| CTRI Number |
CTRI/2014/09/004960 [Registered on: 02/09/2014] Trial Registered Retrospectively |
| Last Modified On: |
14/07/2016 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
A study to determine which is the better posture the patient should be lying in to get the better view in the laryngoscope (an instrument for inserting tube in the larynx or voice box) |
|
Scientific Title of Study
|
PROSPECTIVE RANDOMIZED CROSSOVER COMPARATIVE STUDY OF DIRECT LARYNGOSCOPIC VIEW IN SNIFFING AND 25 DEGREES BACKUP POSITION |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rajashree Agaskar |
| Designation |
Consultant Anesthesiologist |
| Affiliation |
Jaslok Hospital and Research Centre |
| Address |
Department of Anesthesiology
Jaslok Hospital and Research Centre
15 Dr. G. Deshmukh Marg
Mumbai
Mumbai MAHARASHTRA 400026 India |
| Phone |
9820143148 |
| Fax |
|
| Email |
rdagaskar@yahoo.co.in |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Sadhana Srivastava |
| Designation |
Primary DNB trainee |
| Affiliation |
Jaslok Hospital and Research Centre |
| Address |
Department of Anesthesiology
Jaslok Hospital and Research Centre
15 Dr. G. Deshmukh Marg
Mumbai
Mumbai MAHARASHTRA 400026 India |
| Phone |
9833620861 |
| Fax |
|
| Email |
sadhana.srivastava@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Rajashree Agaskar |
| Designation |
Consultant Anesthesiologist |
| Affiliation |
Jaslok Hospital and Research Centre |
| Address |
Department of Anesthesiology
Jaslok Hospital and Research Centre
15 Dr. G. Deshmukh Marg
Mumbai
Mumbai MAHARASHTRA 400026 India |
| Phone |
9820143148 |
| Fax |
|
| Email |
rdagaskar@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Department of Anesthesia, Jaslok Hospital and Research Centre Mumbai. |
|
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Primary Sponsor
|
| Name |
Jaslok Hospital and Research Centre |
| Address |
15 Dr.G. Deshmukh Marg
Mumbai 400026 |
| Type of Sponsor |
Research institution and hospital |
|
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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 Rajashree Agaskar |
Jaslok Hospital and Research Centre |
department of anaesthesia, O.T. complex, 18th floor, jaslok hospital and research centre, 15 Dr. G. Deshmukh Marg
Mumbai Mumbai MAHARASHTRA |
9820143148
rdagaskar@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee, Jaslok Hospital and Research Centre |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
direct laryngoscopic view and ease of intubation under general anaesthesia., |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
25 Degrees Back Up Position |
Direct laryngoscopy will be done in 25 Degrees Back Up Position and evaluation of modified Cormack Lehane grade. |
| Comparator Agent |
Sniffing Position |
Direct laryngoscopy wil be done in Sniffing Position and evaluation of modified Cormack Lehane grade. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients scheduled to receive General Anaesthesia with endotracheal intubation.
2. ASA Grade I, II and III
3. Malampatti Classification I, II, III
4. Body Mass Index ( BMI) < 35 Kg/m2
5. Patients giving informed consent
|
|
| ExclusionCriteria |
| Details |
1. Patients refusal
2. ASA Grade IV.
3. Malampatti Classification IV
4. Anticipated difficult airway.
5. Patients with loose teeth
6. Body mass index more than 35 Kg/m2
7. Patients with cervical spine disease
8. Condition requiring rapid sequence intubation.
9. Patients with severe cardiovascular disease.
10. Coagulopathy or patient on anticoagulant therapy.
11. Raised intracranial tension.
12. Pregnant females
|
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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 |
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Primary Outcome
|
| Outcome |
TimePoints |
| laryngeal view (Modified Cormack Lehane Grade) during direct larngoscopy (L1 and L2) in sniffing and 25 degrees back up position |
at the end of laryngoscopy |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Pillow height required to achieve optimal sniffing (external auditory meatus to sternal notch) position.
|
at the end of giving sniffing position
|
| Intubation Difficulty Scale |
after intubation |
|
|
Target Sample Size
|
Total Sample Size="100" Sample Size from India="100"
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)
|
04/03/2014 |
| 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="2" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Closed to Recruitment of Participants |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
With
this study we want to evaluate whether laryngoscopic view is better in 25
degrees back up position as compared to sniffing position? B. J. Lee et al in
2007 have shown that during laryngoscopy, the laryngeal view, as assessed by
Percentage of glottis opening (POGO) scores, improves significantly in the 25
degrees back-up position when compared with the flat supine position.
However 25 degrees back-up position has not been compared with the sniffing
position which is standard of care for direct laryngoscopy. The aim of
this study is to evaluate the effect of 25 degree back up position on laryngeal
view compared with the sniffing position during direct laryngoscopy. The
primary objective is to compare the laryngeal view in both positions by by
modified Cormack – Lehane grading. Secondary Objectives are to compare the
laryngeal view in both positions after applying external laryngeal pressure if necessary, to compare the
difficulty in intubation with the help of Intubation Difficulty Scale(IDS) and to find out the mode value of
pillow height required to achieve optimal sniffing ( external auditory meatus
to sternal notch ) position. 100 adult patients ASA I, II and III physical
status posted for surgery under general anaesthesia with endotracheal
intubation will be studied. A detailed preanaesthetic evaluation of airway will
be performed which includes BMI, thyromental distance, interincisor gap and
modified Mallampatti grading, and adequacy of neck movement.
Patients will be randomized as Group S where intubation will be done in
sniffing position and Group B where intubation will be done in 25 degrees
backup position. Laryngoscopy will be performed in both positions in each
patient followed by endotracheal intubation. Glottic visualization will be
assessed by modified Cormack Lehane classification. Intubation
Difficulty Scale (IDS) will assess the intubation difficulty.
|