| CTRI Number |
CTRI/2020/11/028841 [Registered on: 03/11/2020] Trial Registered Prospectively |
| Last Modified On: |
22/02/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Post-operative pulmonary complications after major abdominal surgery
|
|
Scientific Title of Study
|
Post-operative pulmonary complications after major abdominal surgery: A prospective observational study
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Poorva pramod more |
| Designation |
Junior resident, Department of Anaesthesiology,LTMMC |
| Affiliation |
LTMMC |
| Address |
Department of Anaesthesiology Lokmanya Tilak Muncipal
MedicalCollege and General Hospital, Sion, Mumbai
Mumbai
MAHARASHTRA
400022
India |
| Phone |
9167645894 |
| Fax |
|
| Email |
poorvamore.pm@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ruchi jain |
| Designation |
Assistant professor, Department of Anaesthesiology,LTMMC |
| Affiliation |
LTMMC |
| Address |
Department of Anaesthesiology Lokmanya Tilak Muncipal
MedicalCollege and General Hospital, Sion, Mumbai
Mumbai
MAHARASHTRA
400022
India |
| Phone |
9619419983 |
| Fax |
|
| Email |
ruchiajain@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Poorva pramod more |
| Designation |
Junior resident, Department of Anaesthesiology,LTMMC |
| Affiliation |
LTMMC |
| Address |
Department of Anaesthesiology Lokmanya Tilak Muncipal
MedicalCollege and General Hospital, Sion, Mumbai
Mumbai
MAHARASHTRA
400022
India |
| Phone |
9167645894 |
| Fax |
|
| Email |
poorvamore.pm@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Poorva pramod more |
| Address |
Department of Anaesthesiology Lokmanya Tilak Muncipal
MedicalCollege and General Hospital, Sion, Mumbai
|
| Type of Sponsor |
Other [Self] |
|
|
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 Poorva pramod more |
Lokmanya Tilak Muncipal Medical College and GeneralHospital |
Department of anaesthesia,fourth floor,college building,ltmgh, Sion,
Mumbai-400022
Mumbai
MAHARASHTRA |
9167645894
poorvamore.pm@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee-human research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K319||Disease of stomach and duodenum, unspecified, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
All adult patients who undergo elective or emergency major abdominal surgery under GA or GA and RA |
|
| ExclusionCriteria |
| Details |
1 patient not consenting
2 younger tajn 18years
3 obstetric procedure or any procedure during pregnancy
4 procedures related to previous surgical complications
5 organ transplantation |
|
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Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
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Primary Outcome
|
| Outcome |
TimePoints |
1.To find out the incidence of PPC in patients undergoing major abdominal surgery.
2.To find factors associated with the development of PPC after major abdominal surgery
|
4 week
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1Assessment and comparison of ARISCAT and LAS VEGAS score in predicting PPC
2 In- hospital mortality due to PPC
3 Post operative ICU admission for PPC
4 Post operative length of stay
30 day mortality
|
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="400"
Sample Size from India="400"
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 3 |
|
Date of First Enrollment (India)
|
15/11/2020 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
In this study patients who are posted for elective or emergency major abdominal surgery, satisfying all inclusion and exclusion criteria,will be included.All patients or their next of kin will be explained about the study and a written valid informed consent for their willingness to participate in the study will be taken. This will be a pragmatic study with no change in routine clinical practice.The choice of anaesthetic agents, muscle relaxants,perioperative analgesia will be decided by anesthesiologist conducting the case.The decision regarding extubation and poste operative management will be taken by the anesthesiologist and surgeons as per routine clinical or practice The baseline characteristics including age of patient,ASA grading,sex will be noted During intraoperative period technique of ventilation, ventilator settings will be noted, intraoperative hypotension and desaturation and administration of unplanned vasoactive drugs will be recorded. PPCs will be clinically observed and recorded daily from day of surgery until discharge from hospital or until postoperative day 7 whichever comes first.Each adverse pulmonary event will be recorded dail.Length of hospital stay and in hospital mortality will be determined from patients records or telephonically at postoperative day 30 |