Effect of Intraoperative Dynamic Compliance Guided Individualized Positive End-expiratory Pressure on Postoperative Atelectasis After Laparoscopic Bariatric Surgery
- Conditions
- Postoperative Atelectasis
- Interventions
- Procedure: Dynamic compliance guided individualized positive end-expiratory pressure titration strategy
- Registration Number
- NCT04169607
- Lead Sponsor
- Xuzhou Medical University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
- Bmi ≥ 35 kg/ m2
- over 18 years old
- elective laparoscopic bariatric surgery (gastric bypass or sleeve)
- ASA >IV
- Lung bullae
- thoracic surgery history
- quit smoking less than 1 week
- chronic obstructive pulmonary disease requiring oxygen
- congestive heart failure (New York Heart Association classification ≥ III)
- planned to be transferred to intensive care unit after surgery
- Patients participating in another interventional study
- Refuse to sign the informed consent
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PEEP 8 Dynamic compliance guided individualized positive end-expiratory pressure titration strategy Bacis ventilation: Volume-controlled ventilation mode with positive end-expiratory pressure（PEEP） of 8cm H2O after induction of anesthesia， Recruitment maneuver: Pressure-controlled ventilation mode increasing PEEP from 10 to 25cmH2O. PEEP-titration maneuver: At this PEEP level, a decremental PEEP-titration maneuver will be started in volume-controlled ventilation mode, decreasing PEEP to 5cmH2O to confirm the highest dynamic lung compliance. After titration: A new recruitment maneuver will be performed and the final PEEP will be the one related to the highest dynamic lung compliance plus 2cm H2O. Randomization: Subsequently patient was randomized , the PEEP was then reduced to 8cm H2O (PEEP8 arm) until extubation. After discharged from post-anesthesia care unit (60 to 90 minutes after extubation)：A chest computerized tomography（CT） will be performed to assess the amount of atelectasis, expressed as the percentage of lung tissue in CT. individualized PEEP Dynamic compliance guided individualized positive end-expiratory pressure titration strategy Basic ventilation: Volume-controlled ventilation mode with positive end-expiratory pressure（PEEP） of 8cm H2O after induction of anesthesia， Recruitment maneuver: Pressure-controlled ventilation mode increasing PEEP from 10 to 25cmH2O. PEEP-titration maneuver: At this PEEP level, a decremental PEEP-titration maneuver will be started in volume-controlled ventilation mode, decreasing PEEP to 5cmH2O to confirm the highest dynamic lung compliance. After titration: A new recruitment maneuver will be performed and the final PEEP will be the one related to the highest dynamic lung compliance plus 2cm H2O. Randomization: Subsequently patient was randomized, the PEEP was then maintained (individualized PEEP arm) until extubation. After discharged from post-anesthesia care unit (60 to 90 minutes after extubation)：A chest computerized tomography（CT） will be performed to assess the amount of atelectasis, expressed as the percentage of lung tissue in CT.
- Primary Outcome Measures
Name Time Method Percentage of postoperative atelectasis 60-90 minutes after extubation The amount of postoperative atelectasis, expressed as the percentage of lung tissue in CT.
- Secondary Outcome Measures
Name Time Method pulse oxygen every 5minutes During Surgery；end of each step during RM and titration strategy pulse oxygen（%）
PaO2/FiO2 ratio 1 day before surgery(baseline)，5 minutes after anesthesia induction，1 hour after pneumoperitoneum，before extubation，30 minutes after extubation PaO2/FiO2 ratio
Postoperative Complication 1，2，7 days after surgery including pulmonary and other systematic postoperative complications
Quality of Recovery Score - 40 (QoR-40) 1 day before surgery(baseline)，1，2，7，30 days after surgery Quality 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 surgery Mini-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).
Mean arterial pressure every 5minutes During Surgery；end of each step during RM and titration strategy Mean arterial pressure = (systolic blood pressure + 2 × diastolic blood pressure) / 3（mmHg）
systolic blood pressure every 5minutes During Surgery；end of each step during RM and titration strategy systolic blood pressure measured by invasive arterial blood pressure（mmHg）
diastolic blood pressure every 5minutes During Surgery；end of each step during RM and titration strategy diastolic blood pressure measured by invasive arterial blood pressure（mmHg）
dynamic compliance every 5minutes During Surgery；end of each step during RM and titration strategy tidal volume/(airway peak pressure - PEEP)（ml/cmH2O）
airway plateau pressure every 5minutes During Surgery；end of each step during RM and titration strategy airway plateau pressure is directly showed in the screen of ventilator（cmH2O）
airway peak pressure every 5minutes During Surgery；end of each step during RM and titration strategy airway peak pressure is directly showed in the screen of ventilator（cmH2O）
heart rate every 5minutes During Surgery；end of each step during RM and titration strategy heart rate per minute
Trial Locations
- Locations (1)
Department of Anesthesia of the Affiliated Hospital of Xuzhou Medical University
🇨🇳Xuzhou, Jiangsu, China