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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02881814
Registration number
NCT02881814
Ethics application status
Date submitted
24/08/2016
Date registered
29/08/2016
Date last updated
13/09/2023
Titles & IDs
Public title
UltraSound for Accurate Decisions in Chest PhysioTherapy
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Scientific title
Evaluation of the Impact of Lung and Diaphragm Ultrasound Findings on Clinical Decisions for Chest Physiotherapy in Patients Hospitalized in Intensive Care Units
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Secondary ID [1]
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US-ADEPT
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Universal Trial Number (UTN)
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Trial acronym
US-ADEPT
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Critical Illness
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Respiratory Disease
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Condition category
Condition code
Respiratory
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Other respiratory disorders / diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Diagnosis / Prognosis - Lung and diaphragm ultrasound
Diagnosis / Prognosis - Lung and diaphragm ultrasound in MV patients
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.
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.
Diagnosis / Prognosis: 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.
Diagnosis / Prognosis: 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.
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Intervention code [1]
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Diagnosis / Prognosis
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Net Reclassification Index (NRI)
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Assessment method [1]
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Agreement (yes/no) between the lung and diaphragm US diagnosis and the clinical diagnosis and modification (yes/no) of the chest physiotherapy protocol
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Timepoint [1]
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Hour 1
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Secondary outcome [1]
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Prediction of duration of mechanical ventilation
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Assessment method [1]
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Number of days with mechanical ventialtion
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Timepoint [1]
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Final study visit
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Secondary outcome [2]
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Prediction of mortality
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Assessment method [2]
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Vital status at the end of ICU hospitalization
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Timepoint [2]
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Final study visit
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Eligibility
Key inclusion 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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
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.
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Study design
Purpose of the study
Diagnosis
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
2/05/2017
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
14/04/2024
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Actual
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Sample size
Target
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Accrual to date
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Final
153
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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St Vincent's Hospital - Sydney
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Recruitment postcode(s) [1]
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NSW2010 - Sydney
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Recruitment outside Australia
Country [1]
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France
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State/province [1]
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Ile-de-France
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Country [2]
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France
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State/province [2]
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Dijon
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Country [3]
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France
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State/province [3]
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Férolles-Attilly
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Funding & Sponsors
Primary sponsor type
Other
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Name
Fondation Hôpital Saint-Joseph
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Address
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Other collaborator category [1]
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Other
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Name [1]
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Hopital Forcilles
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Address [1]
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Country [1]
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Other collaborator category [2]
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Other
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Name [2]
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Centre Hospitalier Universitaire Dijon
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Address [2]
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Other collaborator category [3]
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Other
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Name [3]
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St Vincent's Hospital, Sydney
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Address [3]
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02881814
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Belaid Bouhemad, MD, PhD
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Address
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Centre Hospitalier Universitaire Dijon
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Country
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Phone
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Fax
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Email
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Contact person for public queries
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Address
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Fax
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02881814
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