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UltraSound for Accurate Decisions in Chest PhysioTherapy (US-ADEPT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02881814
Recruitment Status : Recruiting
First Posted : August 29, 2016
Last Update Posted : February 5, 2020
Sponsor:
Collaborators:
Hôpital Forcilles
Centre Hospitalier Universitaire Dijon
St Vincent's Hospital, Sydney
Information provided by (Responsible Party):
Groupe Hospitalier Paris Saint Joseph

Tracking Information
First Submitted Date  ICMJE August 24, 2016
First Posted Date  ICMJE August 29, 2016
Last Update Posted Date February 5, 2020
Actual Study Start Date  ICMJE November 14, 2017
Estimated Primary Completion Date March 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 30, 2017)
Net Reclassification Index (NRI) [ Time Frame: Hour 1 ]
Agreement (yes/no) between the lung and diaphragm US diagnosis and the clinical diagnosis and modification (yes/no) of the chest physiotherapy protocol
Original Primary Outcome Measures  ICMJE
 (submitted: August 24, 2016)
Net Reclassification Index (NRI) assessment [ Time Frame: Hour 12 ]
Changing the clinical decision process: Concordance (yes / no) between the results of pulmonary and diaphragmatic ultrasound and clinical diagnosis and modification (yes / no) treatment in respiratory physiotherapy. It is expressed by calculating the Net Reclassification Index (NRI).
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 26, 2018)
  • Prediction of duration of mechanical ventilation [ Time Frame: Final study visit ]
    Number of days with mechanical ventialtion
  • Prediction of mortality [ Time Frame: Final study visit ]
    Vital status at the end of ICU hospitalization
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE UltraSound for Accurate Decisions in Chest PhysioTherapy
Official Title  ICMJE Evaluation of the Impact of Lung and Diaphragm Ultrasound Findings on Clinical Decisions for Chest Physiotherapy in Patients Hospitalized in Intensive Care Units
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.

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, 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Critical Illness
  • Respiratory Disease
Intervention  ICMJE Diagnostic Test: 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.
Study Arms  ICMJE Experimental: Lung ultrasound and clinical decision
Intervention: Diagnostic Test: Lung and diaphragm ultrasound
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 24, 2016)
150
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 14, 2020
Estimated Primary Completion Date March 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Aymeric Le Neindre, PhD +331 60 64 61 30 aymeric.leneindre@gmail.com
Contact: Hélène Beaussier, PharmD, PhD
Listed Location Countries  ICMJE Australia,   France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02881814
Other Study ID Numbers  ICMJE US-ADEPT
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Groupe Hospitalier Paris Saint Joseph
Study Sponsor  ICMJE Groupe Hospitalier Paris Saint Joseph
Collaborators  ICMJE
  • Hôpital Forcilles
  • Centre Hospitalier Universitaire Dijon
  • St Vincent's Hospital, Sydney
Investigators  ICMJE
Study Director: Belaid Bouhemad, MD, PhD Centre Hospitalier Universitaire Dijon
Principal Investigator: Aymeric Le Neindre, PhD Hôpital Forcilles
Principal Investigator: George Ntoumenopoulos, PhD St. Vincent's Hospital-Manhattan
PRS Account Groupe Hospitalier Paris Saint Joseph
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP