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UltraSound for Accurate Decisions in Chest PhysioTherapy (US-ADEPT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02881814
Recruitment Status : Recruiting
First Posted : August 29, 2016
Last Update Posted : February 5, 2020
Sponsor:
Collaborators:
Hôpital Forcilles
Centre Hospitalier Universitaire Dijon
St Vincent's Hospital, Sydney
Information provided by (Responsible Party):
Groupe Hospitalier Paris Saint Joseph

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.


Condition or disease Intervention/treatment Phase
Critical Illness Respiratory Disease Diagnostic Test: Lung and diaphragm ultrasound Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Prediction of duration of mechanical ventilation [ Time Frame: Final study visit ]
    Number of days with mechanical ventialtion

  2. Prediction of mortality [ Time Frame: Final study visit ]
    Vital status at the end of ICU hospitalization



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Information from the National Library of Medicine

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


Contacts
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Contact: Aymeric Le Neindre, PhD +331 60 64 61 30 aymeric.leneindre@gmail.com
Contact: Hélène Beaussier, PharmD, PhD

Locations
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Australia
St Vincent's Hospital Recruiting
Sydney, Australia, NSW2010
Contact: George Ntoumenopoulos, PhD         
Sub-Investigator: Louise Hansell, PhD         
France
Groupe Hospitalier Paris Saint Joseph Recruiting
Paris, Ile-de-France, France, 75014
Contact: Hélène Beaussier, PharmD, PhD    +33 1 44 12 70 38    hbeaussier@hpsj.fr   
Sub-Investigator: François Philippart, MD, PhD         
CHU de Dijon Recruiting
Dijon, France, 21000
Contact: Belaid Bouhemad, MD, PhD         
Hôpital Forcilles Recruiting
Férolles-Attilly, France, 77150
Contact: Aymeric Le Neindre, PhD    +336 60 64 61 30    aymeric.leneindre@gmail.com   
Sponsors and Collaborators
Groupe Hospitalier Paris Saint Joseph
Hôpital Forcilles
Centre Hospitalier Universitaire Dijon
St Vincent's Hospital, Sydney
Investigators
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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

Publications of Results:
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Responsible Party: Groupe Hospitalier Paris Saint Joseph
ClinicalTrials.gov Identifier: NCT02881814    
Other Study ID Numbers: US-ADEPT
First Posted: August 29, 2016    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Groupe Hospitalier Paris Saint Joseph:
Lung ultrasound
Chest physiotherapy
Decision-making process
Diagnostic
Additional relevant MeSH terms:
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Respiration Disorders
Critical Illness
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes