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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT02881814
Ethics application status
Date submitted
24/08/2016
Date registered
29/08/2016
Date last updated
1/05/2020

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

Experimental: Lung ultrasound and clinical decision -


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.

Intervention code [1] 0 0
Diagnosis / Prognosis
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Net Reclassification Index (NRI) - Agreement (yes/no) between the lung and diaphragm US diagnosis and the clinical diagnosis and modification (yes/no) of the chest physiotherapy protocol
Timepoint [1] 0 0
Hour 1
Secondary outcome [1] 0 0
Prediction of duration of mechanical ventilation - Number of days with mechanical ventialtion
Timepoint [1] 0 0
Final study visit
Secondary outcome [2] 0 0
Prediction of mortality - Vital status at the end of ICU hospitalization
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
Gender
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
N/A
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
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
Groupe Hospitalier Paris 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
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.
Trial website
https://clinicaltrials.gov/show/NCT02881814
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
Aymeric Le Neindre, PhD
Address 0 0
Country 0 0
Phone 0 0
+331 60 64 61 30
Fax 0 0
Email 0 0
aymeric.leneindre@gmail.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT02881814