| CTRI Number |
CTRI/2014/11/005168 [Registered on: 05/11/2014] Trial Registered Prospectively |
| Last Modified On: |
03/11/2014 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Compare The Ease of placement of airway conduit In two different head positions in patients posted for surgeries under general anesthesia. |
|
Scientific Title of Study
|
Comparison Of Ease Of Intubation In Sniffing Position And Further Neck Flexion |
| Trial Acronym |
CEI |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr G Kiran Kumar |
| Designation |
RESIDENT |
| Affiliation |
Nizams Institute Of Medical Sciences(NIMS) |
| Address |
Department of Anaesthesiology & Intensive Care
NIMS,
Panjagutta, Hyderabad.
TELANGANA
Hyderabad
ANDHRA PRADESH
500082
India |
| Phone |
9490887406 |
| Fax |
|
| Email |
gkiran17medico@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nirmala J |
| Designation |
Additional Professor |
| Affiliation |
Nizams Institute Of Medical Sciences(NIMS) |
| Address |
Department of Anaesthesiology & Intensive Care
NIMS, Panjagutta, Hyderabad.
TELANGANA
Hyderabad
ANDHRA PRADESH
500082
India |
| Phone |
9849422749 |
| Fax |
|
| Email |
njonnavithula@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nirmala J |
| Designation |
Additional Professor |
| Affiliation |
Nizams Institute Of Medical Sciences(NIMS) |
| Address |
Department of Anaesthesiology & Intensive Care
NIMS, Panjagutta, Hyderabad.
TELANGANA
ANDHRA PRADESH
500082
India |
| Phone |
9849422749 |
| Fax |
|
| Email |
njonnavithula@gmail.com |
|
|
Source of Monetary or Material Support
|
| Nizams Institute Of Medical Sciences, Panjagutta, Hyderabad. |
|
|
Primary Sponsor
|
| Name |
Nizams Institute of Medical Sciences |
| Address |
Department of Anaesthesiology & Intensive Care
NIMS, Hyderabad. |
| 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 G Kiran Kumar |
Nizams Institute Of Medical Sciences |
Nizams Institute Of Medical Sciences, Panjagutta, Hyderabad.
Hyderabad
ANDHRA PRADESH |
9490887406
gkiran17medico@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NIMS INSTITUTIONAL ETHICS COMMITTTE (NIEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Study involves patients undergoing elective surgeries under general anesthesia(GA). Endotracheal intubation is standard for any patient receiving routine GA.Hence no additional risk to the patient., |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Endotracheal intubation will be done with patient in head elevation position |
Endotracheal intubation is the standard of care for any patient receiving routine general anesthesia. |
| Intervention |
Endotracheal intubation will be done with patient in standard intubating position (sniffing position) |
Endotracheal intubation is the standard of care for any patient receiving routine general anesthesia. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients scheduled for elective surgery requiring endotracheal intubation under general anaesthesia.
1. ASA I & II
2. [Patients of both genders between age 18 to 65]
3. Mallampati Grade I & II
4. Willing to participate in the study by giving written informed consent
|
|
| ExclusionCriteria |
| Details |
1. ASA status III and above
2. Pregnant patients
3. Patients with risk of pulmonary aspiration of gastric contents
4. Patients with gastro-esophageal reflux disease
5. Patients with reactive airway and active URI |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Primary outcome we are going to access is Intubation difficulty scoring(IDS) in two different intubating positions |
Results are immediate upon the completion of intubation. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Secondary outcome obtained by Subgroup analysis between IDS and airway parameters. |
Results of secondary outcome will be obtained after the statistical analysis. |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
15/11/2014 |
| 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="0"
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
|
It is a Randomized Cross over study
involving 100 adult patients scheduled for elective surgery requiring
endotracheal intubation under general anaesthesia. We evaluate whether further
neck flexion (head elevation) beyond standard intubating position (Sniffing
position) may improve the glottic view during intubation.
The principal investigator will
perform laryngoscopy in two different positions and access the glottic view in
both positions. The subjects may not be benefitted in the study. But it
in the long run this study will benefit the patient population as a whole and
will add to the literature in difficult airway subset of population.
|