UltraSound for Accurate Decisions in Chest PhysioTherapy (US-ADEPT)
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ClinicalTrials.gov Identifier: NCT02881814 |
Recruitment Status :
Active, not recruiting
First Posted : August 29, 2016
Last Update Posted : March 31, 2022
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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 |
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Critical Illness Respiratory Disease | Diagnostic Test: Lung and diaphragm ultrasound Diagnostic Test: Lung and diaphragm ultrasound in MV patients | Not Applicable |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 153 participants |
Allocation: | Non-Randomized |
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 : | May 2, 2017 |
Actual Primary Completion Date : | November 18, 2020 |
Estimated Study Completion Date : | December 14, 2022 |
Arm | Intervention/treatment |
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Experimental: Lung ultrasound and clinical decision
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.
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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. |
Experimental: Mechanically ventilated patients
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.
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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. Diagnostic Test: Lung and diaphragm ultrasound in MV patients 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. |
- 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

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

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
Australia | |
St Vincent's Hospital | |
Sydney, Australia, NSW2010 | |
France | |
Groupe Hospitalier Paris Saint Joseph | |
Paris, Ile-de-France, France, 75014 | |
CHU de Dijon | |
Dijon, France, 21000 | |
Hôpital Forcilles | |
Férolles-Attilly, France, 77150 |
Study Director: | Belaid Bouhemad, MD, PhD | Centre Hospitalier Universitaire Dijon | |
Principal Investigator: | Aymeric Le Neindre, PhD | Hopital Forcilles | |
Principal Investigator: | George Ntoumenopoulos, PhD | St. Vincent's Hospital-Manhattan |
Documents provided by Groupe Hospitalier Paris Saint Joseph:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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: | March 31, 2022 |
Last Verified: | March 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | The data that support the findings of this study will be openly available in "figshare". |
Supporting Materials: |
Statistical Analysis Plan (SAP) Analytic Code |
Time Frame: | At publication. |
Access Criteria: | The data that support the findings of this study will be openly available |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Lung ultrasound Chest physiotherapy Decision-making process Diagnostic |
Respiration Disorders Respiratory Tract Diseases Critical Illness Disease Attributes Pathologic Processes |