| CTRI Number |
CTRI/2020/01/022744 [Registered on: 14/01/2020] Trial Registered Prospectively |
| Last Modified On: |
02/12/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To study the effect of three head positions on ease of placing tube in wind pipe |
|
Scientific Title of Study
|
Evaluation of videolaryngoscopy guided tracheal intubation characteristics in neutral, sniffing and simple extension head position 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 |
Arushi Saili |
| Designation |
Post graduate student |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of Anaesthesia and Intensive Care, Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi 110029 New Delhi 110029
South
DELHI
110029
India |
| Phone |
26198462 |
| Fax |
|
| Email |
arushisaili@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Smita Prakash |
| Designation |
Consultant |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of Anaesthesia and Intensive Care, Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi 110029 New Delhi 110029
South
DELHI
110029
India |
| Phone |
26198462 |
| Fax |
|
| Email |
drsunilprakash@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Smita Prakash |
| Designation |
Consultant |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of Anaesthesia and Intensive Care, Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi 110029 New Delhi 110029
South
DELHI
110029
India |
| Phone |
26198462 |
| Fax |
|
| Email |
drsunilprakash@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi |
|
|
Primary Sponsor
|
| Name |
Safdarjung Hospital |
| Address |
Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi |
| 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 |
| 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 New Delhi 110029
South
DELHI |
26198462
drsunilprakash@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R098||Other specified symptoms and signsinvolving the circulatory and respiratory systems, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Neutral and simple extension head position |
Laryngoscopy and tracheal intubation characteristics with head in neutral and simple extension head position |
| Comparator Agent |
Sniffing head position |
Laryngoscopy and tracheal intubation characteristics will be noted with head in sniffing position |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients belonging to American Society of Anesthesiologists physical status I and II, scheduled for elective surgery under general anesthesia with tracheal intubation |
|
| ExclusionCriteria |
| Details |
1.Patients with predicted difficult airway requiring awake tracheal intubation
2.Obvious malformation of the neck or face, known oropharyngeal pathology, unstable cervical spine
3.Patients requiring rapid sequence intubation
4.Pregnancy
5. BMI > 30 kg/m2
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the neutral, sniffing and simple extension head position for ease of videolaryngoscopy-guided tracheal intubation using Modified Intubation Difficulty Score in adult patients undergoing elective surgery under general anaesthesia |
At the time of videolaryngoscopy and tracheal intubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Intubation time
2. Laryngoscopic view assessed by Cormack and Lehane grading and by Percentage of Glottic Opening (POGO) score
3. First attempt success rate
|
At the time of videolaryngoscopy and tracheal intubation |
|
|
Target Sample Size
|
Total Sample Size="180"
Sample Size from India="180"
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)
|
20/01/2020 |
| 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
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Successful placement of the tracheal tube during
videolaryngoscopy may depend on head and neck position. A
suboptimal head and neck position may be associated with difficult
videolaryngoscopy and tracheal intubation and repeated attempts at laryngoscopy
that can lead to poor outcomes. Videolaryngoscopy involves visualising the vocal cords by means other
than direct sight. The sniffing position may not be advantageous during performance of
videolaryngoscopy as it is not necessary to align the three axes to obtain
glottis view. Impingement of the tracheal tube on the anterior
tracheal wall is one of the factors associated with technical difficulties
during videolaryngoscopy-guided intubation.
It has been suggested that impingement of the tracheal
tube on the anterior tracheal wall is more likely to occur in the sniffing
position due to lower cervical spine flexion compared with the neutral or
simple extension position. No significant difference in the ease of intubation was found between the
sniffing and the neutral position when using C-MAC®
videolarygoscope. Head and
neck position in supine sniffing position was found to be a predictor of
difficult videolaryngoscopy compared with supine neutral position.
There is paucity of literature
investigating the optimal head and neck position for videolaryngoscopy. The study hypothesis is that the neutral
position would be superior to the sniffing position and the simple extension
position with regard to ease of intubation while performing C-MAC® videolaryngoscopy in adult patients undergoing
surgery under general anaesthesia. The aim of this prospective, randomised
study is to determine the differences between the sniffing, neutral and simple
neck extension position with regard to ease of intubation as determined by the
modified intubation difficulty scale by videolaryngoscopy in adult patients undergoing
elective surgery under general anaesthesia with tracheal intubation. Intubation time, Percentage of glottic opening score, Cormack-Lehane laryngoscopy grade and first attempt success rate will also be compared. |