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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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26 September 2023 |
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Main ID: |
NCT02881814 |
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Date of registration:
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24/08/2016 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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UltraSound for Accurate Decisions in Chest PhysioTherapy
US-ADEPT |
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Scientific title:
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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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Date of first enrolment:
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May 2, 2017 |
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Target sample size:
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153 |
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Recruitment status: |
Active, not recruiting |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT02881814 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized. Intervention model: Single Group Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Australia
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France
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Contacts
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Name:
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Aymeric Le Neindre, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hopital Forcilles |
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Name:
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Belaid Bouhemad, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Centre Hospitalier Universitaire Dijon |
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Name:
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George Ntoumenopoulos, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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St Vincent's Hospital |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Critical Illness
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Respiratory Disease
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Intervention(s)
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Diagnostic Test: Lung and diaphragm ultrasound
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Diagnostic Test: Lung and diaphragm ultrasound in MV patients
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Primary Outcome(s)
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Net Reclassification Index (NRI)
[Time Frame: Hour 1]
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Secondary Outcome(s)
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Prediction of mortality
[Time Frame: Final study visit]
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Prediction of duration of mechanical ventilation
[Time Frame: Final study visit]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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