| CTRI Number |
CTRI/2022/01/039365 [Registered on: 12/01/2022] Trial Registered Prospectively |
| Last Modified On: |
01/09/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Positioning of patient for giving General Anaesthesia in trolley |
|
Scientific Title of Study
|
Comparison of intubating conditions in two different head elevations for direct laryngoscopy in trolley: A Prospective randomised controlled study |
| Trial Acronym |
HELDinT |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Tejasri KetiREddy |
| Designation |
Resident |
| Affiliation |
NIMS |
| Address |
Dept of Anaesthesia And Critical Care
Nizams Institute of Medical SCiences
Panjagutta
Hyderabad
Hyderabad
TELANGANA
500008
India |
| Phone |
|
| Fax |
|
| Email |
tejasri.ketireddy@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Tejasri KetiREddy |
| Designation |
Resident |
| Affiliation |
NIMS |
| Address |
Dept of Anaesthesia And Critical Care
Nizams Institute of Medical SCiences
Panjagutta
Hyderabad
Hyderabad
TELANGANA
500008
India |
| Phone |
|
| Fax |
|
| Email |
tejasri.ketireddy@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Kavitha Jayaram |
| Designation |
Associate Professor |
| Affiliation |
Associate professor |
| Address |
B 410,Western plaza
Shaikpet
Manikonda
Hyderabad
Department of anesthesiology and intensive care
NIMS
Panjagutta
Hyderabad
Hyderabad
TELANGANA
500080
India |
| Phone |
|
| Fax |
|
| Email |
drkarunya@gmail.com |
|
|
Source of Monetary or Material Support
|
| Nizams institute of medical sciences |
|
|
Primary Sponsor
|
| Name |
NIMS |
| Address |
NIMS
Panjagutta
Hyderabad |
| Type of Sponsor |
Government 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 |
| Tejasri Ketireddy |
Nizams Institute Of Medical Sciences |
Department of anesthesiology and intensive care, NIMS
Panjagutta
Hyderabad
Hyderabad
TELANGANA |
8919350754
tejasri.ketireddy@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NIMS Institutional Ethics Committee |
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 |
| Comparator Agent |
customised head cushion |
At the time of intubation only |
| Intervention |
popitz pillow |
Only at the time of intubation |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
undergoing elective surgery in prone postion under general anaesthesia |
|
| ExclusionCriteria |
| Details |
ASA >/III patients
BMI >30 kg/m2
difficult mask ventilation or intubation
emergency |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare glottis visualisation during direct laryngoscopy for intubation in trolley while using two different head supports |
During direct laryngoscopy only |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assess intubating conditions, intubation difficulty score, time taken for intubation |
At the time of intubation |
|
|
Target Sample Size
|
Total Sample Size="156"
Sample Size from India="156"
Final Enrollment numbers achieved (Total)= "156"
Final Enrollment numbers achieved (India)="156" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
28/01/2022 |
| Date of Study Completion (India) |
30/05/2022 |
| Date of First Enrollment (Global) |
28/01/2022 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Will be sent for publication once the study is complete |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Effectiveness of Sniffing position , the gold standard and ideal position for better glottic visualisation has been questioned and different head elevations have been suggested. So we designed this study in 156 patients aged 18 to 60 years of both sex undergoing elective surgery in prone position using conventional head cushion or popitz pillow intubated in trolley, after getting NIEC approval and CTRI registration . Our study participants will be divided into 2 groups : group S - Conventional head cushion , group P-popitz pillow. After induction, the patients will be positioned for direct laryngoscopy in sniffing position with either of the pillow as per the group. Preoperative airway parameters, intubation difficulty score and time taken for intubation will be measured. |