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CTRI Number  CTRI/2022/12/048008 [Registered on: 12/12/2022] Trial Registered Prospectively
Last Modified On: 09/12/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Medical Device
Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Effect of airway clearance device on function and quality of life in stable ICU patients. 
Scientific Title of Study   Effect of Airphysio device on lung function, physical performance, functional capacity and Health related Quality of Life in ICU survivors: A Prospective, Double-blinded Randomized Controlled Trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Vrushali Panhale 
Designation  Professor 
Affiliation  MGM College of Physiotherapy 
Address  Department of Musculoskeletal Physiotherapy,MGM College of Physiotherapy, First floor,Plot-46, Sector 30 A, Vashi, Navi Mumbai

Thane
MAHARASHTRA
400705
India 
Phone    
Fax    
Email  vrushali.d@rediffmail.com  
 
Details of Contact Person
Scientific Query  
Name  ShrutI Nair 
Designation  Associate Professor 
Affiliation  MGM College of Physiotherapy 
Address  Department of Cardiovascular & Respiratory Physiotherapy, First floor, MGM College of Physiotherapy, Plot-46, Sector 30 A, Vashi, Navi Mumbai

Thane
MAHARASHTRA
400705
India 
Phone    
Fax    
Email  shrutinair@mgmcopnm.edu.in  
 
Details of Contact Person
Public Query  
Name  Vrushali Panhale 
Designation  Professor 
Affiliation  MGM College of Physiotherapy 
Address  Department of Musculoskeletal Physiotherapy, First Floor, MGM College of Physiotherapy,Plot-46, Sector 30 A, Vashi, Navi Mumbai

Thane
MAHARASHTRA
400705
India 
Phone    
Fax    
Email  vrushali.d@rediffmail.com  
 
Source of Monetary or Material Support  
MGM College of Physiotherapy, Plot no 46, Sector 30 A, Vashi-400705, Navi Mumbai 
 
Primary Sponsor  
Name  MGM College of Physiotherapy 
Address  Sector-30 A,Vashi, Navi Mumbai-400705, Maharashtra, India 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Shruti Nair  MGM Hospital  Plot No. 1 & 2, Sector-1, NH-4 Junction, Mumbai - Pune Hwy, Kamothe, Navi Mumbai, Maharashtra 410209
Raigarh
MAHARASHTRA 		 9769323125

shrutinair@mgmcopnm.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee MGM Dental College & Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J99||Respiratory disorders in diseasesclassified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  AirPhysio device with ball bearing size of 17 mm and Conventional therapy  Use of Airphysio: Participants would be taught the correct technique to use the Airphysio device and they would be asked to use it 10 times for three sets for 3 times a day. Adequate rest pauses would be given to prevent hyperventilation. Conventional therapy: Additionally, breathing exercises in the form of diaphragmatic breathing, segmental breathing, thoracic expansion exercises, pursed lip breathing exercise and airway clearance techniques will be taught to the patients along with individually tailored mobilization training. Criteria for Termination of intervention: 1.Hemodynamic instability such as and Blood pressure ≥ 190/100 mmHg and Heart rate 120 bpm or 60 bpm 2.Any sign of respiratory distress with oxygen saturation 90% or a drop by ≥ 3% and Respiratory rate 40 breaths/minute. Patients who get discharged before 4 weeks would be taught home exercise program and would be followed up for tele-rehabilitation once a day for the remaining days of intervention. 6.Post 4 weeks of intervention, all the participants would be re-assessed to document changes in lung function, physical performance, functional capacity and QOL.  
Comparator Agent  Sham device and Conventional therapy  Use of Sham device: Participants would be taught the correct technique to use the Sham device and they would be asked to use it 10 times for three sets for 3 times a day. Adequate rest pauses would be given to prevent hyperventilation. Conventional therapy: Additionally, breathing exercises in the form of diaphragmatic breathing, segmental breathing, thoracic expansion exercises, pursed lip breathing exercise and airway clearance techniques will be taught to the patients along with individually tailored mobilization training.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  (1)Patients who are spontaneously breathing or on non-invasive ventilatory support in intensive care unit
(2) Patients extubated for more than 8 hours who were previously intubated
(3) Patients showing radiographic changes of sputum retention, consolidation and pulmonary infiltrates
(4) Patients who are above 18 years
(5) Patient who consent to participate 
 
ExclusionCriteria 
Details  (1) Patients who are hemodynamically unstable
(2) Patients with untreated pneumothorax, emphysematous bullae, rib fractures etc
(3) History of any recent major cardiac and neurosurgery
(4) Patients who are tracheostomized during the ICU stay
(5) Any neuro-musculoskeletal disorder that prevents them from performing the tests
(6) Patients with cognitive impairment that prevents them from understanding the instructions
(7) Patients who are agitated or sedated as assessed using Richmond Agitation Sedation Scale (RASS more than -1 or +1)
(8) Participant who are not willing to participate 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Primary outcome/s (1)Lung function : Pulmonary function (FEV1, FVC) , Respiratory muscle strength (Maximal Inspiratory Pressure, Maximal Expiratory Pressure),
Chest expansion (at three levels namely axilla, nipple and xiphisternum)
Sputum quantity would be assessed by measuring the sputum volume.

(2)Physical performance: Short Physical Performance Battery test score
(3)Functional capacity : Repetitions in 30 seconds Sit to Stand test
(4)Quality of Life: EQ 5D 3L questionnaire score
 		 At Baseline
At 4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
(1)Sarcopenia using SARC-calf scale.
(2)Frailty using Fried Frailty Index.
(3)ICU acquired weakness using Medical Research Council (MRC) sum score.
 		 At Baseline
At 4 weeks 
 
Target Sample Size   Total Sample Size="36"
Sample Size from India="36" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   12/12/2022 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) -  To contact the investigator on this mail id : shrutinair@mgmcopnm.edu.in

  6. For how long will this data be available start date provided 01-03-2024 and end date provided 01-03-2027?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Respiratory dysfunction is observed in ICU survivors owing to the pathophysiological consequences resulting in retained secretion, increased airway resistance, hypoxemia, atelectasis and respiratory failure. Furthermore, retained airway secretion is considered as one of factor that delays and/ or is considered as a major predictor of extubation failure. Numerous studies support the efficacy of early physiotherapy intervention in ICU patients in improving airway clearance, ventilatory parameters such as oxygen saturation, gas exchange and lung volume as well as augment weaning and extubation success. Positive Expiratory Pressure (PEP) devices has been reported to be effective in improving pulmonary function such as airway clearance and oxygenation. AirPhysio is a validated handheld Oscillating-Positive Expiratory Pressure (O-PEP) device which helps to improve bronchial hygiene, increases lung capacity through generation of positive pressure in the airways during expiration and by optimizing collateral ventilation. However, there is dearth of literature evaluating the long-term effects of O-PEP device in ICU survivors.Thus, our study aims to assess the effect of four weeks of use of Air-Physio device on lung function, physical performance, functional capacity and Health Related of Quality of Life (HRQoL) in ICU survivors. 
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