| CTRI Number |
CTRI/2019/06/019782 [Registered on: 20/06/2019] Trial Registered Prospectively |
| Last Modified On: |
23/10/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to compare two airway devices in patients with fixed neck. |
|
Scientific Title of Study
|
A study to compare Air Q with Intubating Laryngeal Mask Airway as intubation conduit in patients with simulated fixed cervical spine |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Renu Bala |
| Designation |
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
Rohtak
HARYANA
124001
India |
| Phone |
8901322251 |
| Fax |
|
| Email |
neurodmrenu@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jasmine Basumatary |
| Designation |
Postgraduate student |
| Affiliation |
Pt. B. D. Sharma , PGIMS , Rohtak |
| Address |
Department of Anaesthesiology and Critical Care , Pt. B. D. Sharma , PGIMS, Rohtak.
HARYANA
124001
India
Rohtak
HARYANA
124001
India |
| Phone |
7896567209 |
| Fax |
|
| Email |
j.basumatary50@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jasmine Basumatary |
| Designation |
Postgraduate student |
| Affiliation |
Pt. B. D. Sharma , PGIMS , Rohtak |
| Address |
Department of Anaesthesiology and Critical Care , Pt. B. D. Sharma , PGIMS, Rohtak.
HARYANA
124001
India
Rohtak
HARYANA
124001
India |
| Phone |
7896567209 |
| Fax |
|
| Email |
j.basumatary50@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institutional , Pt. B. D. Sharma , PGIMS , ROHTAK, HARYANA |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesiology and Critical Care |
| Address |
Pt. B. D. Sharma PGIMS, Rohtak
Haryana, 124001. |
| Type of Sponsor |
Government medical college |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Jasmine |
Pt. B. D. Sharma, PGIMS , ROHTAK |
Department of anaesthesia and Critical Care , Pt. B.D. Sharma PGIMS Rohtak , Haryana. 124001
Rohtak
HARYANA |
7896567209
j.basumatary50@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K800||Calculus of gallbladder with acutecholecystitis, (2) ICD-10 Condition: K403||Unilateral inguinal hernia, with obstruction, without gangrene, (3) ICD-10 Condition: K36||Other appendicitis, (4) ICD-10 Condition: K605||Anorectal fistula, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Air Q Intubating Laryngeal Airway |
A two piece semi rigid cervical collar of appropriate size will be placed around the neck of the patient . All the routine vital monitors will be attached and intravenous access will be obtained. Preoxygenation will be done with 100% oxygen for 3mins. Induction will be done with inj. Glycopyrrolate 0.2mg, inj. Fentanyl 2mcg per kg , inj. Propofol 2-2.5mg per kg . After loss of eye lash reflex , bag mask ventilation will be confirmed and inj. Vecuronium 0.12mg per kg will be administered. Manual inline stabilisation will established and the front part of the cervical collar will be removed . Depending on the randomisation number intubation will be carried out by either of the two supraglottic devices Air Q and Intubating Laryngeal Mask Airway . |
| Comparator Agent |
Intubating Laryngeal Mask Airway |
Successful placement of the device will be confirmed . Ventilation through the device will be checked by putting the patient on volume control mode of ventilation. Fiberoptic grading will be done for laryngeal view of the vocal cord. Intubation will be attempted using Parker Flex Tip Endotracheal tube. Maximum of three attempts will be done . Two attempts for blind intubation and third one fiberoptic guided. If all three attempts fail. Intubation will be done using conventional direct laryngoscopy following release of MILS. Rest of anaesthesia will be administered as per standard protocol. The following observations will be made- success rate of intubation, number of attempts, time taken for insertion of device and intubation, ventilation through device, fiberoptic grading, haemodynamic parameters, adverse effects . |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Adult patient 18 to 60 years of age of either sex , ASA physical status I or II , scheduled for elective surgery under general anaesthesia requiring intubation . |
|
| ExclusionCriteria |
| Details |
Patients at risk of gastric content aspiration , anticipated difficult airway, interincisor gap <2.5cm , BMI >30, poor lung compliance and abnormal oropharyngeal anatomy . |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Success rate of intubation.
2. Number of attempts.
3. Time taken for insertion of device and intubation.
4. Ventilation through device.
5. Fibre optic grading .
6. Haemodynamic parameters.
7. Adverse effects . |
The following will be assessed for both Air Q and Intubating Laryngeal Mask Airway . Data will be compiled and appropriate statistical test will be used to analyse the results
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Success rate of intubation.
2. Number of attempts.
3. Time taken for insertion of device and intubation.
4. Ventilation through device.
5. Fibre optic grading .
6. Haemodynamic parameters.
7. Adverse effects . |
The following will be assessed for both Air Q and Intubating Laryngeal Mask Airway. Data will be compiled and appropriate statistical test will be used to analyse the results
|
|
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Target Sample Size
|
Total Sample Size="88"
Sample Size from India="88"
Final Enrollment numbers achieved (Total)= "90"
Final Enrollment numbers achieved (India)="90" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
24/06/2019 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
03/03/2020 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The aim and objectives of the thesis is to evaluate and compare endotracheal intubation through two supraglottic airway devices, Air Q Intubating Laryngeal Airway and Intubating Laryngeal Mask Airway as intubation conduit in patients with simulated fixed cervical spine. Adult patient, 18 to 60 years of age of either sex, ASA physical status I and II, scheduled for elective surgery under general anaesthesia requiring intubation. Total of 88 patients, 44 in each group will be studied. The success rate of intubation in both the groups, time taken for intubation, number of attempts, fiberoptic grading, haemodynamic changes and complications if any will be assessed. Data will be compiled and appropriate statistical test will be done to analyse the result. |