The objective of this study is to compare the conventional measurement of neck extension versus ultrasound guided distance measured from skin to epiglottis (DSE) as sole predictors in determining difficult airway and laryngoscopy.
Design
150 patients (minimum sample size 139 as per WHO calculator) were included in the study as per the inclusion criteria furnished . The method of sampling was non-probability consecutive via lottery method.
Settings and conduct
Maximum angle for neck extension in was measured with the patient sitting while keeping the head erect with mouth wide open and then asked to extend the head maximally while the anesthetist measured the angle traversed by the occlusal surface of the upper teeth. . In Group E, linear probe using ultrasound guidance was used to measure the distance from skin to epiglottis in the sniffing position with the patient lying supine . To remove bias, the anesthetist performing pre-operative airway assessment were different to those confirming through Cormack Lehane scoring.
Participants/Inclusion and exclusion criteria
Inclusion criteria included all ASA I and II patients aged 20-40 years presenting to the anesthesia
department after pre-anesthesia assessment for subsequent elective surgeries under general
anesthesia
Exclusion criteria excluded patients with patients with a history of burns or trauma to the airways, patient with a history of tracheostomy or lower
airway surgeries and patients unwilling to be included in the study.
Intervention groups
All the patients included in the study were divided into two groups, Group N, undergoing neck extension
as sole predictor and Group E, using DSE by USG as a sole predictor for difficulty airway.
Main outcome variables
Comparison of sensitivity and specificity showed a sensitivity of 76.9% in Group N versus 88.4% in Group E (DSE). Specificity showed 69.4% in Group N versus 87.5% in Group E.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230809059095N2
Registration date:2023-09-12, 1402/06/21
Registration timing:retrospective
Last update:2023-09-12, 1402/06/21
Update count:0
Registration date
2023-09-12, 1402/06/21
Registrant information
Name
Hassan Minhas
Name of organization / entity
Combined Military Hospital, Rawalpindi, Pakistan
Country
Pakistan
Phone
+92 345 5264734
Email address
h.hassan.nasir@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-01, 1400/10/11
Expected recruitment end date
2022-06-30, 1401/04/09
Actual recruitment start date
2022-01-01, 1400/10/11
Actual recruitment end date
2022-06-30, 1401/04/09
Trial completion date
2022-06-30, 1401/04/09
Scientific title
Comparison of Neck Extension Versus Ultrasound Guided Distance Measured from Skin to Epiglottis (DSE) as Sole Predictors of Difficult Intubation
Public title
Sole Predictors of Difficult Intubation - Neck Extension Vs DSE
Purpose
Screening
Inclusion/Exclusion criteria
Inclusion criteria:
ASA I and II patients
aged 20-40 yrs
Elective Surgery
Surgery under General Anesthesia
Exclusion criteria:
History of Burns and Trauma to airway
Tracheostomy
Previous lower airway surgery
Unwilling
Age
From 20 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
139
Actual sample size reached:
150
Randomization (investigator's opinion)
Randomized
Randomization description
The method of sampling was non-probability consecutive via lottery method.
Blinding (investigator's opinion)
Double blinded
Blinding description
To remove bias, the anesthetist performing pre-operative airway assessment were different to those confirming through Cormack Lehane scoring during intubation
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Combined Military Hospital, Rawalpindi, Pakistan
Street address
CMH Road
City
Rawalpindi
Postal code
46000
Approval date
2021-12-15, 1400/09/24
Ethics committee reference number
431/12/21
Health conditions studied
1
Description of health condition studied
Screening for Difficult Intubation
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
ultrasound guided distance measured from skin to epiglottisis is superior to conventional neck extension when used as sole agents to diagnose difficult airwayin suspected patients.
Timepoint
On intubation
Method of measurement
Visibility on laryngoscopy
Secondary outcomes
empty
Intervention groups
1
Description
Comparison group 1: undergoing neck extension as sole predictor
Category
Early detection
2
Description
Comparison group 2: using DSE by USG as a sole predictor for difficulty airway
Category
Early detection
Recruitment centers
1
Recruitment center
Name of recruitment center
Combined Military Hospital
Full name of responsible person
Hassan Nasir Minhas
Street address
CMH Road
City
Rawalpindi
Postal code
46000
Phone
+92 51 9270163
Email
h.hassan.nasir@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Armed Forces Post Graduate Medical Institute
Full name of responsible person
Hassan Nasir Minhas
Street address
CMH Road
City
Rawalpindi
Postal code
46000
Phone
+92 345 5264734
Email
h.hassan.nasir@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Armed Forces Post Graduate Medical Institute
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Armed Forces Post Graduate Medical Institute
Full name of responsible person
HassanNasir Minhas
Position
Registrar
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
CMH Road
City
Rawalpindi
Province
Punjab
Postal code
46000
Phone
+92 345 5264734
Email
h.hassan.nasir@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Armed Forces Post Graduate Medical Institute
Full name of responsible person
Hassan Nasir Minhas
Position
Registrar
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
CMH Road
City
Rawalpindi
Province
Punjab
Postal code
46000
Phone
+92 345 5264734
Email
h.hassan.nasir@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Armed Forces Post Graduate Medical Institute
Full name of responsible person
Hassan Nasir Minhas
Position
Registrar
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
CMH Road
City
Rawalpindi
Province
Punjab
Postal code
46000
Phone
+92 345 5264734
Email
h.hassan.nasir@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available