| CTRI Number |
CTRI/2021/09/036974 [Registered on: 29/09/2021] Trial Registered Prospectively |
| Last Modified On: |
23/09/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
6 minute walk test as an index to predict the recovery after abdominal surgeries in patients with past history of Covid-19 infection. |
|
Scientific Title of Study
|
To assess preoperative six minute walk test as a predictor of quality of recovery after elective laparotomy surgery in post Covid-19 patients. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anupama Nair |
| Designation |
Post graduate Resident |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Anaesthesiology and Intensive Care,
B.L.Taneja Block,
Maulana Azad Medical College, Bahadur Shah Zafar Marg,
New Delhi.
India.
Central
DELHI
110002
India |
| Phone |
9495671426 |
| Fax |
|
| Email |
anesthesia.anupama.2020@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neelam Prasad |
| Designation |
Director Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Anaesthesiology and Intensive Care,
B.L.Taneja Block,
Maulana Azad Medical College, Bahadur Shah Zafar Marg,
New Delhi.
India.
Central
DELHI
110002
India |
| Phone |
9968604372 |
| Fax |
|
| Email |
nprasadgovil@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Neelam Prasad |
| Designation |
Director Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Anaesthesiology and Intensive Care,
B.L.Taneja Block,
Maulana Azad Medical College, Bahadur Shah Zafar Marg,
New Delhi.
India.
Central
DELHI
110002
India |
| Phone |
9968604372 |
| Fax |
|
| Email |
nprasadgovil@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Maulana Azad Medical College, New Delhi. |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesiology and Intensive Care |
| Address |
Maulana Azad Medical College, Bahadur Shah Zafar Marg, New Delhi - 110002 |
| Type of Sponsor |
Government medical college |
|
|
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 Anupama Nair |
Lok Nayak Hospital |
Department of Anaesthesiology and Intensive Care,
Maulana Azad Medical College, Bahadur Shah Zafar Marg,
New Delhi.
Central
DELHI |
9495671426
anesthesia.anupama.2020@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Maulana Azad Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: B972||Coronavirus as the cause of diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients who are recovered from Covid-19, undergoing elective laparotomy of expected duration of surgery within 3 hours.
2. Patients having a history of Covid-19 infection at least 2 months back.
3. Patients of ASA physical health status 1,2,3.
|
|
| ExclusionCriteria |
| Details |
1. Patient with significant cardiac disease (low threshold angina, severer aortic stenosis).
2. Patient with severe pulmonary disease restricting there mobility.
3. Patient having condition that prevents mobilisation for upto six minutes.
4. Pregnancy |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Prognostic value of 6 minute walk test to predict quality of recovery in patients recovered from COVID-19, undergoing elective laparotomy surgeries. |
1. After 24 hours of surgery by follow up of patient bedside in ward.
2. After 30 days of surgery. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Prognostic value of pre operative METs score as a predictor of quality of recover in post COVID-19 cases.
2. To find correlation of preoperative 6 minute walk test and METs score with quality of recovery in post COVID-19 cases. |
1. After 24 hours of surgery by follow up of patient bedside in ward.
2. After 30 days of surgery. |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
05/10/2021 |
| Date of Study Completion (India) |
22/08/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is a prospective observational study to determine how good is a pre operative 6 minute walk test to predict the Quality of Recovery in patients undergoing elective laparotomy in an adult population of 30-60 years of age, and having a past history of Covid-19 infection. This study will be conducted in Maulana Azad Medical College and associated hospitals, for a period of 1 year.
One day prior to surgery, patients enrolled for study are evaluated in ward, a relevant medical/surgical history will be taken, examined and all relevant investigation will be collected. A detailed history of past Covid-19 infection will also be asked. The procedure and purpose of the 6 minute walk test will be explained to the patients in detail. After recording the baseline vital reading, the patient is asked to walk as much as he can in 6 minutes on a straight ward corridor, at his own walking pace. While the patient walks, the examiner will monitor if patients develops any discomfort or dyspnea, for which he may need to stop in between. After taking a rest the patient is asked again to continue walking for a complete 6 minutes. At last the total distance covered by the patient in 6 minute and vitals are noted. The post operative anaesthesia risk is assessed with various parameters like METs score, RCRI score and ARISCAT score. After 24 hours of surgery, the patient is reviewed and he is asked a questionnaire, to assess the Quality of Recovery. Same questionnaire is asked to patient after one month of surgery.
Primary outcome: To see the prognostic value of pre operative 6 minute walk test to predict the Quality of Recovery in patients recovered from Covid-19, undergoing elective laparotomy surgery.
Secondary outcome: 1. Prognostic value of pre operative METs score as a predictor of the Quality of Recovery in post Covid-19 cases. 2. To find correlation of pre operative 6 minute walk test and METs score with the Quality of Recovery in post Covid-19 cases. |