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Critical IllnessUS-ADEPTNCT02881814

UltraSound for Accurate Decisions in Chest PhysioTherapy

A study testing Lung and diaphragm ultrasound and Lung and diaphragm ultrasound in MV patients in people with Critical Illness and Respiratory Disease, run by Fondation Hôpital Saint-Joseph at 4 sites in 2 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Critical Illness, Respiratory Disease
What is being tested?
Lung and diaphragm ultrasound and Lung and diaphragm ultrasound in MV patients
Could I receive a placebo?
No, everyone receives an active treatment
How many people
153 participants
Where
4 sitesin 2 countries
Study dates
2 May 2017to 14 Apr 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.);
Show all 10Show fewer
  • 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.

Trial locations and contacts

4 sites in 2 countries.

4 sites in 2 countries

France3 sites
  • CHU de Dijon

    Dijon, 21000

  • Hôpital Forcilles

    Férolles-Attilly, 77150

  • Groupe Hospitalier Paris Saint Joseph

    Paris, Île-de-France Region, 75014

Other trials in France

Australia1 site
  • St Vincent's Hospital

    Sydney, NSW2010

Other trials in Australia

About this study

Official title: Evaluation of the Impact of Lung and Diaphragm Ultrasound Findings on Clinical Decisions for Chest Physiotherapy in Patients Hospitalized in Intensive Care Units

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.

Read more

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.

Read the detailed description

Research hypothesis The lung and diaphragm ultrasound findings provided to the physiotherapist will modify his/her clinical decision-making in regards to chest physiotherapy treatment in the critical care patient.

Objectives Principal objective The principal objective of this study is to evaluate the impact of using the results of lung and diaphragm US on clinical decisions by physiotherapists regarding chest physiotherapy in patients hospitalized in an ICU.

Secondary objectives

  1. Determine the accuracy of physiotherapist diagnosis of lung pathology using routine clinical assessment versus LUS findings;
  2. Determine the frequency of change in chest physiotherapy treatment with the addition of LUS results to clinical assessment;
  3. Determine the frequency of change in medical treatment (determined by intensivist) following the addition of LUS results to clinical assessment findings.
  4. Evaluate the diagnostic accuracy of LUS in predicting duration of mechanical ventilation and mortality.

Methodology:

Type of study This is a multi-centre prospective (patients enrolled on admission) interventional study evaluating a routine assessment/treatment. The study intends to assess the impact of lung and diaphragm ultrasound on the usual physiotherapist's clinical decision-making process. Each included patient will be clinically assessed by a clinical physiotherapist, and then will have a lung and diaphragm ultrasound by another physiotherapist/operator blinded to the clinical assessment findings. The lung and diaphragm ultrasound findings will then be presented to both the intensivist and clinical physiotherapist to evaluate the impact on the independent clinical decision-making by both the intensivist and physiotherapist.

Data collections

The following data will be collected:

  • Demographic: age, sex, BMI, smoking, alcohol consumption, history of cirrhosis, diabetes or a chronic respiratory disease, heart failure;
  • Reason for hospitalization, medical diagnosis if different;
  • Treatments: hypnotics, opiates, steroids and anti-hypertensives, oxygen therapy, mechanical ventilation, NIV, tracheotomy;
  • Duration of mechanical ventilation
  • Duration of ICU stay
  • Vital signs: RR, HR, PA, SpO2, RASS, Glasgow;
  • Clinical hypotheses of the clinical physiotherapist;
  • LUS findings;
  • Choice of chest physiotherapy protocol (before and after ultrasonography).

Nature of the routine care to be evaluated Procedure 1: Decision-making process in chest physiotherapy The clinical physiotherapist is the physiotherapist who manages patients in the CCU.

As soon as chest physiotherapy is prescribed, the physiotherapist carries out a clinical examination and analyses the complementary tests (chest X-ray, chest CT-scan and blood gasses if available). He/she also consults the patient's medical record to find out the reason for admission to the CCU and the medical diagnosis if the critical care physician has made one. Following the examination, he/she will put forward one or several hypotheses concerning the respiratory deficiency (and not the disease - medical diagnosis) 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 (see below) 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. It will specify the respiratory physiotherapy protocol according to the results of the US-scan.

