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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02881814




Registration number
NCT02881814
Ethics application status
Date submitted
24/08/2016
Date registered
29/08/2016

Titles & IDs
Public title
UltraSound for Accurate Decisions in Chest PhysioTherapy
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
Secondary ID [1] 0 0
US-ADEPT
Universal Trial Number (UTN)
Trial acronym
US-ADEPT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Critical Illness 0 0
Respiratory Disease 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Diagnosis / Prognosis
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Net Reclassification Index (NRI)
Timepoint [1] 0 0
Hour 1
Secondary outcome [1] 0 0
Prediction of duration of mechanical ventilation
Timepoint [1] 0 0
Final study visit
Secondary outcome [2] 0 0
Prediction of mortality
Timepoint [2] 0 0
Final study visit

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
2/05/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
14/04/2024
Actual
Sample size
Target
Accrual to date
Final
153
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
St Vincent's Hospital - Sydney
Recruitment postcode(s) [1] 0 0
NSW2010 - Sydney
Recruitment outside Australia
Country [1] 0 0
France
State/province [1] 0 0
Ile-de-France
Country [2] 0 0
France
State/province [2] 0 0
Dijon
Country [3] 0 0
France
State/province [3] 0 0
Férolles-Attilly

Funding & Sponsors
Primary sponsor type
Other
Name
Fondation Hôpital Saint-Joseph
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Hopital Forcilles
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Centre Hospitalier Universitaire Dijon
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
St Vincent's Hospital, Sydney
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Belaid Bouhemad, MD, PhD
Address 0 0
Centre Hospitalier Universitaire Dijon
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
The data that support the findings of this study will be openly available in "figshare".

Supporting document/s available: Statistical analysis plan (SAP), Analytic code
When will data be available (start and end dates)?
At publication.
Available to whom?
The data that support the findings of this study will be openly available
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?




Results publications and other study-related documents



Results not provided in https://clinicaltrials.gov/study/NCT02881814