NCT04900714

Brief Summary

The investigators hypothesize that the level of PEEP is often suboptimally applied in certain operative conditions, such as in laparoscopy with head down (Trendelenburg) positioning. This can result in excessive levels of lung stress and postoperative pulmonary complications. In patients with steep Trendelenburg and a pneumoperitoneum, the investigators aim to

  1. 1.measure apical versus basal atelectasis using the lung ultrasound score
  2. 2.compare lung ultrasound scores at different PEEP levels
  3. 3.compare respiratory mechanics at the different PEEP levels
  4. 4.contrast the optimal PEEP level to standard practice
  5. 5.provide guidance to optimal PEEP titration in this setting for the clinician

Trial Health

87
On Track

Trial Health Score

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

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2021

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

September 24, 2020

Completed
8 months until next milestone

First Posted

Study publicly available on registry

May 25, 2021

Completed
27 days until next milestone

Study Start

First participant enrolled

June 21, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 23, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 23, 2021

Completed
Last Updated

January 26, 2022

Status Verified

January 1, 2022

Enrollment Period

3 months

First QC Date

September 24, 2020

Last Update Submit

January 25, 2022

Conditions

Atelectasis

Keywords

Positive-Pressure RespirationRespiratory Mechanicspositive end-expiratory pressure

Outcome Measures

Primary Outcomes (1)

  • Lung ultrasound score

    Lung ultrasound score per level of PEEP (15-10-5-0 cmH2O). The score is dimensionless. A cumulative count is calculated for each level of PEEP by adding the scores from the 6 scanned lung regions together. The lung ultrasound score is a measure of atelectasis.

    Perioperatively

Secondary Outcomes (5)

  • Transpulmonary pressure (cmH2O)

    Perioperatively

  • Driving pressure (cmH2O)

    Perioperatively

  • Dynamic pulmonary compliance (ml/cmH2O)

    Perioperatively

  • P/F ratio (Horowitz index, mmHg / %)

    Perioperatively

  • Dead space

    Perioperatively

Study Arms (1)

Decremental PEEP

EXPERIMENTAL

Every participant will be exposed to a stepwise decremental PEEP.

Procedure: Decremental PEEPDiagnostic Test: Lung ultrasound scoreDiagnostic Test: Blood gas analysisDiagnostic Test: Registration of respiratory mechanicsDiagnostic Test: Evaluation of dead space

Interventions

Decremental PEEPPROCEDURE

High PEEP to low PEEP.

Decremental PEEP
Lung ultrasound scoreDIAGNOSTIC_TEST

lung ultrasound to determine the extend of atelectasis. Uses validated lung ultrasound score.

Decremental PEEP
Blood gas analysisDIAGNOSTIC_TEST

Blood gas analysis to determine arterial oxygen tension

Decremental PEEP
Registration of respiratory mechanicsDIAGNOSTIC_TEST

Pressures and volumes will be registered by the Fluxmed respiratory monitor (MBMED, Argentina)

Decremental PEEP
Evaluation of dead spaceDIAGNOSTIC_TEST

Dead space will be measured non-invasively using volumetric capnography on the FluxMed respiratory monitor (MBMED, Argentina)

Decremental PEEP

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Elective laparoscopy in the Trendelenburg (head-down) position

You may not qualify if:

  • smoker
  • lung disease (e.g. asthma, COPD, emphysema)
  • BMI \> 30 kg/m2

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Antwerp University Hospital

Edegem, Antwerp, 2650, Belgium

Location

Related Publications (1)

  • De Meyer GRA, Morrison SG, Saldien V, Jorens PG, Schepens T. Minimizing Lung Injury During Laparoscopy in Head-Down Tilt: A Physiological Cohort Study. Anesth Analg. 2023 Oct 1;137(4):841-849. doi: 10.1213/ANE.0000000000006325. Epub 2022 Dec 14.

    PMID: 36729514DERIVED

MeSH Terms

Conditions

Pulmonary Atelectasis

Interventions

Blood Gas Analysis

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical AnalysisClinical Chemistry TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisRespiratory Function TestsDiagnostic Techniques, Respiratory SystemInvestigative Techniques

Study Officials

  • Vera Saldien, MD, PhD

    Head of the department of anesthesiology

    PRINCIPAL INVESTIGATOR

  • Tom Schepens, MD, PhD

    Anesthetist/intensivist

    STUDY CHAIR

  • Gregory De Meyer, MD

    Anesthetist in training

    STUDY CHAIR

  • Stuart G Morrison, MD

    Staff anesthetist

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 24, 2020

First Posted

May 25, 2021

Study Start

June 21, 2021

Primary Completion

September 23, 2021

Study Completion

September 23, 2021

Last Updated

January 26, 2022

Record last verified: 2022-01

Locations

BE(1)