CTRI Number |
CTRI/2020/05/024961 [Registered on: 01/05/2020] Trial Registered Prospectively |
Last Modified On: |
30/04/2020 |
Post Graduate Thesis |
Yes |
Type of Trial |
Observational |
Type of Study
|
Longitudinal Crossover Study |
Study Design |
Other |
Public Title of Study
|
A study to compare two laryngoscopes, Macintosh and Airtraq to evaluate the movements of cervical spine while intubating. |
Scientific Title of Study
|
A comparative study to evaluate the cervical spine movements during laryngoscopy using Macintosh and Airtraq laryngoscopes |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Kiranpreet Kaur |
Designation |
Associate Professor |
Affiliation |
Pt.B.D.Sharma PGIMS, Rohtak |
Address |
Department of Anaesthesiology and critical care,
Pt. B.D. Sharma PGIMS,
Rohtak.
Rohtak HARYANA 124001 India |
Phone |
9992249436 |
Fax |
|
Email |
kiranpreet72@rediffmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Rameez Raja |
Designation |
Junior resident |
Affiliation |
Pt. B.D. Sharma PGIMS |
Address |
Doctors Hostel,
Department of Anaesthesiology and critical care,
Pt. B.D. Sharma PGIMS,
Rohtak.
Rohtak HARYANA 124001 India |
Phone |
9597173094 |
Fax |
|
Email |
rameezonline@live.com |
|
Details of Contact Person Public Query
|
Name |
Dr Rameez Raja |
Designation |
Junior resident |
Affiliation |
Pt. B.D. Sharma PGIMS |
Address |
Doctors Hostel,
Department of Anaesthesiology and critical care,
Pt. B.D. Sharma PGIMS,
Rohtak.
Rohtak HARYANA 124001 India |
Phone |
9597173094 |
Fax |
|
Email |
rameezonline@live.com |
|
Source of Monetary or Material Support
|
Department of Anaesthesiology and critical care
Pt. B.D. Sharma PGIMS,
Rohtak.
Haryana 124001
|
|
Primary Sponsor
|
Name |
Department of Anaesthesiology and critical care |
Address |
Pt. B.D. Sharma PGIMS,
Rohtak.
Haryana 124001 |
Type of Sponsor |
Government medical college |
|
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 Kiranpreet Kaur |
Pt. B.D. Sharma PGIMS, Rohtak |
Department of Anaesthesiology and critical care,
Pt. B.D. Sharma PGIMS, Rohtak
Haryana 124001 Rohtak HARYANA |
9992249436
kiranpreet72@rediffmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethics Commitee, Pt. B.D. Sharma PGIMS, Rohtak |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
AirTraq laryngoscope |
Patient will be ventilated again with 100 % oxygen using bag and mask for another 4-5 breaths. Second laryngoscopy using Airtraq laryngoscope will be done and third image of lateral cervical spine radiograph will be taken. Radiograph during both the laryngoscopies will be taken only after obtaining best laryngoscopic view and the laryngeal view will be graded based on modified Cormack and Lehane criteria and laryngoscopy time will be noted. |
Comparator Agent |
Macintosh laryngoscope |
Intravenous line will be secured with appropriate sized intravenous cannula. Induction of anaesthesia will be done with injection thiopentone 5 mgkg-1, fentanyl 2 µgkg-1 and vecuronium bromide 0.1 mgkg-1 intravenously. Intermittent positive pressure ventilation will be done for 3 minutes. Laryngoscopy will be first performed using Macintosh laryngoscope and second X-Ray image of lateral cervical spine will be taken and the laryngeal view will be graded based on modified Cormack and Lehane criteria and laryngoscopy time will be noted. |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
Adult patients aged between 18-60 years of either sex, belonging to American Society of Anesthesiologists (ASA) physical status I or II scheduled for elective surgery under image control requiring general anaesthesia and intubation will be enrolled in the study. |
|
ExclusionCriteria |
Details |
Patients having cervical spine injury, Rheumatoid Arthritis, Scoliosis/ spinal deformity, anticipated difficult intubation, aspiration risk, pregnancy, BMI > 30kgm-2 will be excluded from the study |
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
1.Analysis of radioimages: Atlanto occipital distance, difference between the angles made by the cervical spine, Anterior deviation of the spine, Soft tissue displacement will be measured.
The following will be assessed for both Macintosh and Airtraq laryngoscopes.Data will be compiled and appropriate statistical test will be used to analyze the results.
|
The outcome will be assessed on Day 1 of the study. It takes 30 mins to record the data and 1 week to analyze the data. |
|
Secondary Outcome
|
Outcome |
TimePoints |
1.Laryngocopic time
2. Cormack Lehanne grading
3. Hemodynmic parameters
The following will be assessed for both Macintosh and Airtraq laryngoscopes.Data will be compiled and appropriate statistical test will be used to analyze the results. |
The outcome will be assessed on Day 1 of the study. It takes 30 mins to record the data and 1 week to analyze the data. |
|
Target Sample Size
|
Total Sample Size="25" Sample Size from India="25"
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)
|
03/05/2020 |
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="0" Months="2" 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
|
The present
prospective study will be conducted in Department of Anaesthesiology & Critical care,
Pt. B.D. Sharma, PGIMS, Rohtak. A total of 25 patients, between age group of
18-60 years belonging to ASA grade I and II, scheduled
for elective surgery under image control requiring general anaesthesia and
intubation, will be enrolled in the study. Patients with cervical spine
injury, Rheumatoid
Arthritis, Scoliosis/
spinal deformity, anticipated
difficult intubation, aspiration
risk, pregnancy, BMI
> 30kg/m2 will be excluded from the study. On arrival
in the operation theatre baseline readings of electrocardiography (ECG), pulse
oximetry (SPO2)), non-invasive blood pressure (NIBP) will be recorded. Baseline image of lateral view of cervical spine
including first 4 cervical vertebrae will be taken. First laryngoscopy was
performed using Macintosh laryngoscope and second X-Ray image of lateral
cervical spine was taken. Second laryngoscopy was done using Airtraq
laryngoscope and third image of cervical spine radiograph will be taken.
Simultaneously the laryngeal view based on modified Cormack and Lehane criteria
and laryngoscopy time will be noted using both the laryngoscopes. All the three radiographs were analysed and angle
measurements from C0-C4 will be done to evaluate the cervical spine movement. In
addition, Atlanto-occipital
distance, anterior deviation of spine and soft tissue displacement during
laryngoscopy, was also calculated from radiographs. MAP, HR and
SpO2 will be recorded before induction and immediately after both
laryngoscopies. |