Lung Recruitment Device for COVID-19

NCT04361435 | Unknown DMC

• 1 other identifier: MP-21-2020-2871
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

COVID-19; Physiotherapy

Outcome Measures

Primary Outcomes (1)

• SpO2/FIO2 Ratio

  Difference before the procedure and 10 minutes from the end of the procedure

  10 minutes and 30 minutes from the end of the procedure

Secondary Outcomes (8)

• Blood pressures

  10 minutes and 30 minutes from the end of the procedure

• Heart rates

  10 minutes and 30 minutes from the end of the procedure

• Respiratory rate

  10 minutes and 30 minutes from the end of the procedure

• Body temperature

  10 minutes and 30 minutes from the end of the procedure

• Modified Wood Clinical Asthma Score (m-WCAS)

  10 minutes and 30 minutes from the end of the procedure

Study Arms (2)

NIOD first

OTHER

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

CPT first

OTHER

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

Interventions

Chest physiotherapy using a non-invasive oscillating device PROCEDURE

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; NIOD first

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• St. Justine's Hospital: lead
• Dymedso Inc.: collaborator
• Réseau de Recherche en Santé Respiratoire du Québec: collaborator
• Fonds de la Recherche en Santé du Québec: collaborator

Related Publications (22)

• Grasselli G, Zangrillo A, Zanella A, Antonelli M, Cabrini L, Castelli A, Cereda D, Coluccello A, Foti G, Fumagalli R, Iotti G, Latronico N, Lorini L, Merler S, Natalini G, Piatti A, Ranieri MV, Scandroglio AM, Storti E, Cecconi M, Pesenti A; COVID-19 Lombardy ICU Network. Baseline Characteristics and Outcomes of 1591 Patients Infected With SARS-CoV-2 Admitted to ICUs of the Lombardy Region, Italy. JAMA. 2020 Apr 28;323(16):1574-1581. doi: 10.1001/jama.2020.5394.

  PMID: 32250385 RESULT

• Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, Zhang L, Fan G, Xu J, Gu X, Cheng Z, Yu T, Xia J, Wei Y, Wu W, Xie X, Yin W, Li H, Liu M, Xiao Y, Gao H, Guo L, Xie J, Wang G, Jiang R, Gao Z, Jin Q, Wang J, Cao B. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020 Feb 15;395(10223):497-506. doi: 10.1016/S0140-6736(20)30183-5. Epub 2020 Jan 24.

  PMID: 31986264 RESULT

• Wang D, Hu B, Hu C, Zhu F, Liu X, Zhang J, Wang B, Xiang H, Cheng Z, Xiong Y, Zhao Y, Li Y, Wang X, Peng Z. Clinical Characteristics of 138 Hospitalized Patients With 2019 Novel Coronavirus-Infected Pneumonia in Wuhan, China. JAMA. 2020 Mar 17;323(11):1061-1069. doi: 10.1001/jama.2020.1585.

  PMID: 32031570 RESULT

• Wu Z, McGoogan JM. Characteristics of and Important Lessons From the Coronavirus Disease 2019 (COVID-19) Outbreak in China: Summary of a Report of 72 314 Cases From the Chinese Center for Disease Control and Prevention. JAMA. 2020 Apr 7;323(13):1239-1242. doi: 10.1001/jama.2020.2648. No abstract available.

  PMID: 32091533 RESULT

• Yang X, Yu Y, Xu J, Shu H, Xia J, Liu H, Wu Y, Zhang L, Yu Z, Fang M, Yu T, Wang Y, Pan S, Zou X, Yuan S, Shang Y. Clinical course and outcomes of critically ill patients with SARS-CoV-2 pneumonia in Wuhan, China: a single-centered, retrospective, observational study. Lancet Respir Med. 2020 May;8(5):475-481. doi: 10.1016/S2213-2600(20)30079-5. Epub 2020 Feb 24.

  PMID: 32105632 RESULT

• Kanne JP, Little BP, Chung JH, Elicker BM, Ketai LH. Essentials for Radiologists on COVID-19: An Update-Radiology Scientific Expert Panel. Radiology. 2020 Aug;296(2):E113-E114. doi: 10.1148/radiol.2020200527. Epub 2020 Feb 27. No abstract available.

  PMID: 32105562 RESULT

• Pan F, Ye T, Sun P, Gui S, Liang B, Li L, Zheng D, Wang J, Hesketh RL, Yang L, Zheng C. Time Course of Lung Changes at Chest CT during Recovery from Coronavirus Disease 2019 (COVID-19). Radiology. 2020 Jun;295(3):715-721. doi: 10.1148/radiol.2020200370. Epub 2020 Feb 13.

  PMID: 32053470 RESULT

• Shi H, Han X, Jiang N, Cao Y, Alwalid O, Gu J, Fan Y, Zheng C. Radiological findings from 81 patients with COVID-19 pneumonia in Wuhan, China: a descriptive study. Lancet Infect Dis. 2020 Apr;20(4):425-434. doi: 10.1016/S1473-3099(20)30086-4. Epub 2020 Feb 24.

  PMID: 32105637 RESULT

• Roque i Figuls M, Gine-Garriga M, Granados Rugeles C, Perrotta C, Vilaro J. Chest physiotherapy for acute bronchiolitis in paediatric patients between 0 and 24 months old. Cochrane Database Syst Rev. 2016 Feb 1;2(2):CD004873. doi: 10.1002/14651858.CD004873.pub5.

  PMID: 26833493 RESULT

• Chaves GS, Freitas DA, Santino TA, Nogueira PAM, Fregonezi GA, Mendonca KM. Chest physiotherapy for pneumonia in children. Cochrane Database Syst Rev. 2019 Jan 2;1(1):CD010277. doi: 10.1002/14651858.CD010277.pub3.

