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Lung Recruitment Device for COVID-19

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ClinicalTrials.gov Identifier: NCT04361435
Recruitment Status : Not yet recruiting
First Posted : April 24, 2020
Last Update Posted : April 28, 2020
Sponsor:
Collaborators:
Dymedso Inc.
Réseau de Recherche en Santé Respiratoire du Québec
Fonds de la Recherche en Santé du Québec
Information provided by (Responsible Party):
Philippe Jouvet, St. Justine's Hospital

Brief Summary:

INTRODUCTION As there is no specific cure in the treatment of COVID-19 at this moment of the pandemic, supportive management including mechanical ventilation is the core management in an intensive care unit (ICU). It is a challenge to provide consistent care in this situation of high demand and potential staff shortage in ICU. Also, the investigators need to reduce unnecessary exposure of the providers to the virus. This study aims to examine the impact of care using a non-invasive oscillating device (NIOD) for chest physiotherapy in the care of mechanically ventilated patients with COVID-19.

METHODS Objective: To explore if a NIOD performed by non-specialized personnel is not inferior to the standard Chest PhysioTherapy (CPT) in the care of COVID-19.

Design: A Pilot Multicenter Prospective Crossover Randomized Study. Setting: Two ICUs in Canadian Academic Hospitals (CHU Sainte Justine and Montreal General Hospital) Patients: All the mechanically ventilated patients admitted to the two ICUs, and CPT ordered by the responsible physician, with COVID-19 infection during the study period.

Procedure: The investigators will implement NIOD and CPT alternatingly for 3 hours apart over 3 hours. We will apply a pragmatic design, so that other procedures including hypertonic saline nebulization, Intermittent Positive Pressure Ventilation (IPPV), suctioning (e.g., oral or nasal), or changing the ventilator settings or modality can be provided at the direction of bedside intensivists in charge. The order of the procedures (i.e. NIOD or CPT) will be randomly allocated.

Measurements and Analyses: The primary outcome measure is the oxygenation level before and after the procedure (SpO2/FIO2 (SF) ratio). For the cases with Invasive ventilation and non-invasive ventilation, the investigators will also document expiratory tidal volume, vital signs, and any related complications such as vomiting, desaturations, or unexpected extubations. The investigators will collect the data before, 10 minutes after, and 30 minutes after the procedure.

Sample Size: The investigators estimate the necessary sample size as 25 for each arm (Total 50 cases), with a power of 0.90, alfa of 0.05, with the non-inferiority design.

FUTURE CONSIDERATIONS This randomized pilot study will be considered a running phase if the investigators can/should undertake the RCT which should follow without significant modification of the methods.


Condition or disease Intervention/treatment Phase
COVID-19 Physiotherapy Procedure: Chest physiotherapy using a non-invasive oscillating device Not Applicable

Show Show detailed description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Patients will be randomized into one of the 2 arms (None-invasive oscillating device (NIOD) first or chest physiotherapy (CPT) first). Random allocation will be generated by an independent investigator in an equal number assigned to each intervention. Stratification will be applied for age (>18 years or =<18 years of age) and sites (CHUSJ and General Hospital).
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Comparison of Two Methods to Airway Clearance in Patients Admitted to Intensive Care Unit for COVID-19: A Pilot Corssover Randomized Controlled Trial
Estimated Study Start Date : May 1, 2020
Estimated Primary Completion Date : July 31, 2020
Estimated Study Completion Date : December 31, 2020

Arm Intervention/treatment
NIOD first
In this arm, we will apply for NIOD first which will be performed by non-physiotherapists such as respiratory therapists and bedside nurses. This arm of patients will receive standard CPT at least 3 hours after the NIOD intervention.
Procedure: Chest physiotherapy using a non-invasive oscillating device
NIOD will be implemented on four different parts of the chest walls, 3 minutes for each part and 12 minutes in total per each session. Left and right front and posterior chest walls will be stimulated, particularly, on the anterior chest, intercostal spaces 1-2 above nipple line and lateral side of the mid-clavicular line 1-2 below intercostal spaces. The intensity of the NIOD can be selected between 80-100%, which is pre-specified on the machine.

