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CTRI Number  CTRI/2024/03/063778 [Registered on: 07/03/2024] Trial Registered Prospectively
Last Modified On: 06/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [educational]  
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Role of demonstrational video in performing acceptable spirometry. 
Scientific Title of Study   A randomized control trial to compare the time taken to perform acceptable spirometry between two groups after providing procedural demonstrational video with routine instructions versus only routine instructions.  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ansa Grace Koshy 
Designation  PG Registrar 
Affiliation  Christain Medical College Hospital, Vellore 
Address  Dr Ansa Grace Koshy Department of Respiratory Medicine CMC Vellore – 632004 Phone no – 8281137016 Email – ansagrace94@gmail.com

Vellore
TAMIL NADU
632004
India 
Phone  8281137016  
Fax    
Email  ansagrace94@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. Richa Gupta 
Designation  Professor and Head of department 
Affiliation  Christain Medical College Hospital, Vellore 
Address  Dr. Richa Gupta Professor and Head Department of Respiratory Medicine CMC Vellore – 632004 Phone no – 9600771705 Email – drricha21@gmail.com

Vellore
TAMIL NADU
632004
India 
Phone  9600771705  
Fax    
Email  drricha21@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Ansa Grace Koshy 
Designation  PG Registrar 
Affiliation  Christain Medical College Hospital, Vellore 
Address  Dr Ansa Grace Koshy Department of Respiratory Medicine CMC Vellore – 632004 Phone no – 8281137016 Email – ansagrace94@gmail.com


TAMIL NADU
632004
India 
Phone  8281137016  
Fax    
Email  ansagrace94@gmail.com  
 
Source of Monetary or Material Support  
Internal - fluid research grant Christian Medical College Vellore Research Office Carman Block, Bagayam, Vellore 632002  
 
Primary Sponsor  
Name  None 
Address  None 
Type of Sponsor  Other [None] 
 
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 
Dr Ansa Grace Koshy  Christian Medical College  Pulmonary Function Test Lab Department of Respiratory Medicine Christian Medical College Vellore - 632004
Vellore
TAMIL NADU 
8281137016

ansagrace94@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL REVIEW BOARD, CHRISTIAN MEDICAL COLLEGE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Obstructive airway disease 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Spirometry with demonstrational video  Providing demonstrational video prior to procedure along with routine instructions. The demonstrational video will be shown 15 minutes before the procedure in a group of three to maximum five people per day from the first group of population. This will be shown by the investigators. It will be shown maximum of 3 times for each person ( video of 1min 30sec).  
Comparator Agent  Spirometry with routine instructions  Spirometry with routine instructions 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  All patients, aged more than 18 years who are referred for spirometry ( who are undergoing spirometry for the first time) 
 
ExclusionCriteria 
Details  Patients with

Acute myocardial infarction within 1 week

Systemic hypotension or severe failure

Uncontrolled pulmonary hypertension

Acute corpulmonale

Clinically unstable pulmonary embolism

History of syncope related to forced expiration/cough

Cerebral aneurysm, Brain surgery within 4 week
, recent concussion with continuing symptoms, eye surgery within 1 week

Sinus surgery or middle ear surgery or infection within 1 week

Presence of pneumothorax, thoracic surgery within 4 week, abdominal surgery within 4 week

Late-term pregnancy

Active or suspected transmissible respiratory or systemic infection, including tuberculosis
 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To study the time taken for performing acceptable quality spirometry test after providing demonstrational video prior to the procedure along with standard instructions to one group versus only standard instructions.  Baseline 
 
Secondary Outcome  
Outcome  TimePoints 
: 1. To compare the number of attempts taken for performing acceptable quality spirometry test between both groups.
2. To compare the easiness of performing acceptable quality spirometry test for respiratory therapists in both groups.
3. To compare the easiness of performing acceptable quality spirometry test for patients in both groups.
 
Baseline 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
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)   20/03/2024 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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  

Spirometry is a physiological test used to measure an individual’s maximum air volume during inhalation and exhalation with full effort. The test primarily focuses on measuring either volume or airflow over time. However, ensuring the quality of these tests is crucial. It requires accurate equipment, patient cooperation, and optimal effort. Registered respiratory therapists (RRTs) and pulmonary function laboratory personnel play a vital role in coaching patients for optimal performance. However, performing spirometry tests can be challenging, particularly with new patients, young children, and the elderly. This difficulty, coupled with the need for multiple attempts to achieve quality results, limits the utility of spirometry in many countries.

 

To address these challenges, providing patients with descriptive information pamphlets or demonstrational videos prior to testing can help prepare them for the procedure. The testing process typically involves instructing the patient on the correct technique, demonstrating the procedure, conducting the test, assessing its acceptability and repeatability, and providing feedback to improve the patient’s technique if necessary. Inconsistent patient effort has been observed to introduce greater variability in pulmonary function test measurements compared to other medical tests. Inadequate instruction and coaching by pulmonary function laboratory personnel contribute to inconsistent patient effort.

 

The aim of our randomized controlled trial is to assess whether providing patients with a demonstrational video in their native language prior to the spirometry test can improve its success rate with fewer attempts. This approach aims to make the test easier for both the patient and the instructor, ultimately improving the overall quality and efficiency of spirometry testing

 

 
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