| CTRI Number |
CTRI/2020/10/028667 [Registered on: 27/10/2020] Trial Registered Prospectively |
| Last Modified On: |
14/10/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
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Public Title of Study
|
Comparing ease of passing the tube into windpipe in patients using 3 different ways under full anaesthesia with collar around neck for stability. |
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Scientific Title of Study
|
Comparison of MILLER, McCOY, MACINTOSH Adult Laryngoscopes for Oro tracheal intubation in patients with simulated restricted neck mobility- randomised control trial |
| Trial Acronym |
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Secondary IDs if Any
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| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anusha S Kalsad |
| Designation |
Post Graduate |
| Affiliation |
Mahatama Gandhi Medical College and Research Institute, Sri Balaji Vidyapeeth university. |
| Address |
Department of Anaesthesiology second floor hospital block Mahatma gandhi medical college and research institute SBV University pillayarkuppam
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9535757961 |
| Fax |
04132615457 |
| Email |
kalsadanusha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gayatri Mishra |
| Designation |
Associate professor |
| Affiliation |
Mahatama Gandhi Medical College and Research Institute, Sri Balaji Vidyapeeth university. |
| Address |
Department of anaesthesiology second floor hospital block mahatma gandhi medical college and research institute SBV university pillaiyarkuppam
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9894354068 |
| Fax |
04132615457 |
| Email |
drgayatrimishra@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gayatri Mishra |
| Designation |
Associate professor |
| Affiliation |
Mahatama Gandhi Medical College and Research Institute, Sri Balaji Vidyapeeth university. |
| Address |
Department of anaesthesiology second floor hospital block mahatma gandhi medical college and research institute SBV university pillayarkuppam
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9894354068 |
| Fax |
04132615457 |
| Email |
drgayatrimishra@gmail.com |
|
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Source of Monetary or Material Support
|
| Department of Anaesthesiology
Mahatma Gandhi Medical College and Research Institute |
|
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Primary Sponsor
|
| Name |
Department of Anaesthesiology |
| Address |
Second floor hospital block mahatma gandhi medical college and research institute pillaiyarkuppam |
| Type of Sponsor |
Private 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 Gayatri Mishra |
Mahatma gandhi medical college and research institute |
Department of Anaesthesiolog,
Pillaiyarkuppam,
Pondicherry
607402
Pondicherry
PONDICHERRY |
989454068
04132615457
drgayatrimishra@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institution Human Ethics Committee, Mahatma Gandhi Medical College |
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: O||Medical and Surgical, |
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Intubation by Miller adult laryngoscope with simulated restricted neck mobility.
|
Miller adult laryngoscope will be compared with McCOY and Macintosh adult laryngoscopes for oro tracheal intubation under General Anaesthesia in patients with simulated restricted neck using soft cervical collar. If 1st attempt fails, second operator will intubate. If 2nd attempt fails its considered as failure and cervical collar will be removed and intubated with conventional laryngoscope with maximum allowable time of 90 seconds and Oxygen saturation fall not below 95%. |
| Comparator Agent |
Comparing Miller with McCOY and Macintosh adult laryngoscopes in patients with simulated restricted neck mobility. |
Miller adult laryngoscope will be compared with McCOY and Macintosh adult laryngoscopes for oro tracheal intubation under General Anaesthesia in patients with simulated restricted neck using soft cervical collar. If 1st attempt fails, second operator will intubate. If 2nd attempt fails its considered as failure and cervical collar will be removed and intubated with conventional laryngoscope with maximum allowable time of 90 seconds and Oxygen saturation fall not below 95%. |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Adults 18-60 Years
2. ASA I-II
3. Elective surgeries requiring General Anesthesia with Endotracheal Intubation. |
|
| ExclusionCriteria |
| Details |
1. Emergency cases.
2. Patients with cervical spine injury and pathology.
3. Anticipated difficult airway.
4. Patients with increased risk of pulmonary aspiration.
5. History of difficult intubation.
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Method of Generating Random Sequence
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Permuted block randomization, fixed |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
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Blinding/Masking
|
Not Applicable |
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Primary Outcome
|
| Outcome |
TimePoints |
Comapare IDS score (Intubation Difficulty Scale in all the three different laryngoscopes.
Namely :
1. Number of attempts.
2. Number of operators.
3. Number of alternative technique.
4. Cormack Lehane grading.
5. Lifting force required.
6. Laryngeal pressuure.
7. Vocal cord mobility. |
during intubation |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
1. Intubation time.
2. Use of bougie.
3. Hemodynamics.
4. Post operative sore throat. |
Haemodynamics at baseline, during induction and after laryngoscopy.
Haemodynamics post intubation at the intervals of 1st,2nd,3rd,4th,5th minute.
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Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/11/2020 |
| 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" |
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Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
|
Nil |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
|
Tracheal intubation should be done with utmost precaution in cervical spine injury patients as it possess great challenge to anaesthesiologist for securing airway. Neck restriction is highly essential to prevent neurological damage, failing can lead to morbidity and mortality. Studies have been done using various airway gadgets in simulated restricted neck for tracheal intubation. There is lack in literature review on Adult Miller laryngoscope for intubation in such patients. Hence we would like to compare the performance of Miller with McCoy and Macintosh adult laryngoscoes for Oro tracheal intubation using soft cervical collar, creating a simulated restricted neckmobility. Patients randomly assigned to three groups with 30 patients in each based on the device used for laryngoscopy. In Group 1 - Miller laryngoscope blade, Group 2 - McCoy laryngoscope blade and Group 3 - Macintosh laryngoscope blade. The endotracheal cuffed tube of established appropriate size will be advanced into the trachea under direct vision with or without bougie. Finally, the scope will be removed and circuit will be connected. The adequacy of ventilation will be confirmed by Capnography and Chest auscultation. If first attempts fail second operator will intervene. If second attempt fails, it will be considered as failure and the cervical collar will be removed and intubation will be done with conventional laryngoscope. First attempt success rate is defined as single passage of endotracheal tube with or without bougie. All intubations will be performed and risk management will be taken care by 5 year experienced anesthesiologist . All parameters will be recorded as per the protocol.
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