  PMID: 30601584 RESULT

• Hough JL, Flenady V, Johnston L, Woodgate PG. Chest physiotherapy for reducing respiratory morbidity in infants requiring ventilatory support. Cochrane Database Syst Rev. 2008 Jul 16;2008(3):CD006445. doi: 10.1002/14651858.CD006445.pub2.

  PMID: 18646156 RESULT

• Lauwers E, Ides K, Van Hoorenbeeck K, Verhulst S. The effect of intrapulmonary percussive ventilation in pediatric patients: A systematic review. Pediatr Pulmonol. 2018 Nov;53(11):1463-1474. doi: 10.1002/ppul.24135. Epub 2018 Jul 18.

  PMID: 30019451 RESULT

• Ferreira LL, Valenti VE, Vanderlei LC. Chest physiotherapy on intracranial pressure of critically ill patients admitted to the intensive care unit: a systematic review. Rev Bras Ter Intensiva. 2013 Oct-Dec;25(4):327-33. doi: 10.5935/0103-507X.20130055.

  PMID: 24553515 RESULT

• Schieppati D, Germon R, Galli F, Rigamonti MG, Stucchi M, Boffito DC. Influence of frequency and amplitude on the mucus viscoelasticity of the novel mechano-acoustic Frequencer. Respir Med. 2019 Jul;153:52-59. doi: 10.1016/j.rmed.2019.04.011. Epub 2019 May 27.

  PMID: 31163350 RESULT

• Cantin AM, Bacon M, Berthiaume Y. Mechanical airway clearance using the frequencer electro-acoustical transducer in cystic fibrosis. Clin Invest Med. 2006 Jun;29(3):159-65.

  PMID: 17058435 RESULT

• Adams JY, Rogers AJ, Schuler A, Marelich GP, Fresco JM, Taylor SL, Riedl AW, Baker JM, Escobar GJ, Liu VX. Association Between Peripheral Blood Oxygen Saturation (SpO2)/Fraction of Inspired Oxygen (FiO2) Ratio Time at Risk and Hospital Mortality in Mechanically Ventilated Patients. Perm J. 2020;24:19.113. doi: 10.7812/TPP/19.113. Epub 2020 Jan 31.

  PMID: 32069205 RESULT

• Bilan N, Dastranji A, Ghalehgolab Behbahani A. Comparison of the spo2/fio2 ratio and the pao2/fio2 ratio in patients with acute lung injury or acute respiratory distress syndrome. J Cardiovasc Thorac Res. 2015;7(1):28-31. doi: 10.15171/jcvtr.2014.06. Epub 2015 Mar 29.

  PMID: 25859313 RESULT

• Ghazal S, Sauthier M, Brossier D, Bouachir W, Jouvet PA, Noumeir R. Using machine learning models to predict oxygen saturation following ventilator support adjustment in critically ill children: A single center pilot study. PLoS One. 2019 Feb 20;14(2):e0198921. doi: 10.1371/journal.pone.0198921. eCollection 2019.

  PMID: 30785881 RESULT

• Koyauchi T, Yasui H, Enomoto N, Hasegawa H, Hozumi H, Suzuki Y, Karayama M, Furuhashi K, Fujisawa T, Nakamura Y, Inui N, Yokomura K, Suda T. Pulse oximetric saturation to fraction of inspired oxygen (SpO2/FIO2) ratio 24 hours after high-flow nasal cannula (HFNC) initiation is a good predictor of HFNC therapy in patients with acute exacerbation of interstitial lung disease. Ther Adv Respir Dis. 2020 Jan-Dec;14:1753466620906327. doi: 10.1177/1753466620906327.

  PMID: 32046604 RESULT

• Kwack WG, Lee DS, Min H, Choi YY, Yun M, Kim Y, Lee SH, Song I, Park JS, Cho YJ, Jo YH, Yoon HI, Lee JH, Lee CT, Lee YJ. Evaluation of the SpO2/FiO2 ratio as a predictor of intensive care unit transfers in respiratory ward patients for whom the rapid response system has been activated. PLoS One. 2018 Jul 31;13(7):e0201632. doi: 10.1371/journal.pone.0201632. eCollection 2018.

  PMID: 30063769 RESULT

• Wiedermann FJ, Stichlberger M, Glodny B. ARDS diagnosed by SpO2/FiO2 ratio compared with PaO2/FiO2 ratio: the role as a diagnostic tool for early enrolment into clinical trials. Open Med (Wars). 2016 Aug 2;11(1):297. doi: 10.1515/med-2016-0056. eCollection 2016. No abstract available.

  PMID: 28352811 RESULT

• Kawaguchi A, Bernier G, Lacroix J, El Salti S, Cheng MP, Lee TC, Khwaja K, Jouvet P. Comparison of two methods to clear the airways of critically ill children and adults with COVID-19 infection: a structured summary of a study protocol for a pilot randomized controlled trial. Trials. 2020 Jul 3;21(1):610. doi: 10.1186/s13063-020-04533-6.

  PMID: 32620174 DERIVED

Related Links

• Dymedso Inc.

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Philippe Jouvet, MD PhD MBA

  St. Justine's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Saly Salti, MSc

CONTACT

+1-514-345-4927; salysalti@hotmail.com

Atsushi Kawaguchi, MD PhD

CONTACT

514-912-4247; atsushi@ualberta.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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).

Study Record Dates

• First Submitted: April 12, 2020
• First Posted: April 24, 2020
• Study Start: May 1, 2020
• Primary Completion: July 31, 2020
• Study Completion: December 31, 2020
• Last Updated: April 28, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share