| CTRI Number |
CTRI/2024/06/068659 [Registered on: 11/06/2024] Trial Registered Prospectively |
| Last Modified On: |
07/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of Airway management using AIROD and Gum elastic Bougie. |
|
Scientific Title of Study
|
A Comparative evaluation of AIROD vs Gum elastic Bougie as an intubation adjunct in simulated difficult airway.
|
| Trial Acronym |
NIL |
|
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 |
Professor |
| Affiliation |
Pt. BD Sharma PGIMS Rohtak |
| Address |
Department of Anaesthesiology & Critical care, Pt. BD Sharma PGIMS, Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
9992249436 |
| Fax |
|
| Email |
kiranpreet72@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vikash |
| Designation |
Junior Resident |
| Affiliation |
Pt. BD Sharma PGIMS Rohtak |
| Address |
Department of Anaesthesiology & Critical care, Pt. BD Sharma PGIMS, Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
9467002626 |
| Fax |
|
| Email |
panwarvikash93@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vikash |
| Designation |
Junior Resident |
| Affiliation |
Pt. BD Sharma PGIMS Rohtak |
| Address |
Department of Anaesthesiology & Critical care, Pt. BD Sharma PGIMS, Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
9467002626 |
| Fax |
|
| Email |
panwarvikash93@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institutional, Pt. B.D. Sharma PGIMS Rohtak PIN CODE 124001 HARYANA INDIA |
|
|
Primary Sponsor
|
| Name |
Pt BD Sharma University of Health Sciences PGIMS Rohtak Haryana |
| Address |
Pt. B.D. Sharma University of Health Sciences PGIMS, ROHTAK PIN CODE 124001 HARYANA INDIA |
| 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 Vikash |
Pt. B.D. Sharma PGIMS |
Department of Anaesthesiology & Critical care Rohtak
Rohtak
HARYANA |
9467002626
Panwarvikash93@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Pt BD Sharma PGIMS Rohtak |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: X||New Technology, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
AIROD |
Standardized anaesthesia protocol will be followed. The cervical collar will be placed around the neck to create a simulated difficult airway. Pre-oxygenation for 3 minutes will be done with 100% O2. Induction of anaesthesia will be done with glycopyrrolate (0.005mgkg-1), fentanyl (2µkg-1) and propofol (2mgkg-1). After successful mask ventilation, injection vecuronium (0.1mgkg-1) will be given to achieve adequate neuromuscular block. Patient will be ventilated for 3 minutes via facemask and anaesthesia breathing system with 100% oxygen and 2% sevoflurane.Fully extended & locked AIROD will be lubricated and preloaded with the lubricated ETT of size 7.0 mm ID in females and 8.0 mm ID in males. The Macintosh laryngoscope blade will be inserted into the patient’s oral cavity, and the tongue will be displaced to the left side. Cormack- Lehane grading will be noted. After glottic visualization, intubating device will be inserted in the oropharynx. In patients intubated with AIROD proximal tip will be used to lift the epiglottis. The distal tip of introducer will be negotiated towards the trachea. It will be negotiated till 2 cm past the vocal cords. An assistant will be instructed to slide the ETT down the device. Once the intubation mark crosses the glottis, the introducer and laryngoscope will be withdrawn. Thereafter ETT will be connected to the anesthesia circuit and anesthesia will be maintained using sevoflurane in N2O and oxygen mixture. The number of redirection attempts of the device towards the glottis, total time for successful intubation, ease of intubation, maneuvers required (If external laryngeal manipulation is required then the front of the cervical collar will be removed), airway trauma and hemodynamic changes will be recorded. |
| Comparator Agent |
Gum elastic Bougie |
Standardized anaesthesia protocol will be followed. The cervical collar will be placed around the neck to create a simulated difficult airway. Pre-oxygenation for 3 minutes will be done with 100% O2. Induction of anaesthesia will be done with glycopyrrolate (0.005mgkg-1), fentanyl (2µkg-1) and propofol (2mgkg-1). After successful mask ventilation, injection vecuronium (0.1mgkg-1) will be given to achieve adequate neuromuscular block. Patient will be ventilated for 3 minutes via facemask and anaesthesia breathing system with 100% oxygen and 2% sevoflurane.Fully extended & locked Bougie will be lubricated and preloaded with the lubricated ETT of size 7.0 mm ID in females and 8.0 mm ID in males. The Macintosh laryngoscope blade will be inserted into the patient’s oral cavity, and the tongue will be displaced to the left side. Cormack- Lehane grading will be noted. After glottic visualization, intubating device will be inserted in the oropharynx.The distal tip of introducer will be negotiated towards the trachea. It will be negotiated till 2 cm past the vocal cords. An assistant will be instructed to slide the ETT down the device. Once the intubation mark crosses the glottis, the introducer and laryngoscope will be withdrawn. Thereafter ETT will be connected to the anesthesia circuit and anesthesia will be maintained using sevoflurane in N2O and oxygen mixture. The number of redirection attempts of the device towards the glottis, total time for successful intubation, ease of intubation, maneuvers required (If external laryngeal manipulation is required then the front of the cervical collar will be removed), airway trauma and hemodynamic changes will be recorded. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Seventy patients of either sex aged 18-60 years belonging to American Society of Anaesthesiologists (ASA) physical status I or II scheduled for elective surgery under general anaesthesia requiring endotracheal intubation will be included in the study. |
|
| ExclusionCriteria |
| Details |
Patients having respiratory or pharyngeal pathology,restricted mouth opening,Body mass index more than 30,pregnancy,full stomach,anticipated difficult airway and any patient who refuses to participate in the study 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 |
| To compare the first pass success rate of intubation through AIROD and gum elastic bougie. |
Baseline MAP, HR and SPO2 will be recorded. Thereafter values will be recorded after induction, and at 1st, 3rd and 5th minute after successful intubation. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Number of attempts taken to insert the introducer,Ease of passing the introducer
,Total time taken for successful intubation,Ease of intubation
,Optimisation manoeuvres required for intubation
,Haemodynamic variation
,Complications secondary to device placement.
|
Baseline MAP, HR and SPO2 will be recorded. Thereafter values will be recorded after induction, and at 1st, 3rd and 5th minute after successful intubation. |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/07/2024 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
AIROD and Gum elastic bougie both are helpful in managing difficult airway with different structural features. AIROD have an additional advantage of displacing the oropharyngeal tissue, lifting the epiglottis, and unique locking mechanism making it more suitable device for intubation. Hence the purpose of study is to compare AIROD and Bougie as an intubation adjunct to endotracheal intubation in adult patients planned for surgery under general anaesthesia. |