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CTRI Number  CTRI/2025/09/094948 [Registered on: 16/09/2025] Trial Registered Prospectively
Last Modified On: 12/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Improvement in breathing after ICU stay: Role of breathing exercise 
Scientific Title of Study   Efficacy of inspiratory muscle training on maximal inspiratory pressure and dyspnea among post-weaned adult patients at tertiary care center, South India – a randomized controlled trial  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Jeyaveeranan N 
Designation  MSc Nursing Student 
Affiliation  Jawaharlal Institute of Postgraduate Medical Education and Research 
Address  No. 206, College of Nursing, JIPMER
No. 206, College of Nursing, JIPMER
Pondicherry
PONDICHERRY
605006
India 
Phone  9952554674  
Fax    
Email  jeyaveeran440@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Aruna P 
Designation  Tutor 
Affiliation  Jawaharlal Institute of Postgraduate Medical Education and Research 
Address  No. 206, College of Nursing, JIPMER
No. 206, College of Nursing, JIPMER
Pondicherry
PONDICHERRY
605006
India 
Phone  8098523408  
Fax    
Email  prabha.prathibha@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Aruna P 
Designation  Tutor 
Affiliation  Jawaharlal Institute of Postgraduate Medical Education and Research 
Address  No. 206, College of Nursing, JIPMER
No. 206, College of Nursing, JIPMER
Pondicherry
PONDICHERRY
605006
India 
Phone  8098523408  
Fax    
Email  prabha.prathibha@yahoo.com  
 
Source of Monetary or Material Support  
Jawaharlal Institute of Postgraduate Medical Education and Research 
 
Primary Sponsor  
Name  Jawaharlal Institute of Postgraduate Medical Education and Research 
Address  JIPMER Campus Rd, Gorimedu, Dhanvantari Nagar, Puducherry, 605006 
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Jeyaveeranan N  Jawaharlal Institute of Postgraduate Medical Education and Research   Room no: 41, Medical Intensive Care Unit, Medicine Department
Pondicherry
PONDICHERRY 		 9952554674

jeyaveeran440@gmail.com 
Jeyaveeranan N  Jawaharlal Institute of Postgraduate Medical Education and Research  Rooom no: 28, Pulmonary Intensive Care Unit, Respiratory Medicine Department
Pondicherry
PONDICHERRY 		 9952554674

jeyaveeran440@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee (Human Studies) JIPMER  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, (2) ICD-10 Condition: J99||Respiratory disorders in diseasesclassified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Inspiratory Muscle Training  Extubated patients receive routine post-weaned care along with Maximal Inspiratory Pressure (MIP), which will be assessed by first instructing participants to fully exhale, followed by a forceful inhalation through the device for at least 2 seconds. The baseline MIP will be recorded from the device. The procedure will be explained and demonstrated to each participant. MIP measurements will taken twice daily for 5 consecutive days after the intervention. 
Comparator Agent  Standard care group  After extubation, patients will be treated as routine post-weaned care 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  Patients weaned from the mechanical ventilator who were on mechanical ventilation for at least 7 days
Aged more than 18 years and both Gender
GCS more than 13
After 3-5 hours of extubation, volitional MIP of -20 to -80 cms of water for 2 seconds 
 
ExclusionCriteria 
Details  Hemodynamically unstable
Acute cerebrovascular accident
Acute delirium
Spontaneous pneumothorax
Rib fracture
Cervical spine fracture
Pregnancy
Recent abdominal surgery
Tracheostomised patients
 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess the efficacy of inspiratory muscle training combined with standard care compared to standard care alone on maximal inspiratory pressure and dyspnea.  1. MIP
6 time points
Baseline, Post-Intervention (Evening) from Day 1 to Day 5
2. Dyspnea
2 time point
Baseline and Postintervention (Day 5) 
 
Secondary Outcome  
Outcome  TimePoints 
• To compare the re-intubation incidence ratio between the intervention and standard care groups.
• To compare the severity of illness and length of stay after extubation between the intervention and standard care groups. 		 2 time points
Baseline and Post-intervention (Day 5) 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   20/09/2025 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

The study will be conducted at JIPMER in the Medical Intensive Care Unit (MICU), Pulmonary Medicine ICU, Medicine Ward, and Ward 27 after obtaining approvals from the Institutional Ethics Committee and the JIPMER Nursing Research Monitoring Committee. Participants who meet the inclusion criteria will be selected using a convenience sampling method, and data collection will take place over a period of a year. A pilot study will be carried out following the necessary approvals. Participants will be enrolled 3 to 5 hours after extubation, and written informed consent will be obtained after providing adequate information using a participant information sheet. Demographic and clinical variables will be collected through a structured subject data sheet. Based on gender, participants will be stratified and randomly allocated into study groups.

Baseline maximal inspiratory pressure (MIP) will be assessed by instructing participants to exhale fully and then perform a forced inhalation through a respiratory muscle training device. MIP will be recorded for five consecutive days. The severity of dyspnea will be measured using the Respiratory Distress Observation Scale (RDOS), which includes monitoring heart rate, respiratory rate, breathing patterns (paradoxical breathing, use of accessory muscles, grunting, nasal flaring), and facial expressions (restlessness, look of fear). RDOS will be assessed at baseline and again after completing 10 intervention sessions.

The intervention involves a breathing exercise where participants exhale completely, inhale through the device, and then exhale slowly using pursed-lip breathing. Each session will include five sets of six breaths (a total of 30 breaths per session), provided twice daily for five days, totaling 10 sessions. A trained person will record the MIP after each day’s second session, and RDOS will be reassessed after the final session. Participants will be followed until discharge, and the length of hospital stay will be documented. The total duration required for each participant in the intervention group is approximately six minutes per day and 32 minutes over five days. In contrast, the standard care group will require only one minute per session, totaling 12 minutes over five days.

 
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