UltraSound for Accurate Decisions in Chest PhysioTherapy (US-ADEPT)
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|ClinicalTrials.gov Identifier: NCT02881814|
Recruitment Status : Recruiting
First Posted : August 29, 2016
Last Update Posted : February 5, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Critical Illness Respiratory Disease||Diagnostic Test: Lung and diaphragm ultrasound||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of the Impact of Lung and Diaphragm Ultrasound Findings on Clinical Decisions for Chest Physiotherapy in Patients Hospitalized in Intensive Care Units|
|Actual Study Start Date :||November 14, 2017|
|Estimated Primary Completion Date :||March 31, 2020|
|Estimated Study Completion Date :||September 14, 2020|
|Experimental: Lung ultrasound and clinical decision||
Diagnostic Test: Lung and diaphragm ultrasound
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.
- Net Reclassification Index (NRI) [ Time Frame: Hour 1 ]Agreement (yes/no) between the lung and diaphragm US diagnosis and the clinical diagnosis and modification (yes/no) of the chest physiotherapy protocol
- Prediction of duration of mechanical ventilation [ Time Frame: Final study visit ]Number of days with mechanical ventialtion
- Prediction of mortality [ Time Frame: Final study visit ]Vital status at the end of ICU hospitalization
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02881814
|Contact: Aymeric Le Neindre, PhD||+331 60 64 61 firstname.lastname@example.org|
|Contact: Hélène Beaussier, PharmD, PhD|
|St Vincent's Hospital||Recruiting|
|Sydney, Australia, NSW2010|
|Contact: George Ntoumenopoulos, PhD|
|Sub-Investigator: Louise Hansell, PhD|
|Groupe Hospitalier Paris Saint Joseph||Recruiting|
|Paris, Ile-de-France, France, 75014|
|Contact: Hélène Beaussier, PharmD, PhD +33 1 44 12 70 38 email@example.com|
|Sub-Investigator: François Philippart, MD, PhD|
|CHU de Dijon||Recruiting|
|Dijon, France, 21000|
|Contact: Belaid Bouhemad, MD, PhD|
|Férolles-Attilly, France, 77150|
|Contact: Aymeric Le Neindre, PhD +336 60 64 61 30 firstname.lastname@example.org|
|Study Director:||Belaid Bouhemad, MD, PhD||Centre Hospitalier Universitaire Dijon|
|Principal Investigator:||Aymeric Le Neindre, PhD||Hôpital Forcilles|
|Principal Investigator:||George Ntoumenopoulos, PhD||St. Vincent's Hospital-Manhattan|