UltraSound for Accurate Decisions in Chest PhysioTherapy

NCT02881814 | Unknown DMC

• 1 other identifier: US-ADEPT
• Study Type: interventional
• Target: 153
• Locations: 2 countries
• Sites: 4

Brief Summary

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.

Conditions

Critical Illness; Respiratory Disease

Keywords

Lung ultrasound; Chest physiotherapy; Decision-making process; Diagnostic

Outcome Measures

Primary Outcomes (1)

• Net Reclassification Index (NRI)

  Agreement (yes/no) between the lung and diaphragm US diagnosis and the clinical diagnosis and modification (yes/no) of the chest physiotherapy protocol

  Hour 1

Secondary Outcomes (2)

• Prediction of duration of mechanical ventilation

  Final study visit

• Prediction of mortality

  Final study visit

Study Arms (2)

Lung ultrasound and clinical decision

EXPERIMENTAL

Clinical assessment and choice of chest physiotherapy treatmetn performed by the clinical physiotherapist, followed by a comprehensive lung and diaphragm ultrasonography. After ultrasonography, the clinical physiotherapist is asked what CPT treatment he was going finally to implement, and explain the reasons for change, if any.

Diagnostic Test: Lung and diaphragm ultrasound

Mechanically ventilated patients

EXPERIMENTAL

In case of mechanically ventilated patient at St. Vincent Hospital (Sydney, Australia), LUS scan will be performed immediately following intubation. Additionnal LUS scans will be performed 72h after intubation and Immediately prior to or following extubation.

Diagnostic Test: Lung and diaphragm ultrasound; Diagnostic Test: Lung and diaphragm ultrasound in MV patients

Interventions

Lung and diaphragm ultrasound DIAGNOSTIC_TEST

The ultrasound physiotherapist/operator performs a lung and diaphragm ultrasound. He is blinded to the patient's status and clinical physiotherapist examination. He/she is not involved in patient management or patient clinical decision-making. The ultrasound findings are recorded in the LUS report. The LUS report is reported to the clinical physiotherapist and to the intensivist. The ultrasound diagnosis(es) is recorded.

Lung ultrasound and clinical decision; Mechanically ventilated patients

Lung and diaphragm ultrasound in MV patients DIAGNOSTIC_TEST

In case of mechanically ventilated patient at St. Vincent Hospital (Sydney, Australia), LUS scan will be performed immediately following intubation. Additionnal LUS scans will be performed 72h after intubation and Immediately prior to or following extubation.

Mechanically ventilated patients

Eligibility Criteria

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

You may qualify if:

• Hypoxemia(SpO2/FiO2\< 315 (15))(indication for chest physiotherapy)(cf. annexe 1);
• Medical prescription for chest physiotherapy;
• First session of chest physiotherapy;
• Chest X-ray\<12h available;
• Physiotherapist/operator qualified in LUS available;
• Patient's consent.

You may not qualify if:

• Presence of a contra-indication for chest physiotherapy;
• Absence of hypoxemia;
• Absence of a prescription for chest physiotherapy;
• Absence of a chest X-ray \< 12h from the time of physiotherapy assessment;
• Physiotherapist/operator qualified in LUS not available;
• Lung and diaphragm US not possible (surgical emphysema, dressing, scarring, drains etc.);
• Refusal of the patient or a relative to participate in the study;
• Patients to be discharged on the day of the study;
• Patients in palliative care;
• Withdrawal/limitations of medical care with impending death.

Sponsors & Collaborators

• Fondation Hôpital Saint-Joseph: lead
• Hopital Forcilles: collaborator
• Centre Hospitalier Universitaire Dijon: collaborator
• St Vincent's Hospital, Sydney: collaborator

Study Sites (4)

St Vincent's Hospital

Sydney, NSW2010, Australia

Location

CHU de Dijon

Dijon, 21000, France

Location

Hôpital Forcilles

Férolles-Attilly, 77150, France

Location

Groupe Hospitalier Paris Saint Joseph

Paris, Île-de-France Region, 75014, France

Location

Related Publications (4)

• Xirouchaki N, Georgopoulos D. Impact of lung ultrasound on clinical decision making in critically ill patients: response to O'Connor et al. Intensive Care Med. 2014 Jul;40(7):1063. doi: 10.1007/s00134-014-3316-6. Epub 2014 May 6. No abstract available.

  PMID: 24797688 RESULT

• Le Neindre A, Mongodi S, Philippart F, Bouhemad B. Thoracic ultrasound: Potential new tool for physiotherapists in respiratory management. A narrative review. J Crit Care. 2016 Feb;31(1):101-9. doi: 10.1016/j.jcrc.2015.10.014. Epub 2015 Oct 26.

  PMID: 26613650 RESULT

• Leech M, Bissett B, Kot M, Ntoumenopoulos G. Lung ultrasound for critical care physiotherapists: a narrative review. Physiother Res Int. 2015 Jun;20(2):69-76. doi: 10.1002/pri.1607. Epub 2014 Dec 29.

  PMID: 25545613 RESULT

• Le Neindre A, Hansell L, Wormser J, Gomes Lopes A, Diaz Lopez C, Romanet C, Choukroun G, Nguyen M, Philippart F, Guinot PG, Buscher H, Bouhemad B, Ntoumenopoulos G. Thoracic ultrasound influences physiotherapist's clinical decision-making in respiratory management of critical care patients: a multicentre cohort study. Thorax. 2023 Feb;78(2):169-175. doi: 10.1136/thoraxjnl-2021-218217. Epub 2022 Mar 23.

  PMID: 35321941 DERIVED

MeSH Terms

Conditions

Critical Illness; Respiration Disorders; Disease

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiratory Tract Diseases

Study Officials

• Belaid Bouhemad, MD, PhD

  Centre Hospitalier Universitaire Dijon

  STUDY DIRECTOR

• Aymeric Le Neindre, PhD

  Hopital Forcilles

  PRINCIPAL INVESTIGATOR

• George Ntoumenopoulos, PhD

  St Vincent's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2016
• First Posted: August 29, 2016
• Study Start: May 2, 2017
• Primary Completion: November 18, 2020
• Study Completion: April 14, 2024
• Last Updated: September 13, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ANALYTIC CODE
• Time Frame: At publication.
• Access Criteria: The data that support the findings of this study will be openly available

Locations

AU (1); FR (3)