Ignite Creation Date:
2024-05-06 @ 7:50 PM
Last Modification Date:
2024-10-26 @ 3:14 PM
Study NCT ID:
NCT06150079
Status:
RECRUITING
Last Update Posted:
2024-05-28
First Post:
2023-11-11
Brief Title:
Individualized PEEP Titration on Postoperative Pulmonary Complications
Sponsor:
Shanghai Zhongshan Hospital
Organization:
Shanghai Zhongshan Hospital
Study Overview
Official Title:
Effect of Individualized PEEP Titration on Postoperative Pulmonary Complications in Elderly Patients Undergoing Laparoscopic Surgery- A Multicenter Randomized Controlled Clinical Trial
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study aims to investigate the effectiveness and safety of implementing a personalized positive end-expiratory pressure PEEP management strategy guided by esophageal pressure Pes as well as its potential to reduce the occurrence of postoperative pulmonary complications PPCs in elderly patients undergoing laparoscopic surgery
Detailed Description:
This trial is a single-blind randomized controlled multicenter study Elderly patients undergoing laparoscopic surgery under general anesthesia will be recruited according the inclusion and exclusion criteria Participants in this study will be randomly assigned into two groups The total sample size will be 232 with 116 participants in the experimental group and 116 participants in the control group A stratified block randomization method will be employed using the ARISCAT score for PPCs risk assessment and individual study centers as stratification factors Anesthesia routine will be applied during pre-anesthetic preparation anesthetic induction maintenance and emergence except intraoperative respiratory management In the control group PEEP Group fixed PEEP of 3 cmH2O is applied throughout the procedure without lung recruitment maneuvers While in the experimental group Pes-Guided PEEP Group continuous monitoring of end-expiratory esophageal pressure Pes_ee is conducted PEEP is chosen to maintain a positive transpulmonary pressure at end-expiration Ptp_ee PEEP - Pes_ee after lung recruitment PEEP titration following lung recruitment should be performed after endotracheal intubation or any procedure that may cause lung collapse such as pneumoperitoneum deflation or inflation of the endotracheal tube cuff changes in position or endotracheal suctioning PEEP Titration is also required every hour after the establishment of pneumoperitoneum Patients will be followed up within 7 days after surgery to assess basic vital signs potential postoperative pulmonary complications PPCs Additionally postoperative non-respiratory complications will be evaluatedLaboratory tests the 15-item Quality of Recovery-15 QoR-15 questionnaire complications within 30 days after surgery and 90-day survival rates will also be recorded
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None