperative atelectasis in obese patient who have laparoscopic bariatric surgery.The results of the study are to assess the effects of this intervention on the incidence,duration of postoperative atelectasis and other complications including hypoxemia etc. after laparoscopic bariatric surgery.And reducing the burden of postoperative atelectasis on patients and their families, hospitals and public resources.

Interventions

Basic ventilation: Volume-controlled ventilation (VCV) mode with positive end-expiratory pressure (PEEP) of 8cm H2O after induction of anesthesia, Recruitment maneuver (RM): Pressure-controlled ventilation (PCV) mode increasing PEEP from 10 to 25cmH2O in step of 5cmH2O per 30s. PEEP-titration maneuver: ventilation parameters reset as basic ventilation with PEEP still 25cmH2O.Decrease PEEP to 5cmH2O in step of 2cmH2O per 10 respiratory cycles to confirm the highest dynamic lung compliance (Cdy). After titration: A new RM will be performed and the final PEEP will be the one related to highest Cdy plus 2cm H2O. Randomized after the second RM. Individualized PEEP arm: maintain individualized PEEP; PEEP8 arm: maintain a fixed PEEP of 8cm H2O. VCV with other ventilation parameters the same as basic ventilation until extubation . After discharged from postoperative anesthesia care unit (60 to 90 minutes after extubation): chest CT .

Sponsors

Xuzhou Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Bmi ≥ 35 kg/ m2 2. over 18 years old 3. elective laparoscopic bariatric surgery (gastric bypass or sleeve)

Exclusion criteria

1. ASA \>IV 2. Lung bullae 3. thoracic surgery history 4. quit smoking less than 1 week 5. chronic obstructive pulmonary disease requiring oxygen 6. congestive heart failure (New York Heart Association classification ≥ III) 7. planned to be transferred to intensive care unit after surgery 8. Patients participating in another interventional study 9. Refuse to sign the informed consent

Design outcomes

Primary

MeasureTime frameDescription
Percentage of postoperative atelectasis60-90 minutes after extubationThe amount of postoperative atelectasis, expressed as the percentage of lung tissue in CT.

Secondary

MeasureTime frameDescription
PaO2/FiO2 ratio1 day before surgery(baseline),5 minutes after anesthesia induction,1 hour after pneumoperitoneum,before extubation,30 minutes after extubationPaO2/FiO2 ratio
Quality of Recovery Score - 40 (QoR-40)1 day before surgery(baseline),1,2,7,30 days after surgeryQuality of recovery will be evaluated by Quality of Recovery 40 (QoR40),which assesses five dimensions of recovery (physical comfort,emotional state, physical independence , physiological support and pain ). Each item is rated on a five-point Likert scale: none of the time, some of the time, usually, most of the time, and all the time. The total score on the QoR40 ranges from 40 (poorest quality of recovery) to 200 (best quality of recovery).
Mini-Mental score examination (MMSE)1 day before surgery(baseline),1,2 days after surgeryMini-Mental score examination \[MMSE\] used for screening of dementia.The total score on the MMSE ranges from 0 (most severe dementia) to 24 (no dementia).
Postoperative Complication1,2,7 days after surgeryincluding pulmonary and other systematic postoperative complications
Mean arterial pressureevery 5minutes During Surgery;end of each step during RM and titration strategyMean arterial pressure = (systolic blood pressure + 2 × diastolic blood pressure) / 3(mmHg)
pulse oxygen24 hours after surgeryContinuous measurement of 24h pulse oxygen after surgery(%)
diastolic blood pressureevery 5minutes During Surgery;end of each step during RM and titration strategydiastolic blood pressure measured by invasive arterial blood pressure(mmHg)
heart rateevery 5minutes During Surgery;end of each step during RM and titration strategyheart rate per minute
dynamic complianceevery 5minutes During Surgery;end of each step during RM and titration strategytidal volume/(airway peak pressure - PEEP)(ml/cmH2O)
airway plateau pressureevery 5minutes During Surgery;end of each step during RM and titration strategyairway plateau pressure is directly showed in the screen of ventilator(cmH2O)
airway peak pressureevery 5minutes During Surgery;end of each step during RM and titration strategyairway peak pressure is directly showed in the screen of ventilator(cmH2O)
systolic blood pressureevery 5minutes During Surgery;end of each step during RM and titration strategysystolic blood pressure measured by invasive arterial blood pressure(mmHg)

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026