| CTRI Number |
CTRI/2024/11/076704 [Registered on: 12/11/2024] Trial Registered Prospectively |
| Last Modified On: |
24/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA)
Other (Specify) [Pulmonary prehabilitation ] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of chest physiotherapy prior to surgery for mouth cancer. |
|
Scientific Title of Study
|
Effect of pulmonary prehabilitation on post-operative pulmonary complications in patients undergoing surgery for oral cancer: A randomized control study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shruthi Patil V |
| Designation |
Mch registrar |
| Affiliation |
Christian medical college |
| Address |
Department of Head and neck surgery, HNS office, Paul brand buidling,2nd floor,
Christian medical college Town campus, Christian medical College
Department of head and neck surgery, Christian medical college campus, Christian medical College
Vellore
TAMIL NADU
632004
India |
| Phone |
9663138858 |
| Fax |
|
| Email |
Shruthispv@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Konduru Vidya |
| Designation |
Associate professor |
| Affiliation |
Christian medical college |
| Address |
Department of head and neck surgery, Paul band building, 2nd floor,
Christian medical college campus, Christian medical College
Christian medical college campus, Christian medical College
Vellore
TAMIL NADU
632004
India |
| Phone |
9663138858 |
| Fax |
|
| Email |
vidya5feb@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shruthi Patil V |
| Designation |
Mch registrar |
| Affiliation |
Christian medical college |
| Address |
Department of head and neck surgery, Paul brand buidling, 2nd floor Christian medical College
Christian medical college campus, Christian medical College
Vellore
TAMIL NADU
632004
India |
| Phone |
9663138858 |
| Fax |
|
| Email |
Shruthispv@gmail.com |
|
|
Source of Monetary or Material Support
|
| Christian medical college, Vellore, 632004, Tamilnadu state, India. |
|
|
Primary Sponsor
|
| Name |
Christian medical college and hospital |
| Address |
Christian medical college and hospital,Vellore-632004
Tamilnadu state
India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Shruthi Patil |
Christian medical college and hospital |
Department of head and neck surgery,
Head and neck surgery unit 2 -OPD and ward.
Christian medical college Town campus, Vellore
Vellore
TAMIL NADU |
9663138858
Shruthispv@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board, CMC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C069||Malignant neoplasm of mouth, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Inspiratory muscle training (IMT) |
All patients in the intervention arm will undergo respiratory drive test prior to IMT to assess their respiratory capacity and to have baseline values.
Respiratory physiotherapist will teach the inspiratory muscle training(IMT) exercises using IMT device (every patient will buy IMT device using the funds provided by hospital for study).
Intervention details: Patients are advised to do IMT exercises for 15 minutes, twice daily for 2 weeks. Patients will be assessed after 1 week to know whether the patient is compliant or not and the technique of exercise is being done correctly or not.
At the end of 2 weeks of IMT training, repeat respiratory drive test will be done to assess the respiratory capacity again and all patients will undergo surgery as per schedule without any delay.
|
| Comparator Agent |
Standard post-operative care |
Standard post-operative care in our unit includes:
a) Head end elevation by 30-45 degrees
b) Oral care with chlorhexidine mouth wash 4th hourly
c) Chest physiotherapy from POD 1
d) Incentive spirometry from POD 1, around 3-4 times a day
e) Antibiotic
f) Oxygen supplementation at 4 litres/min by face mask for 12-24 hours post-operatively.
g) Initiation or withholding of oral feeds depending on oral wound status and risk of aspiration.
h) Swallowing exercises, as required based on extent of surgery and type of reconstruction.
i) Standard surgical nursing care in terms of ambulation, catheter care, back care and general hygiene.
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1) Age between 18 to 90 years
2) Patients consenting for the study
3) Biopsy proven oral cancer, undergoing surgery as the primary modality of treatment with curative intent.
4) Duration of surgery more than 3 hours
|
|
| ExclusionCriteria |
| Details |
b. Exclusion Criteria:
1. Patients with preexisting cardiopulmonary comorbidities.
2. Patients with functional dependence for daily activities.
3. Surgery causing oral incompetence which makes incentive spirometry difficult.
4. Patients with tracheostomy or requiring tracheostomy during surgery.
5. Patients undergoing salvage surgery for recurrence.
6. Patients undergoing emergency surgery for re-exploration or second surgery.
7. Patients unable to follow instructions in IMT or the patient information sheet.
8. Patients in whom IMT is contraindicated
a) History of spontaneous pneumothorax
b) Traumatic pneumothorax that has not fully healed
c) Burst eardrum or other conditions of the eardrum
d) Unstable asthma with an abnormally low perception of dyspnoea.
|
|
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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 determine the incidence of post-operative pulmonary complications in patients undergoing surgery for oral cancer with or without pulmonary prehabilitation. |
From the time of hospital admission till discharge. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine the utility of the existing scoring system ARISCAT as a predictor of post- operative pulmonary complications following surgery for oral cancer. |
ARISCAT scoring will be calculated at 8 weeks of recruitment into study. |
|
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Target Sample Size
|
Total Sample Size="92"
Sample Size from India="92"
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)
|
01/12/2024 |
| 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="7" |
|
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 - YES
- 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).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response (Others) - Princpal investiigaor, Guide, Institutional review board and ethical committee, Journal publication peer reviewers
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [Shruthispv@gmail.com].
- For how long will this data be available start date provided 01-09-2024 and end date provided 01-09-2029?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
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Brief Summary
|
Post-operative pulmonary complications(PPC) are defined as any complications affecting the respiratory system after anaesthesia and surgery. Their incidence after major surgery varies widely, from <1% to 23%. PPC are more common than cardiac complications and account for significantly increased length of stay and cost.
|