| CTRI Number |
CTRI/2025/06/089867 [Registered on: 30/06/2025] Trial Registered Prospectively |
| Last Modified On: |
30/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Other |
|
Public Title of Study
|
Exercise program and nutritional therapy for optimizing post operative pulmonary outcomes in patients undergoing upper abdominal surgeries. |
|
Scientific Title of Study
|
Targeted Prehabilitation based on PEFR thresholds for optimizing post operative pulmonary outcomes in patients undergoing upper abdominal surgeries. |
| Trial Acronym |
Targeted Prehabilitation based on PEFR thresholds for optimizing post operative pulmonary outcomes in patients
undergoing upper abdominal surgeries: A Prospective interventional study |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Meghana P |
| Designation |
Post graduate in Department of Anaesthesiology |
| Affiliation |
Rajarajeshwari Medical College and Hospital |
| Address |
Department of Anesthesiology, Rajarajeshwari Medical College and Hospital, Mysore road, Kambipura, Bangalore, Karnataka
Bangalore KARNATAKA 56074 India |
| Phone |
9945228822 |
| Fax |
|
| Email |
meghana948@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Sowmya M Jois |
| Designation |
Associate Professor |
| Affiliation |
Rajarajeshwari Medical College and Hospital |
| Address |
Department of Anesthesiology, Rajarajeshwari Medical College and Hospital, Mysore road, Kambipura, Bangalore, Karnataka
Bangalore KARNATAKA 560074 India |
| Phone |
9980891082 |
| Fax |
|
| Email |
Drsowmyasharma@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Sowmya M Jois |
| Designation |
Associate Professor |
| Affiliation |
Rajarajeshwari Medical College and Hospital |
| Address |
Department of Anesthesiology, Rajarajeshwari Medical College and Hospital, Mysore road, Kambipura, Bangalore, Karnataka
Bangalore KARNATAKA 560074 India |
| Phone |
9980891082 |
| Fax |
|
| Email |
Drsowmyasharma@gmail.com |
|
|
Source of Monetary or Material Support
|
| Departement of Anaesthesiology, Rajarajeshwari Medical College and Hospital, Mysore road, Kambipura, Bangalore, Karnataka |
|
|
Primary Sponsor
|
| Name |
Dr Meghana P |
| Address |
Departement of Anaesthesiology, Rajarajeshwari Medical College and Hospital, Mysore road, Kambipura, Bangalore, Karnataka 560074 |
| Type of Sponsor |
Private 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 Meghana P |
Departement of Anaesthesiology, Rajarajeshwari medical college and hospital. |
2nd floor Hospital Building, Departement of Anaesthesiology, Rajarajeshwari Medical College and Hospital, Mysore road, Kambipura, Bangalore, Karnataka Bangalore KARNATAKA |
9945228822
meghana948@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTE |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
PEFR on post operative day 1 |
PEFR will be measured on post operative day 1 and will be compared with PEFR before surgery to check whether there’s any improvement in PEFR due to Prehabilitation |
| Comparator Agent |
PEFR pre operative day |
PEFR will be measured on pre operative day and will be compared with PEFR on post operative day 1 to see improvement with Prehabilitation |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
a) ASA I, II, III patients of either sex.
b) Patients aged between 18 to 75 years.
c) Patients undergoing elective upper abdominal and thoracic surgeries under
general anesthesia resulting in a minimum hospital stay of at least 2 days, excluding day case surgery
d) Patients willing to participate in this study. |
|
| ExclusionCriteria |
| Details |
a) Patients not willing to participate in this study.
b) Patients with ASA grade IV
c) Patients undergoing emergency surgeries
d) Inability to perform PEFR
e) Baseline PEFR <30% of predicted values.
f) Recent hospitalization for severe illness (<6months).
g) Body mass index in >30kg/m2 |
|
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Method of Generating Random Sequence
|
|
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Method of Concealment
|
|
|
Blinding/Masking
|
|
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Primary Outcome
|
| Outcome |
TimePoints |
Primary Objective is to evaluate the effectiveness of PEFR guided Prehabilitation in reducing the
incidence of post operative pulmonary complications (pneumonia, post
operative ventilation, atelectasis, desaturation, requirement of O2 therapy
post operatively).
and Improving functional recovery in patients undergoing elective upper
abdominal surgeries. |
Pre operative day 3, 2, 1 and Post operative day 1 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in PEFR from preoperative visit to the day after surgery and Duration of hospital stay and any ICU admission. |
Post operative day 1 |
|
|
Target Sample Size
|
Total Sample Size="42" Sample Size from India="42"
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
|
Phase 1 |
|
Date of First Enrollment (India)
|
15/07/2025 |
| 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="0" 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
|
Targeted Prehabilitation focusing on respiratory optimization has shown promise in reducing post operative complications.Peak expiratory flow rate (PEFR) is a simple and reliable measure of airway obstruction and Pulmonary function, and it can be used to serve as an essential tool for tailoring Prehabilitation programmes. Prehabilitation is a multidisciplinary healthcare intervention including exercise, nutritional optimization, and psychological preparation, to dampen the metabolic response to surgery, better withstand a stressful event, shorten the period of recovery, reduce complications, and improve the quality of recovery and quality of life. During upper abdominal surgeries, intraoperative changes in pulmonary function occur due to decreased lung compliance. In our study, 42 patients of ASA I, II, III aged between 18 and 75 years scheduled for elective surgeries under general anaesthesia will be selected based on inclusion or exclusion criteria. They will be categorized into Mildly reduced PEFR and Severely reduced PEFR. Patients will receive targeted PEFR guided Prehabilitation. During Preoperative checkup PEFR will be done using Peak flow meter. PEFR will be measured with a portable device, the Mini Portable Peak Flow Meter ranging from 60 to 800 l/min, according to the Guidelines for Pulmonary Function Tests, 2002, with the patient sitting. Patients will be instructed to exert a maximal inspiration to total lung capacity followed by a maximal, short and explosive forced expiration through the measuring device, without extending the measure to residual volume. The expiratory effort needed last only a second or two. Test will be repeated the test three times, considering the best result if the readings did not differ more than 20 ml/ min from each other. After performing, patients will be classified into 2 categories, i.e, mildly reduced PEFR (60-80%) and severely reduced PEFR (less than 60%). Mildly reduced PEFR group will receive following interventions without supervision at home or in hospital during their stay: Psychological preparation, Dietitian suggested meals with good sugar control, Smoking cessation, Deep breathing exercises that include Incentive spirometry, Aerobic exercises, Coughing and huffing exercises. Severely reduced PEFR group will receive above mentioned interventions as well as extra interventions like the following: Assisted Physiotherapy and Bronchodilator therapy. Both groups will be counseled and prepared psychologically as to why Pre Operative preparation is important. Dietician opinion will be provided regarding the diet they have to follow Preoperatively. Patients who smoke cigarettes or beedis will be advised to stop smoking. They will be made to part in a training program 3 sessions for 3 days before surgery designed to improve the strength and endurance of the inspiratory muscles. A daily diary will be given to each participant to follow up on both exercise training and nutrition requirements so as to evaluate the effectiveness of Prehabilitation in reducing the incidence of post operative pulmonary complications and improvement in PEFR from preoperative visit to the day after surgery, duration the course of hospital stay and ICU admission (if any). |