| CTRI Number |
CTRI/2019/09/021054 [Registered on: 04/09/2019] Trial Registered Prospectively |
| Last Modified On: |
03/09/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Comparison of two different laryngoscopes for intubation on the same individual.
|
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Scientific Title of Study
|
Comparision of ease of oro-tracheal intubation using Adult Miller and Macintosh blade - A randomized crossover study.
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vaibhav Pandey |
| Designation |
Post Graduate, Anaesthesiology. |
| Affiliation |
Mahatama Gandhi Medical College and Research Institute, Sri Balaji Vidyapeeth university. |
| Address |
Department of Anesthesiology, A2 block, Second floor,
Mahatama Gandhi Medical College and Research Institute, Sri Balaji Vidyapeeth university, Pondicherry Cuddalore ECR, Pillayarkuppam.
Department of Anesthesiology, A2 block, Second floor,
Mahatama Gandhi Medical College and Research Institute, Sri Balaji Vidyapeeth university, Pondicherry Cuddalore ECR, Pillayarkuppam.
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9663220844 |
| Fax |
|
| Email |
vaibhavpandey2297@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Gayatri Mishra |
| Designation |
Associate Professor, Anaesthesiology. |
| Affiliation |
Mahatama Gandhi Medical College and Research Institute, Sri Balaji Vidyapeeth university. |
| Address |
Department of Anesthesiology, A2 block, Second floor,
Mahatama Gandhi Medical College and Research Institute, Sri Balaji Vidyapeeth university, Pondicherry Cuddalore ECR, Pillayarkuppam.
Department of Anesthesiology, A2 block, Second floor,
Mahatama Gandhi Medical College and Research Institute, Sri Balaji Vidyapeeth university, Pondicherry Cuddalore ECR, Pillayarkuppam.
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9894354068 |
| Fax |
|
| Email |
drgayatrimishra@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Balachandar S |
| Designation |
Assistant Professor, Anaesthesiology |
| Affiliation |
Mahatama Gandhi Medical College and Research Institute, Sri Balaji Vidyapeeth university. |
| Address |
Department of Anesthesiology, A2 block, Second floor,
Mahatama Gandhi Medical College and Research Institute, Sri Balaji Vidyapeeth university, Pondicherry Cuddalore ECR, Pillayarkuppam.
Department of Anesthesiology, A2 block, Second floor,
Mahatama Gandhi Medical College and Research Institute, Sri Balaji Vidyapeeth university, Pondicherry Cuddalore ECR, Pillayarkuppam.
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9894540176 |
| Fax |
|
| Email |
amuchandru@ymail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anesthesiology, A2 block, Second floor,
Mahatama Gandhi Medical College and Research Institute, Pondicherry Cuddalore ECR, Pillayarkuppam, Pondicherry, 607402.
|
|
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Primary Sponsor
|
| Name |
Mahatama Gandhi Medical College and Research Institute Pondicherry |
| Address |
Mahatama Gandhi Medical College and Research Institute, Pondicherry, Cuddalore, ECR Road.
|
| 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 |
| Vaibhav Pandey |
Mahatama Gandhi Medical College and Research Institute, Pondicherry. |
Department of Anesthesiology, A2 block, Second floor, Pondicherry Cuddalore ECR, Pillayarkuppam, 607402.
Pondicherry
PONDICHERRY |
9663220844
vaibhavpandey2297@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human 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: O||Medical and Surgical, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Macintosh blade laryngoscope. |
Conventinally used curved blade laryngoscope in adults. |
| Intervention |
Miller Laryngoscope. |
Adult, straight blade Laryngoscope |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Adults 18 - 60 years.
ASA 1 and 2
Elective surgeries requiring General Anaesthesia with Endotracheal intubation. |
|
| ExclusionCriteria |
| Details |
Anticipated difficult airway.
ASA 3 and 4.
Emergency surgeries.
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Ease of intubation with respect to first attempt success rate which is defined as single passage of endotracheal tube without use of assisted manoeuvres like bougie, stylet or backward, upward, rightward pressure. |
Baseline.
Induction.
Immediately after 1st laryngoscopy.
Between 1st and 2nd laryngoscopy.
Immediately after intubation.
1st minute.
2nd minute.
3rd minute.
4th minute.
5th minute. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Cormack Lehane grading.
Time taken for orotracheal intubation.
Hemodynamic parameters such as heart rate, systolic BP, and Mean arterial blood pressure. |
Baseline.
Induction.
Immediately after 1st laryngoscopy.
Between 1st and 2nd laryngoscopy.
Immediately after intubation.
1st minute.
2nd minute.
3rd minute.
4th minute.
5th minute. |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
15/09/2019 |
| 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="0"
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)?
|
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Brief Summary
|
Airway management is the primary responsibility of the Anesthesiologists which is to secure, preserve and protect it during induction and maintainance and recovery from anaesthesia. Laryngoscopy forms an essential component of general anesthesia and endotracheal intubation. The aim of the laryngoscopy is to obtain a good view of the vocal cords and to facilitate smooth oro-tracheal intubation. Therefore to achieve smooth orotracheal intubation Anesthesiologists various techniques such as optimal head and neck position and various kinds of laryngoscopes to get an optimal view of the glottis. Conventionally, Anaesthesiologist use Macintosh blade for adult intubation and Miller blade for pediatric population. In routine practice, Miller laryngoscope is rarely used in adult and therefore very few literature evidence comparing the straight adult Miller and curved Macintosh laryngoscope in terms of orotracheal intubation. Previous study reviews suggested that glottis view is better with the adult Miller blade while ease of orotracheal intubation had inconclusive results. The previous studies based on randomised clinical trial were conducted on two different individuals and there is lack in literature review with respect to crossover design comparing adult Miller and Macintosh laryngoscope. Hence, we have designed a randomised crossover study to compare ease of orotracheal intubation using adult Miller and Macintosh laryngoscope, on the same individual. |