| CTRI Number |
CTRI/2016/10/007418 [Registered on: 27/10/2016] Trial Registered Prospectively |
| Last Modified On: |
27/10/2016 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
A study to compare two techniques of warming the patient with warm air (starting warming 1 h before anesthesia and starting warming with start of anesthesia) to prevent reduction in patients body temperature during the surgery |
|
Scientific Title of Study
|
A prospective randomized comparative study between prewarming and cowarming to prevent intraoperative hypothermia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
N Kalyan |
| Designation |
Resident Anesthesiologist |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Anaesthesiology,
Main OT Complex, first floor
Kasturba Hospital
Kasturba Medical College
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
|
| Fax |
|
| Email |
kalyann45@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Krishna HM |
| Designation |
Professor |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Anaesthesiology,
Main OT Complex,
Kasturba Hospital,
Kasturba Medical College
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
|
| Fax |
|
| Email |
hmkrishna20032002@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Krishna HM |
| Designation |
Professor |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Anaesthesiology,
Main OT Complex, First floor,
Kasturba Hospital
Kasturba Medical College
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
|
| Fax |
|
| Email |
hmkrishna20032002@gmail.com |
|
|
Source of Monetary or Material Support
|
| MANIPAL UNIVERSITY,
University Building first floor,
Manipal,
Karnataka State. 576104 |
|
|
Primary Sponsor
|
| Name |
Kasturba Hospital Kasturba Medical College Manipal |
| Address |
Department of Anaesthesiology,
Main OT Complex, first floor,
Kasturba Medcial College, Manipal |
| Type of Sponsor |
Research institution and hospital |
|
|
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 N Kalyan |
Kasturba Hospital |
OT COMPLEX, Department of Anesthesiology, First floor, KASTURBA HOSPITAL, MANIPAL, KARNATAKA
Udupi
KARNATAKA
Udupi
KARNATAKA |
9663394716
kalyann45@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, KASTURBA HOSPITAL, MANIPAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patients undergoing elective laparotomy under general anaesthesia with expected duration of more than 2 hrs, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
cowarming |
Full body (except the face) convective warming will be started as soon as the patient is shifted into the operating room (Equator convective body warmer set to a output of 45°c). Only then monitoring will be established, intravenous access will be secured and induction of anesthesia will begin. Warming continues into the intraoperative period over the available body surface area. |
| Intervention |
Prewarming |
patients are prewarmed for one hour before the induction of anesthesia in the preoperative holding area using Equator convective body warmer and full body warming blanket covering all the body parts except the face. Patients will be prewarmed with temperature output of the warming unit set to 45°c for 60 min. Warming will continue during induction of anesthesia and the surgery. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1) adult patients of either gender
2) age 18 to 65 years
3) ASA physical status 1 and 2
4) Body mass index of 18.5 to 25
5) undergoing elective laparotomy under general anaesthesia with expected duration of more than 2 hrs. |
|
| ExclusionCriteria |
| Details |
1. Patients suffering from endocrine disorders like thyroid disease, dysautotonia , Cushing syndrome, diabetes mellitus with autonomic neuropathy
2. Patients affected with peripheral vascular disease like Raynaud’s syndrome
3. Critically ill or haemodynamically unstable patients who may require massive rapid intravenous fluid resuscitation
4. Febrile patients |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Nasopharyngeal temperature |
every 15 min starting from induction of anesthesia till the end of surgery. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| axillary temperature |
once in every 15 min after start of anesthesia till end of surgery |
| Comfort level of patient during prewarming |
one point measurement after 1 hour of prewarming but just before induction of anesthesia |
| Shivering during first postoperative hour |
one point assessment after 1 hour of surgery |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
25/11/2016 |
| 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 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)?
|
|
Brief Summary
|
In this open label study two techniques of patient warming ( prewarming - convective warming beginning 1 hour before induction of anesthesia and extending into intraoperative period; cowarming - convective warming beginning with induction of anesthesia and extending into intraoperative period) will be compared to prevent intraoperative hypothermia. Included patients (approximately 60 in number) will undergo matched randomization (matched with respect to the type of surgery) to group prewarming where patients are warmed with convective warmer 1 hour prior to anesthesia and group cowarming where the convective warming begins along with the induction of general anesthesia. In both the groups warming continues into the intraoperative period till the end of the surgery. The primary outcome measure is the nasopharyngeal body temperature measured starting from induction of anesthesia, every 15 min till the end of the surgery. The secondary outcome measures are the axillary temperature measured starting from induction of anesthesia every 15 min till the end of surgery, patient comfort during prewarming in group prewarming, incidence of shivering during the first postoperative hour. |