| CTRI Number |
CTRI/2024/03/064931 [Registered on: 28/03/2024] Trial Registered Prospectively |
| Last Modified On: |
27/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study to observe the relationship between Perfusion index and core body temperature. |
|
Scientific Title of Study
|
Correlation between Perfusion Index and Perioperative body
temperature – 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 |
Dr Abirami M |
| Designation |
PG Registrar |
| Affiliation |
Department of Anesthesia |
| Address |
Room no - 945, LIQ,
Christian medical college,
Vellore.
Christian medical college,
Ida scudder road,
Vellore.
Vellore
TAMIL NADU
632004
India |
| Phone |
9159564343 |
| Fax |
|
| Email |
drabirami09@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bernice Theodore Y |
| Designation |
Associate Professor |
| Affiliation |
Department of Anesthesia |
| Address |
Department of Anesthesia
Christian Medical college
Vellore
Christian medical college,
Ida scudder road, Vellore.
Vellore
TAMIL NADU
632004
India |
| Phone |
9486843882 |
| Fax |
|
| Email |
berniceranjan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Abirami M |
| Designation |
PG Registrar |
| Affiliation |
Department of Anesthesia |
| Address |
Room no. 945, LIQ, Christian medical college, Vellore.
Christian medical college,
Ida scudder road,
Vellore
Vellore
TAMIL NADU
632004
India |
| Phone |
9159564343 |
| Fax |
|
| Email |
drabirami09@gmail.com |
|
|
Source of Monetary or Material Support
|
| Internal - Fluid research Grant, Christian medical college, Vellore. |
|
|
Primary Sponsor
|
| Name |
Internal Fluid Research Grant |
| Address |
Christian Medical College Vellore
Ida Scudder Road, Vellore 632 004 – Tamil Nadu
|
| 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 ABIRAMI M |
Christian medical college |
OR - 17,18,19,20,21,
Surgery OR, Main campus,
Department of Anesthesia.
Vellore
TAMIL NADU |
9159564343
drabirami09@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHICS COMMITTEE BLUE,OFFICE OF RESEARCH, INSTITUTIONAL REVIEW BOARD (IRB), CHRISTIAN MEDICAL COLLEGE, VELLORE. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K918||Other intraoperative and postprocedural complications and disorders of digestive system, |
|
|
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) Patients in the age group 18 – 70 years undergoing elective minimally invasive abdominal surgeries
2) Patients belonging to ASA Criteria 1 and 2 |
|
| ExclusionCriteria |
| Details |
1) body mass index (BMI) less than 20 or more than 30
2) Age less than 19 years or more than 70 years
3) American Society of Anaesthesiologists physical status (ASA-PS) score more than or equal to 3
4) Patients with peripheral vascular disease or vasculitis
5) Baseline temperature less than 36 C
6) Surgeries which get converted to open abdominal surgeries
7) Patients requiring ionotropic supports |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Perfusion index is measured by pulse oximetry, core body temperature is measured preoperatively by tympanic thermometer and intraoperatively by rectal temperature probe. Perfusion index and Core body temperature are correlated. |
During Induction and Maintenance of anesthesia |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To determine the cut off value of perfusion index before induction and ratio of PI
variation at 30 mins after induction which can predict intraoperative redistributive
hypothermia |
During induction and maintenance of anesthesia |
|
|
Target Sample Size
|
Total Sample Size="147"
Sample Size from India="147"
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)
|
05/04/2024 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Hypothermia is defined by a low core body temperature less than 35˚C with more conservative perioperative thresholds of 36˚C. It is estimated that 50 – 90% of patients experience hypothermia during surgery. Perioperative hypothermia affects various organ systems and alter several physiological functions. These include, sympathetic nervous system activation, impaired platelet function and coagulation cascade, postoperative shivering, blunted ventilatory response to carbon dioxide, systemic and pulmonary vasoconstriction and increased arterial blood pressure, variations in serum potassium levels, impaired neutrophils and macrophages and altering the pharmacokinetic of drugs. It may lead to increased intraoperative blood loss and transfusion, surgical site infections, cardiac events, reduced clearance of drugs and prolonged action of neuromuscular blockers, increased need for mechanical ventilation and longer duration of hospital stay. These adverse effects can be minimized by prevention, treatment and increased awareness of the problems due to hypothermia. Pulse oximetry is simple, continuous, noninvasive monitor which displays peripheral oxygen saturation and heart rate using plethysmography technology. Peripheral perfusion index (PPI) is another variable measured by pulse oximetry, which is the ratio of pulsatile flow to the non-pulsatile flow of blood in the peripheral circulation. Its normal value ranges from 0.02% (weak pulse) to 20% (strong pulse). Lower values indicate vasoconstriction and higher values indicate vasodilation. It is affected by two main determinants: cardiac output and balance between sympathetic and parasympathetic nervous systems(5). Redistribution hypothermia is the main cause of potential perioperative hypothermia. It is due to vasodilation, impaired function of hypothalamus and limited body’s ability to cause vasoconstriction, mediated by general anesthesia. Changes in PPI are noted due to vasodilation and body temperature redistribution in association with general anesthesia. Hence, the aim of our study is to identify the relationship between perfusion index and core body temperature and its role in predicting perioperative hypothermia. |