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

Postoperative Atelectasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04169607
• Other study ID #: XYFY2019-KL168-01
• Status: Completed
• Phase: N/A
• Start date: December 16, 2019
• Est. completion date: July 19, 2021

Study information

• Verified date: July 2021
• Source: Xuzhou Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 19, 2021
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Postoperative Atelectasis
• Pulmonary Atelectasis

Intervention

Procedure:
• Dynamic compliance guided individualized positive end-expiratory pressure titration strategy
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 .

Locations

Country	Name	City	State
China	Department of Anesthesia of the Affiliated Hospital of Xuzhou Medical University	Xuzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Xuzhou Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of postoperative atelectasis	The amount of postoperative atelectasis, expressed as the percentage of lung tissue in CT.	60-90 minutes after extubation
Secondary	pulse oxygen	Continuous measurement of 24h pulse oxygen after surgery(%)	24 hours after surgery
Secondary	PaO2/FiO2 ratio	PaO2/FiO2 ratio	1 day before surgery(baseline),5 minutes after anesthesia induction,1 hour after pneumoperitoneum,before extubation,30 minutes after extubation
Secondary	Quality of Recovery Score - 40 (QoR-40)	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).	1 day before surgery(baseline),1,2,7,30 days after surgery
Secondary	Mini-Mental score examination (MMSE)	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).	1 day before surgery(baseline),1,2 days after surgery
Secondary	Postoperative Complication	including pulmonary and other systematic postoperative complications	1,2,7 days after surgery
Secondary	Mean arterial pressure	Mean arterial pressure = (systolic blood pressure + 2 × diastolic blood pressure) / 3(mmHg)	every 5minutes During Surgery;end of each step during RM and titration strategy
Secondary	systolic blood pressure	systolic blood pressure measured by invasive arterial blood pressure(mmHg)	every 5minutes During Surgery;end of each step during RM and titration strategy
Secondary	diastolic blood pressure	diastolic blood pressure measured by invasive arterial blood pressure(mmHg)	every 5minutes During Surgery;end of each step during RM and titration strategy
Secondary	heart rate	heart rate per minute	every 5minutes During Surgery;end of each step during RM and titration strategy
Secondary	pulse oxygen	pulse oxygen(%)	every 5minutes During Surgery;end of each step during RM and titration strategy
Secondary	dynamic compliance	tidal volume/(airway peak pressure - PEEP)(ml/cmH2O)	every 5minutes During Surgery;end of each step during RM and titration strategy
Secondary	airway plateau pressure	airway plateau pressure is directly showed in the screen of ventilator(cmH2O)	every 5minutes During Surgery;end of each step during RM and titration strategy
Secondary	airway peak pressure	airway peak pressure is directly showed in the screen of ventilator(cmH2O)	every 5minutes During Surgery;end of each step during RM and titration strategy