| 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
|
|
|
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
|
|
|
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
|