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Trial details imported from

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Registration number
Ethics application status
Date submitted
Date registered
Date last updated

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
Universal Trial Number (UTN)
Trial acronym
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

Study type
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

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

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
Both males and females
Can healthy volunteers participate?
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

- 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
Allocation to intervention
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
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
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
State/province [1] 0 0
Country [2] 0 0
State/province [2] 0 0
Country [3] 0 0
State/province [3] 0 0

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

Ethics approval
Ethics application status

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
Trial related presentations / publications
Public notes

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
Contact person for scientific queries

Summary results
For IPD and results data, please see