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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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