CTRI Number |
CTRI/2018/05/013870 [Registered on: 14/05/2018] Trial Registered Retrospectively |
Last Modified On: |
06/05/2018 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Surgical/Anesthesia |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
Methods of securing a definitive airway in Cervical spine injured patients |
Scientific Title of Study
|
Comparative evaluation of tracheal intubation using airtraq and intubating laryngeal mask airway with cervical spine immobilisation |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Sivaraj |
Designation |
Resident |
Affiliation |
Maulana Azad Medical College and Lok Nayak Hospital |
Address |
Maulana Azad Medical College
Department of Anaesthesiology and Intensive Care
Bahadur Shah Zafar Marg New Delhi Bahadur shah zafar marg new delhi 110002 Central DELHI 110002 India |
Phone |
9717864257 |
Fax |
|
Email |
sushilkumardtu@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Sonia Wadhawan |
Designation |
resident |
Affiliation |
Maulana Azad Medical College and Associated Lok Nayak Hospital |
Address |
Maulana Azad Medical College and Associated Lok Nayak Hospital
Department of Anaesthesiology
Blt block 3rd floor
Bahadur Shah Zafar Marg New Delhi Bahadur shah zafar marg new delhi 110002 Central DELHI 110002 India |
Phone |
9810946845 |
Fax |
|
Email |
soniawadhawan@hotmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Sivaraj |
Designation |
Resident |
Affiliation |
Maulana Azad Medical College and Lok Nayak Hospital |
Address |
Maulana Azad Medical College and Associated Lok Nayak Hospital
Department of Anaesthesiology
Bahadur Shah Zafar Marg New Delhi Bahadur shah zafar marg new delhi 110002 Central DELHI 110001 India |
Phone |
9717864257 |
Fax |
|
Email |
sushilkumardtu@gmail.com |
|
Source of Monetary or Material Support
|
Maulana Azad Medical College and Associated Lok Nayak Hospital
Department of Anaesthesiology
Bahadur Shah Zafar Marg New Delhi |
|
Primary Sponsor
|
Name |
Maulana Azad Medical College and Associated Lok Nayak Hospital |
Address |
Maulana Azad Medical College and Associated Lok Nayak Hospital
Department of Anaesthesiology
Bahadur Shah Zafar Marg New Delhi |
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 DEEPAK KUMAR |
Maulana Azad Medical College and Associated Lok Nayak Hospital |
Department of Anaesthesiology
Surgery, Ortho, ENT , Gynaecology operation theatre Central DELHI |
9717864257
deepakkumar3090@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
maulana azad medical college |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
patients admitted for elective surgeries, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Airtraq |
Airtraq is an optical laryngoscope designed to facilitate intubation |
Comparator Agent |
Intubating Laryngeal Mask Airway |
It is an advanced type of LMA airway device is an anatomically curved, short, wide tube attached to mask and guiding handle, designed to facilitate tracheal intubation with an endotracheal tube |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
1. ASA I and II
2. Age between 18 and 60 years
3. Undergoing elective surgery
4. Modified Mallampati grade I and II
5. BMI<30
|
|
ExclusionCriteria |
Details |
1. Patients with cervical spine or oral pathology
2. Airway distortion(post burn contracture)
3. Mouth opening less than 3cm
4. Pregnant Patients
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
An Open list of random numbers |
Blinding/Masking
|
Participant and Investigator Blinded |
Primary Outcome
|
Outcome |
TimePoints |
Time taken for intubation was defined as time taken from holding airway device for insertion to the first square shaped capnograph |
Time taken for intubation was defined as time taken from holding airway device for insertion to the first square shaped capnograph |
|
Secondary Outcome
|
Outcome |
TimePoints |
Number of attempts taken
Ease of intubation with the device (Airtraq/ILMA) as graded by Likert scale.
