Minimizing Lung Injury During Laparoscopy in Steep Trendelenburg Position

NCT04900714 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2022-01-26

No results posted yet for this study

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

Conditions

  • Atelectasis

Interventions

PROCEDURE

Decremental PEEP

High PEEP to low PEEP.

DIAGNOSTIC_TEST

Lung ultrasound score

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

DIAGNOSTIC_TEST

Blood gas analysis

Blood gas analysis to determine arterial oxygen tension

DIAGNOSTIC_TEST

Registration of respiratory mechanics

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

DIAGNOSTIC_TEST

Evaluation of dead space

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

Sponsors & Collaborators

  • University Hospital, Antwerp

    lead OTHER

Principal Investigators

  • Vera Saldien, MD, PhD · Head of the department of anesthesiology

  • Tom Schepens, MD, PhD · Anesthetist/intensivist

  • Gregory De Meyer, MD · Anesthetist in training

  • Stuart G Morrison, MD · Staff anesthetist

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-06-21
Primary Completion
2021-09-23
Completion
2021-09-23

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04900714 on ClinicalTrials.gov