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

NCT04327193 | Completed DMC

• 1 other identifier: SYoon_DP_RALP
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Atelectasis, Postoperative Pulmonary

Keywords

Driving pressure; Positive end-expiratory pressure; Lung ultrasound

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Modified lung ultrasound score

  Intraoperative (at the end of operation before emergence)

• Incidence of intraoperative desaturation

  Intraoperative

• Intraoperative 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

  30 minutes after PACU administration

• Postoperative pulmonary complications

  After operation~ postoperative day 3

Study Arms (2)

Driving pressure

EXPERIMENTAL

The selected PEEP which makes the driving pressure lowest is applied during the operation.

Procedure: Titrated PEEP based on driving pressure

Conventional

ACTIVE COMPARATOR

Conventional PEEP (5cmH2O) is applied.

Procedure: Conventional PEEP

Interventions

Titrated PEEP based on driving pressure PROCEDURE

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.

Driving pressure

Conventional PEEP PROCEDURE

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.

Conventional

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing robot-assisted laparoscopic prostatectomy with Trendelenburg position

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, Jongnogu, 03080, South Korea

Location

MeSH Terms

Conditions

Pulmonary Atelectasis

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Study Officials

• Susie Yoon, MD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: March 26, 2020
• First Posted: March 31, 2020
• Study Start: May 4, 2020
• Primary Completion: October 6, 2020
• Study Completion: October 6, 2020
• Last Updated: October 15, 2021

Record last verified: 2021-10

Locations

KR (1)