CPT first
In this arm, we will apply for CPT first which will be performed by physiotherapists. This arm of patients will receive NIOD procedures which will be performed by non-physiotherapists such as respiratory therapists and bedside nurses at least 3 hours after the CPT intervention.
Procedure: Chest physiotherapy using a non-invasive oscillating device
NIOD will be implemented on four different parts of the chest walls, 3 minutes for each part and 12 minutes in total per each session. Left and right front and posterior chest walls will be stimulated, particularly, on the anterior chest, intercostal spaces 1-2 above nipple line and lateral side of the mid-clavicular line 1-2 below intercostal spaces. The intensity of the NIOD can be selected between 80-100%, which is pre-specified on the machine.




Primary Outcome Measures :
  1. SpO2/FIO2 Ratio [ Time Frame: 10 minutes and 30 minutes from the end of the procedure ]
    Difference before the procedure and 10 minutes from the end of the procedure


Secondary Outcome Measures :
  1. Blood pressures [ Time Frame: 10 minutes and 30 minutes from the end of the procedure ]
    Changes in values

  2. Heart rates [ Time Frame: 10 minutes and 30 minutes from the end of the procedure ]
    Changes in values

  3. Respiratory rate [ Time Frame: 10 minutes and 30 minutes from the end of the procedure ]
    Changes in values

  4. Body temperature [ Time Frame: 10 minutes and 30 minutes from the end of the procedure ]
    Changes in values

  5. Modified Wood Clinical Asthma Score (m-WCAS) [ Time Frame: 10 minutes and 30 minutes from the end of the procedure ]
    Changes in values (0 to 10, worse outcome is 10)

  6. Expiratory tidal lung volume. [ Time Frame: 10 minutes and 30 minutes from the end of the procedure ]
    Changes in volume.

  7. End-tidal CO2 [ Time Frame: 10 minutes and 30 minutes from the end of the procedure ]
    Changes in values and blood gas parameters.

  8. Clinical Respiratory severity scores. [ Time Frame: 10 minutes and 30 minutes from the end of the procedure ]
    Changes in scores



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

All the patients admitted to the ICUs during the study period will be screened. We will not set any restrictions regarding the timing of the prescription of CPT (i.e., length of ICU stay before screening) for the screening. We will include only if CPT is expected to be used as management at least for the next 24 hours in the ICUs from the time of inclusion. For instance, if CPT will be expected to be discontinued from the management in a day, we will exclude them from the inclusion. CPT can be prescribed for airway clearance with any etiology such as atelectasis at the directions of bedside intensivists in charge of the study date.

Specific Inclusion criteria

  • Patients diagnosed as COVID-19
  • Patents strongly suspected its infection and the result of virological testing is pending as of screening.
  • Patients with any type of mechanical ventilation (i.e., Invasive, non-invasive, high flow nasal therapy)
  • Patients are on standard oxygen by mask or nasal cannula and the FiO2 provided can be measurable.
  • Patients who are on respiratory monitoring at least SpO2 can be continuously measurable.

Exclusion Criteria:

  • CPT order will (or is expected to) be discontinued within 12 hours from the inclusion timing. This may include potential discharge from the unit.
  • CPT is not ordered for airway clearance.
  • SpO2 is not stable (SpO2=<80%) with more than 0.60 of FIO2 for ventilated patients including patients on NIV, at least for the previous 1 hour from the screening.
  • SpO2 is not stable (SpO2=<80%) with more than 0.60 of FIO2 for the patients on HFNC, at least for the previous 1 hour from the screening.
  • Bradycardia (HR<50bpm) at any intervention at least 24 hours before the screening.
  • Patients with known pneumothorax, osteomyelitis at ICU admission.
  • Thoracotomy within 1 month from the admission date.
  • Known recent/unhealed rib fractures.
  • Known skin injury of the chest wall.
  • No, obtain of IC.
  • Brain death or vegetated states.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04361435


Contacts
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Contact: Saly Salti, MSc +1-514-345-4927 salysalti@hotmail.com
Contact: Atsushi Kawaguchi, MD PhD 514-912-4247 atsushi@ualberta.ca

Sponsors and Collaborators
St. Justine's Hospital
Dymedso Inc.
Réseau de Recherche en Santé Respiratoire du Québec
Fonds de la Recherche en Santé du Québec
Investigators
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Principal Investigator: Philippe Jouvet, MD PhD MBA St. Justine's Hospital
Additional Information:
Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Philippe Jouvet, Professor, St. Justine's Hospital
ClinicalTrials.gov Identifier: NCT04361435    
Other Study ID Numbers: MP-21-2020-2871
First Posted: April 24, 2020    Key Record Dates
Last Update Posted: April 28, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: All the study documents will be shared only among the two sites. The summarized cleaned data will be shared with the co-investigators in both study sites.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No