| CTRI Number |
CTRI/2018/02/012124 [Registered on: 23/02/2018] Trial Registered Retrospectively |
| Last Modified On: |
22/02/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Factors which may be associated with increased chances of breathing problems after surgery |
|
Scientific Title of Study
|
Peri-operative risk factors for pulmonary complications after non-cardiac surgery |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Radhika Dhanpal |
| Designation |
Professor |
| Affiliation |
Vydehi Institute of Medical Sciences, Bangalore |
| Address |
2 EPIP area, Whitefield Bangalore, Karnataka
Bangalore
KARNATAKA
560066
India |
| Phone |
9980506707 |
| Fax |
|
| Email |
radhika.dhanpal@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Surbhi Gupta |
| Designation |
Associate Professor |
| Affiliation |
St. Johns Medical College and Hospital,Bangalore |
| Address |
Dept. of Anaesthesiology and Critical Care Medicine
St.Johns Medical College Bangalore
Bangalore
KARNATAKA
560034
India |
| Phone |
9880109361 |
| Fax |
|
| Email |
surbhi_pg@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Surbhi Gupta |
| Designation |
Associate Professor |
| Affiliation |
St. Johns Medical College and Hospital, Bangalore |
| Address |
Dept. of Anaesthesiology and Critical Care Medicine
St.Johns Medical College Bangalore
Bangalore
KARNATAKA
560034
India |
| Phone |
9880109361 |
| Fax |
|
| Email |
surbhi_pg@yahoo.com |
|
|
Source of Monetary or Material Support
|
| No monetary support was sought |
|
|
Primary Sponsor
|
| Name |
Radhika Dhanpal and Surbhi Gupta |
| Address |
St. Johns Medical College and Hospital Bangalore |
| 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 |
| Radhika Dhanpal |
St Johns Medical College and Hospital |
2nd floor Operation theater complex, Department of Anaesthesiology
Bangalore
KARNATAKA |
9980506707
radhika.dhanpal@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee St Johns Medical College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Posted for Surgery, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. under general anaesthesia
2. under regional anaersthesia
3. under neuraxial block
4. non-cardiac surgey |
|
| ExclusionCriteria |
| Details |
1. age less than 18 years
2. obsteteric procedures
3. procedures related to a previous post-operative complications
4.transplantation procedures
5.patient with pre-intubated trachea
6. out patient procedure (hosptital stay less than 24 hrs)
7. morbidly obese |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine peri-operative risk factors for pulmonary complications after non-cardiac surgery |
Patients were followed up every day till the day they were discharged from the hospital |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Patients who were re-explored had higher incidence of post-operative complications |
1 month |
|
|
Target Sample Size
|
Total Sample Size="1170"
Sample Size from India="1170"
Final Enrollment numbers achieved (Total)= "1170"
Final Enrollment numbers achieved (India)="1170" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/03/2016 |
| Date of Study Completion (India) |
30/09/2016 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="30" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
No publication |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
59
out of 1170 patients developed postoperative pulmonary complications (PPCs).
Univariate
analysis showed that the presence of anemia
(hemoglobin < 10 gm%) ,
positive cough test, type of surgery as emergency surgery, type of
anesthesia as general anaesthesia , increased duration of surgery (> 2 hours), presence of preoperative nasogastric tube,
intraoperative blood transfusion, higher patient age (>50 years), presence
of preoperative respiratory symptoms (cough, sputum, dyspnea) and increased ARISCAT score were
significantly associated with the presence of postoperative pulmonary
complications.
Multivariate
analysis revealed that higher ARISCAT score and patients with higher age had
higher odds of developing PPC. Patients who had positive cough test and
presence of preoperative nasogastric
tube were other independent risk factors associated with the presence of PPC.
|