Clinical trial NCT04169607: Effect of Intraoperative Dynamic Compliance Guided Individualized Positive End-expiratory Pressure on Postoperative Atelectasis After Laparoscopic Bariatric Surgery
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Xuzhou Medical University
Sponsor class: OTHER
First posted: 2019-11-20
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of postoperative atelectasis
timeFrame: 60-90 minutes after extubation
Secondary outcomes:
measure: pulse oxygen
timeFrame: 24 hours after surgery
measure: PaO2/FiO2 ratio
timeFrame: 1 day before surgery(baseline)，5 minutes after anesthesia induction，1 hour after pneumoperitoneum，before extubation，30 minutes after extubation
measure: Quality of Recovery Score - 40 (QoR-40)
timeFrame: 1 day before surgery(baseline)，1，2，7，30 days after surgery
measure: Mini-Mental score examination (MMSE)
timeFrame: 1 day before surgery(baseline)，1，2 days after surgery
measure: Postoperative Complication
timeFrame: 1，2，7 days after surgery
measure: Mean arterial pressure
timeFrame: every 5minutes During Surgery；end of each step during RM and titration strategy
measure: systolic blood pressure
timeFrame: every 5minutes During Surgery；end of each step during RM and titration strategy
measure: diastolic blood pressure
timeFrame: every 5minutes During Surgery；end of each step during RM and titration strategy
measure: heart rate
timeFrame: every 5minutes During Surgery；end of each step during RM and titration strategy
measure: pulse oxygen
timeFrame: every 5minutes During Surgery；end of each step during RM and titration strategy
measure: dynamic compliance
timeFrame: every 5minutes During Surgery；end of each step during RM and titration strategy
measure: airway plateau pressure
timeFrame: every 5minutes During Surgery；end of each step during RM and titration strategy
measure: airway peak pressure
timeFrame: every 5minutes During Surgery；end of each step during RM and titration strategy
Other outcomes:
Locations:
city: Xuzhou
country: China
facility: Department of Anesthesia of the Affiliated Hospital of Xuzhou Medical University
state: Jiangsu
Study officials:
References: