NCT04327193

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 26, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 31, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

May 4, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 6, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 6, 2020

Completed
Last Updated

October 15, 2021

Status Verified

October 1, 2021

Enrollment Period

5 months

First QC Date

March 26, 2020

Last Update Submit

October 14, 2021

Conditions

Atelectasis, Postoperative Pulmonary

Keywords

Driving pressurePositive end-expiratory pressureLung 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 pressurePROCEDURE

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 PEEPPROCEDURE

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

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, Jongnogu, 03080, South Korea

Location

MeSH Terms

Conditions

Pulmonary Atelectasis

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory 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)