Procedure 2: lung and diaphragm US The LUS will be performed by the physiotherapist/operator, who will be blinded to the clinical evaluation of the clinical physiotherapist and the patient's status. The operator will not take part in the management of the patients concerned. The semiology of lung and diaphragm US is described. The following syndromes will be searched for: normal profile, alveolar-interstitial syndrome, pulmonary consolidation, pleural effusion, pneumothorax and diaphragm dysfunction. The physiotherapist/operator will write a detailed LUS-scan report, which will be given to the clinical physiotherapist. It will include the LUS diagnosis and describe the signs observed in the different regions of the chest. The clinical physiotherapist is trained to interpret LUS reports.

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.

Number of patients to recruit and duration of participation for each patient Given the high prevalence of hypoxemia in ICUs, the systematic respiratory assessment in these patients by the physiotherapist and our relatively non-restrictive inclusion criteria, we believe we can recruit more than 300 patients per year.

Being tested
Lung and diaphragm ultrasound, Lung and diaphragm ultrasound in MV patients
Keywords
Lung ultrasound, Chest physiotherapy, Decision-making process, Diagnostic
Medical subject headings
Critical Illness, Respiration Disorders, Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lung and diaphragm ultrasoundDiagnostic test

    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.

  • Lung and diaphragm ultrasound in MV patientsDiagnostic test

    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.

Study groups in NCT02881814
Study groupRoleWhat they receive
Lung ultrasound and clinical decisionExperimentalClinical 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.
Receives: Diagnostic Test: Lung and diaphragm ultrasound
Mechanically ventilated patientsExperimentalIn 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.
Receives: Diagnostic Test: Lung and diaphragm ultrasound; Diagnostic Test: Lung and diaphragm ultrasound in MV patients

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Hour 1

Secondary outcomes (2)
  1. Prediction of duration of mechanical ventilation

    Number of days with mechanical ventialtion

    Measured: Final study visit

  2. Prediction of mortality

    Vital status at the end of ICU hospitalization

    Measured: Final study visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Aug 2016 (estimated)
  2. Study start2 May 2017
  3. Primary completion18 Nov 2020
  4. Study completion14 Apr 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
153 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02881814
Sponsor's protocol ID
US-ADEPT
Acronym
US-ADEPT
Status last verified
Sep 2023
First submitted
24 Aug 2016
Last updated
13 Sep 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The data that support the findings of this study will be openly available in "figshare".

Publications

  • Xirouchaki N, Georgopoulos D. Impact of lung ultrasound on clinical decision making in critically ill patients: response to O'Connor et al. Intensive Care Med. 2014 Jul;40(7):1063. doi: 10.1007/s00134-014-3316-6. Epub 2014 May 6. No abstract available.

    PubMed 24797688
  • Le Neindre A, Mongodi S, Philippart F, Bouhemad B. Thoracic ultrasound: Potential new tool for physiotherapists in respiratory management. A narrative review. J Crit Care. 2016 Feb;31(1):101-9. doi: 10.1016/j.jcrc.2015.10.014. Epub 2015 Oct 26.

    PubMed 26613650
  • Leech M, Bissett B, Kot M, Ntoumenopoulos G. Lung ultrasound for critical care physiotherapists: a narrative review. Physiother Res Int. 2015 Jun;20(2):69-76. doi: 10.1002/pri.1607. Epub 2014 Dec 29.

    PubMed 25545613
  • Le Neindre A, Hansell L, Wormser J, Gomes Lopes A, Diaz Lopez C, Romanet C, Choukroun G, Nguyen M, Philippart F, Guinot PG, Buscher H, Bouhemad B, Ntoumenopoulos G. Thoracic ultrasound influences physiotherapist's clinical decision-making in respiratory management of critical care patients: a multicentre cohort study. Thorax. 2023 Feb;78(2):169-175. doi: 10.1136/thoraxjnl-2021-218217. Epub 2022 Mar 23.

    PubMed 35321941

Questions about this trial

What is this clinical trial studying?

A study testing Lung and diaphragm ultrasound and Lung and diaphragm ultrasound in MV patients in people with Critical Illness and Respiratory Disease, run by Fondation Hôpital Saint-Joseph at 4 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 13 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in France, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Net Reclassification Index (NRI) (time frame: Hour 1). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02881814, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2023.

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