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

The Effectiveness of Driving Pressure Based Ventilation Strategy in Robot-assisted Laparoscopic Surgeries With Steep Trendelenburg Position: a Randomized Controlled Trial

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

Study Overview

• Status: Completed
• Conditions: Atelectasis, Postoperative Pulmonary
• Intervention / Treatment: Procedure: Titrated PEEP based on driving pressure; Procedure: Conventional PEEP

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Jongnogu
    • Seoul, Jongnogu, Korea, Republic of, 03080
      • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Driving pressure; The selected PEEP which makes the driving pressure lowest is applied during the operation.	Procedure: Titrated PEEP based on driving pressure; Alveolar recruitment and PEEP titration is performed at three time points: after intubation, after Trendelenburg, and after supine after CO2 deflation. The level of PEEP which makes the driving pressure lowest is selected and applied during the operation.
Active Comparator: Conventional; Conventional PEEP (5cmH2O) is applied.	Procedure: Conventional PEEP; Alveolar recruitment is performed at three time points: after intubation, after Trendelenburg, and after supine after CO2 deflation. Conventional PEEP (5cmH2O) is applied during the operation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modified lung ultrasound score	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.	30 minutes after PACU administration

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modified lung ultrasound score	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.	Intraoperative (at the end of operation before emergence)
Incidence of intraoperative desaturation	Oxygen saturation by pulse oximetry< 95%	Intraoperative
Intraoperative partial pressure of arterial oxygen/fraction of inspired oxygen ratio	Partial pressure of arterial oxygen/fraction of inspired oxygen ratio	Intraoperative (30 minutes after designated PEEP applied)
Postoperative partial pressure of arterial oxygen/fraction of inspired oxygen ratio	Partial pressure of arterial oxygen/fraction of inspired oxygen ratio	30 minutes after PACU administration
Postoperative pulmonary complications	Extubation failure, Fever, respiratory infection, respiratory failure, pleural effusion, atelectasis, pneumothorax, bronchospasm, aspiration pneumonitis, pneumonia	After operation~ postoperative day 3

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Investigators: Principal Investigator: Susie Yoon, MD, Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 4, 2020
• Primary Completion (Actual): October 6, 2020
• Study Completion (Actual): October 6, 2020

Study Registration Dates

• First Submitted: March 26, 2020
• First Submitted That Met QC Criteria: March 26, 2020
• First Posted (Actual): March 31, 2020

Study Record Updates

• Last Update Posted (Actual): October 15, 2021
• Last Update Submitted That Met QC Criteria: October 14, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Lung ultrasound; Positive end-expiratory pressure; Driving pressure
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Pulmonary Atelectasis
• Other Study ID Numbers: SYoon_DP_RALP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No