CTRI Number |
CTRI/2016/09/007313 [Registered on: 27/09/2016] Trial Registered Prospectively |
Last Modified On: |
28/01/2019 |
Post Graduate Thesis |
No |
Type of Trial |
Observational |
Type of Study
|
Cohort Study |
Study Design |
Single Arm Study |
Public Title of Study
|
To study the effect of measurements of the face and neck on difficulty in seeing the larynx during anaesthesia in adults |
Scientific Title of Study
|
Evaluation of thyromental height, ratio of height to thyromental distance and thyromental distance as predictors of difficult laryngoscopy (and difficult intubation) in adult patients |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
Nil |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Smita Prakash |
Designation |
Professor |
Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi, India |
Address |
C - 17
HUDCO place Safdarjung Hospital, New Delhi 110029 South DELHI 110049 India |
Phone |
09810347125 |
Fax |
26163072 |
Email |
drsunilprakash@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Smita Prakash |
Designation |
Professor |
Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi, India |
Address |
C - 17
HUDCO place Safdarjung Hospital, New Delhi 110029 South DELHI 110049 India |
Phone |
09810347125 |
Fax |
26163072 |
Email |
drsunilprakash@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Smita Prakash |
Designation |
Professor |
Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi, India |
Address |
C - 17
HUDCO place Safdarjung Hospital, New Delhi 110029 South DELHI 110049 India |
Phone |
09810347125 |
Fax |
26163072 |
Email |
drsunilprakash@gmail.com |
|
Source of Monetary or Material Support
|
Safdarjung Hospital, New Delhi 110029 |
|
Primary Sponsor
|
Name |
Safdarjung Hospital |
Address |
Department of Anaesthesia and Intensive Care, Vardhman Mahavir Medical College, New Delhi 110029 |
Type of Sponsor |
Government medical college |
|
Details of Secondary Sponsor
|
Name |
Address |
Nil |
Not applicable |
|
Countries of Recruitment
|
India |
Sites of Study
|
No of Sites = 1 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
Dr Smita Prakash |
Safdarjung Hospital |
Main Operation Theatre, 2nd Floor, Department of Anaesthesia and Intensive Care, Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi 110029 South DELHI |
09810347125
drsunilprakash@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institute Ethics Committee, Safdarjang Hospital and VMMC, New Delhi 110029 |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
Health Type |
Condition |
Patients |
, Difficult laryngoscopy, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
Not applicable |
Not applicable |
Intervention |
Observational study |
Observational study |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
99.00 Year(s) |
Gender |
Both |
Details |
American Society of Anaesthesiologists physical status grade I or II adult patients, scheduled to undergo elective surgery under general anaesthesia with tracheal intubation. |
|
ExclusionCriteria |
Details |
1. Patients with obvious abnormality of the airway requiring awake tracheal intubation
2. Post burn contracture neck, neck swelling
3. Inter‑incisor distance <2.5 cm
4. Patients at increased risk of aspiration
5. Unstable cervical spine
|
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
Primary Outcome
|
Outcome |
TimePoints |
To determine the prediction index (cut-off value) and validity indices for thyromental height |
At time of laryngoscopy and intubation |
|
Secondary Outcome
|
Outcome |
TimePoints |
1. To determine the validity indices for ratio of height to thyromental distance and thyromental distance for prediction of difficult laryngoscopy in adult patients.
2.To compare the thyromental height, ratio of height to thyromental distance and thyromental distance as predictors of difficult laryngoscopy in adult patients
|
At time of laryngoscopy and intubation |
|
Target Sample Size
|
Total Sample Size="300" Sample Size from India="300"
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)
|
01/11/2016 |
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="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
Publication Details
|
Not applicable |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
Unexpected difficult laryngoscopy (DL) or intubation
or failed tracheal intubation is an important
aetiological factor in anaesthesia related morbidity and mortality. Several
anthropometric measurements have been proposed to identify potentially difficult
airways. Amongst these, the thyromental distance (TMD) has been widely used in
the preoperative airway evaluation. The sensitivity and specificity of TMD as a
predictor for difficult laryngoscopy is low and its role as a predictive test
is debatable. As TMD will vary with
patient size, the ratio of height to TMD (RHTMD) may have a better predictive
value than TMD alone, as the TMD cut-off value will be adjusted for patient
size.
The thyromental height (the height between the anterior borders of the
mentum and thyroid cartilage with the patient in supine position and mouth closed)
has been suggested as predictor of difficult laryngoscopy.
The study
hypothesis is that the height between the anterior borders of the mentum and
thyroid cartilage, the thyromental height, can be a predictor of difficult
laryngoscopy. The research question is to evaluate and compare the thyromental
height, ratio of height to thyromental distance and thyromental distance for
prediction of difficult laryngoscopy in adult patients undergoing
elective surgery under general anaesthesia. The primary outcome measure is
calculation of the prediction index (cut off value) and validity indices for the
thyromental height. |