Hemodynamic variables(HR,MAP)
Complications if any (trauma to oropharyngeal structures, blood stains on device/ETT) |
1) . In the ILMA group it was seen that the airway device was inserted in first attempt in 88% of patients while in rest of the patients (12%), a second attempt was needed. In the Airtraq group, airway of all patients (100%) was successfully secured in the first attempt
2) Likert scale of 3 was for the ILMA group while 4 was given for Airtraq group by the operator
3) Blood stain on removal of the ILMA device was seen in 2 patients as compared to none seen in the Airtraq group. |
|
Target Sample Size
|
Total Sample Size="100" Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" |
Phase of Trial
|
Phase 3 |
Date of First Enrollment (India)
|
05/01/2017 |
Date of Study Completion (India) |
15/02/2018 |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
|
Years="1" Months="1" Days="10" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Completed |
Publication Details
|
none yet |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
In our study we endeavoured to compare Airtraq with ILMA for tracheal
intubation in simulated cervical spine injury patients with cervical spine
immobilisation using MILS. Following Institutional Review Board approval and
written informed consent, 100 adult patients between 18 to 60 years of age
scheduled for elective surgery under general anesthesia were randomly allocated
to one of the two groups (Airtraq group or ILMA group), 50 in each group. Patients
with cervical spine or any oral pathology, airway distortion, mouth opening
less than 3cm, pregnant patients were excluded from tthe study.Standard anaesthesia technique was followed for
all the patients. Inj. fentanyl 2 µg/kg IV was given. After 2mins,
anaesthesia was induced with
Inj.propofol 2 mg/kg IV. Adequacy of ventilation was assessed and muscle
relaxation was achieved with Inj. vecuronium bromide 0.1mg/Kg IV. Patient was
ventilated with 100% O2 and isoflurane≤1% for 3 mins. Subsequently the pre-checked and
prepared airway device (Airtraq or ILMA) of appropriate size was inserted
according to the standard technique after applying MILS. Hemodynamic parameters (HR,
NIBP) was recorded just before device insertion
and then every minute till 10 mins after intubation.
The Primary outcome variable was time taken for
intubation and it was taken from holding the airway device for insertion to the
first square shaped capnograph (T1+T2). The number of attempts for insertion of
airway device were noted. Pulse rate and mean arterial pressure were recorded
after insertion of airway device in both the groups every minute for the first
ten minutes. Complication like trauma to lip/tongue/oral mucosa and presence of
blood on device after removal were noted. Statistical analysis of the data was
done using the SSPS software version 22.0. P<0.05 was considered
statistically significant. There
were no statistically significant differences in demographic characteristics
between the groups. The mean time taken for the insertion of the airway device
in the ILMA group was 1.43 ± 0.61 mins and in the Airtraq group was 0.21 ± 0.11
mins. The difference is statistically significant. Even though the time taken
for intubation in the ILMA group is significantly longer than the Airtraq
group, the uninterrupted ventilation maintained during intubation in the ILMA
group ensured adequate oxygenation. In the ILMA group it was seen that airway
device was inserted in first attempt in 88% patients and a second attempt was
needed in the remaining 12%. In the Airtraq group, airway of all patients
(100%) was successfully secured in first attempt and this difference was found
to be statistically significant (p=0.027). The intubator found intubation
using Airtraq easier than intubating with ILMA as graded by the Likert scale (
4 vs 3 in Airtraq group vs ILMA group). In the hemodynamic parameters, we found that baseline
values for both heart rate and MAP in both the groups were similar without any
significant difference. However, when the heart rate was compared at different
time frames from the insertion of the airway devices i.e. at 2, 3, 4, 5, 6, 7,
8, 9, and 10 minutes of insertion it was found that the mean difference between
both the groups was statistically significant. It was observed that the heart
rate in Airtraq group is more controlled and stable as compared to the ILMA
group. We observed that there was immediate rise in MAP (at 1, 2 and 3 mins) in
both the groups after insertion of the airway device which was more in the ILMA
group as compared to the Airtraq group, though this difference was not
statistically significant. This could have been due to the sympathetic
stimulation seen during airway manipulation.Subsequently, when the MAP was
compared at time frames of 4, 5, 6, 7, 8, 9
minutes after insertion of the airway device in both the groups, the
difference was statistically significant and
the readings were found to be more controlled in the Airtraq group as
compared to the ILMA group. Blood stain on the ILMA device after removal was
seen in 2 patients as compared to none seen in the Airtraq group. The
difference was statistically not significant.
From our study, we suggest the use of Airtraq in
difficult airway scenarios with limited/ restricted neck movements. Decreased
hemodynamic response to intubation using Airtraq makes it a promising device in
patients with CAD and hypertension. |