NCT02881814: US-ADEPT

UltraSound for Accurate Decisions in Chest PhysioTherapy

Status unknown NA Last updated 13 September 2023

What this trial tests

NA trial testing Lung and diaphragm ultrasound in Critical Illness in 153 participants. Status unknown.

Timeline

2 May 2017

Primary endpoint
18 November 2020

14 April 2024

Quick facts

Lead sponsor	Fondation Hôpital Saint-Joseph
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	153
Start date	2 May 2017
Primary completion	18 November 2020
Estimated completion	14 April 2024
Sites	4 locations across France, Australia

Drugs / interventions tested

• Lung and diaphragm ultrasound
• Lung and diaphragm ultrasound in MV patients

Conditions studied

• Critical Illness — all drugs for Critical Illness →
• Respiratory Disease — all drugs for Respiratory Disease →

Sponsor

Fondation Hôpital Saint-Joseph — full company profile →

Who can join

18 and older, any sex, with Critical Illness or Respiratory Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Introduction: Physiotherapist usually uses a clinical examination, including auscultation, an analysis of blood gasses and chest imaging to determine the indication for chest physiotherapy, to choose the treatment protocol and evaluate the efficacy of the management. Lung ultrasound (LUS) presents greater accuracy than chest X-ray in the diagnosis of lung deficiencies interesting the physiotherapist. So, it could allow the physiotherapist to determine the indication for chest physiotherapy and thus avoid unnecessary or inappropriate treatments. No study has evaluated the impact of LUS on clinical decisions in chest physiotherapy in ICU patients.

Objective: To evaluate the impact of using the results of lung and diaphragm US on clinical decisions in chest physiotherapy in hypoxemic patients hospitalized in ICU.

Method: The physiotherapist carries out a clinical examination and analyses the complementary tests (chest X-ray, chest CT-scan and blood gasses if available). Following the examination, he will put forward one or several hypotheses concerning the respiratory deficiency and will confirm or not the indication for chest physiotherapy. If respiratory physiotherapy is indicated, the physiotherapist will specify the protocol.

A lung and diaphragm US will be done following the evaluation of the clinical physiotherapist, and will make it possible to answer the question: are the results of the lung and diaphragm US compatible with the hypotheses put forward? The LUS report will be given to the clinical physiotherapist. He will specify the respiratory physiotherapy protocol according to the results of the US-scan.

The modification of the clinical decision will be assessed with the Net Reclassification Index (NRI).

Expected results: We expect that decisions for chest physiotherapy will be modified by LUS. The expected benefit for patients is therefore that they will be given a chest physiotherapy protocol that is better suited to the type of respiratory deficiency they are suffering from.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Thoracic ultrasound influences physiotherapist's clinical decision-making in respiratory management of critical care patients: a multicentre cohort study.
   Le Neindre A, Hansell L, Wormser J, Gomes Lopes A, et al · · 2023 · cited 8× · PMID 35321941 · DOI 10.1136/thoraxjnl-2021-218217