Driving Pressure-guided PEEP Titration in Robot-assisted Laparoscopic Surgeries

Not Applicable

Completed

• Conditions: Atelectasis, Postoperative Pulmonary
• Interventions: Procedure: Titrated PEEP based on driving pressure; Procedure: Conventional PEEP

• Registration Number: NCT04327193
• Lead Sponsor: Seoul National University Hospital

Brief Summary

The purpose of this study is to investigate the effect of driving-pressure guided positive end-expiratory pressure (PEEP) titration.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-03-26
• Study First Submitted QC: 2020-03-26
• Study First Posted: 2020-03-31
• Study Start: 2020-05-04
• Primary Completion: 2020-10-06
• Study Completion: 2020-10-06
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-14
• Last Update Posted: 2021-10-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

• Patients undergoing robot-assisted laparoscopic prostatectomy with Trendelenburg position

Exclusion Criteria

• American Society of Anesthesiologists physical status IV or more
• Severe cardiovascular disease
• Severe chronic obstructive pulmonary disease, emphysema
• History of pneumothorax, bullae
• History of lung resection surgery
• Conversion to laparotomy
• Refusal to participate

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Driving pressure	Titrated PEEP based on driving pressure	The selected PEEP which makes the driving pressure lowest is applied during the operation.
Conventional	Conventional PEEP	Conventional PEEP (5cmH2O) is applied.

Primary Outcome Measures

Name	Time	Method
Modified lung ultrasound score	30 minutes after PACU administration	The score is calculated by adding up the 12 individual part scores assessed using lung ultrasound. The score for each part ranges from 0 to 3.

Secondary Outcome Measures

Name	Time	Method
Postoperative partial pressure of arterial oxygen/fraction of inspired oxygen ratio	30 minutes after PACU administration	Partial pressure of arterial oxygen/fraction of inspired oxygen ratio
Incidence of intraoperative desaturation	Intraoperative	Oxygen saturation by pulse oximetry\< 95%
Intraoperative partial pressure of arterial oxygen/fraction of inspired oxygen ratio	Intraoperative (30 minutes after designated PEEP applied)	Partial pressure of arterial oxygen/fraction of inspired oxygen ratio
Modified lung ultrasound score	Intraoperative (at the end of operation before emergence)	The score is calculated by adding up the 12 individual part scores assessed using lung ultrasound. The score for each part ranges from 0 to 3.
Postoperative pulmonary complications	After operation~ postoperative day 3	Extubation failure, Fever, respiratory infection, respiratory failure, pleural effusion, atelectasis, pneumothorax, bronchospasm, aspiration pneumonitis, pneumonia

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Jongnogu, Korea, Republic of