CTRI Number |
CTRI/2025/03/082999 [Registered on: 20/03/2025] Trial Registered Prospectively |
Last Modified On: |
09/03/2025 |
Post Graduate Thesis |
Yes |
Type of Trial |
Observational |
Type of Study
|
Cohort Study |
Study Design |
Other |
Public Title of Study
|
To find out factors influencing post-operative ICU(intensive care unit) admissions of patients undergoing surgery. |
Scientific Title of Study
|
Factors predicting planned and unplanned postoperative intensive care unit (ICU) admissions- A Prospective Observational Study. |
Trial Acronym |
NIL |
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Ruth Tigga |
Designation |
Postgraduate Registrar |
Affiliation |
Christian Medical College Vellore |
Address |
Department of Anaesthesia, Christian Medical College, Vellore, Tamil Nadu - 632004
Vellore TAMIL NADU 632004 India |
Phone |
8557922783 |
Fax |
|
Email |
ruthtiggajc@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Balaji Kuppuswamy |
Designation |
Professor |
Affiliation |
Christian Medical College Vellore |
Address |
Department of Anaesthesia, Christian Medical College, Vellore, Tamil Nadu - 632004
Vellore TAMIL NADU 632004 India |
Phone |
04162282105 |
Fax |
|
Email |
balooswamy@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Ruth Tigga |
Designation |
Postgraduate Registrar |
Affiliation |
Christian Medical College Vellore |
Address |
Department of Anaesthesia, Christian Medical College, Vellore, Tamil Nadu - 632004
Vellore TAMIL NADU 632004 India |
Phone |
8557922783 |
Fax |
|
Email |
ruthtiggajc@gmail.com |
|
Source of Monetary or Material Support
|
Institutional Fluid Grant, Christian Medical College, Vellore, Tamil Nadu, India - 632004 |
|
Primary Sponsor
|
Name |
Institutional Fluid Grant, Christian Medical College |
Address |
Christian Medical College, Vellore, Tamil Nadu, India - 632004 |
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 Ruth Tigga |
Christian Medical College Vellore |
Department of Anaesthesia, Christian Medical College, Vellore, Tamil Nadu, India - 632004 Vellore TAMIL NADU |
8557922783
ruthtiggajc@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Review Board, Christian Medical College Vellore |
Approved |
|
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 |
NIL |
NIL |
Comparator Agent |
NIL |
NIL |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
70.00 Year(s) |
Gender |
Both |
Details |
1. Patient of either sex, aged between 18-70 years.
2. Any general surgery, orthopaedic surgery, plastic surgery, and ear-nose-throat surgeries. |
|
ExclusionCriteria |
Details |
1. Any emergency surgery.
2. Patients who are already admitted in ICU prior to surgery.
3. Any intracranial surgery or other major neurosurgical procedures.
4. Patient undergoing cardiothoracic surgeries. |
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
To determine factors predicting unplanned postoperative ICU admissions. |
24-48 hours |
|
Secondary Outcome
|
Outcome |
TimePoints |
NIL |
NIL |
|
Target Sample Size
|
Total Sample Size="1200" Sample Size from India="1200"
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)
|
24/03/2025 |
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="1" Months="4" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
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
|
Peri-operative medicine is the patient-centred and value-based multidisciplinary perioperative care of surgical patients. Unplanned ICU admissions after surgery is a quality indicator of the perioperative management. Planned postoperative intensive care unit (ICU) admission will benefit high risk patients and it is important to triage patients accordingly. The prediction is multifactorial and can be categorised as preoperative, intraoperative and postoperative factors. However, some patients may need unplanned ICU admission because of unexpected intraoperative or postoperative complications. The preoperative assessment can be done through various methods including questionnaires, formal and specialist assessment. Preoperative factors include age, body mass index and functional capacity of the patient, any significant past cardiac events or substance abuse; intraoperative factors like risk stratification of the surgery, haemodynamic stability status or any adverse perioperative event; postoperative factors include requirement of ventilatory assistance in PACU, haemodynamic instability or seizures in PACU. The aim of this study will be selecting patient groups prior to surgery which will help in adequate allocation of intensive care and better intraoperative management, especially in resource limited health care settings. This will also emphasize the need for clinical decision support tools in PACU with regard to postoperative patient allocation and patient care. |