| CTRI Number |
CTRI/2022/12/048313 [Registered on: 20/12/2022] Trial Registered Prospectively |
| Last Modified On: |
17/12/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
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Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
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Public Title of Study
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Comparative evaluation of effect of application of external maneuvers with no maneuver on glottis view during videolaryngoscopy in patients undergoing elective surgery with head in neutral position. |
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Scientific Title of Study
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A comparative evaluation of application of external maneuvers, jaw thrust and burp with no maneuvers during videolaryngoscopy on glottis view with head in neutral position in patients undergoing elective surgery.
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| Trial Acronym |
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR SIPALI PANDA |
| Designation |
Post Graduate Resident |
| Affiliation |
Safdarjung Hospital and Vardhman Mahavir Medical College |
| Address |
Department of Anaesthesiology and Intensive Care, Ground Floor, Main Operation Theatre Building, Vardhman Mahavir Medical College And Safdarjung Hospital
New Delhi
DELHI
110029
India |
| Phone |
7656869621 |
| Fax |
|
| Email |
sipali4321.panda@gmail.com |
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Details of Contact Person
Scientific Query
|
| Name |
DR NIDHI AGRAWAL |
| Designation |
Consultant |
| Affiliation |
Safdarjung Hospital and Vardhman Mahavir Medical College |
| Address |
Department of Anaesthesiology and Intensive Care, Ground Floor, Main Operation Theatre Building, Vardhman Mahavir Medical College And Safdarjung Hospital
New Delhi
DELHI
110029
India |
| Phone |
9811030408 |
| Fax |
|
| Email |
nidhi.agrawal1970@gmail.com |
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Details of Contact Person
Public Query
|
| Name |
DR SIPALI PANDA |
| Designation |
Post Graduate Resident |
| Affiliation |
Safdarjung Hospital and Vardhman Mahavir Medical College |
| Address |
Department of Anaesthesiology and Intensive Care, Ground Floor, Main Operation Theatre Building, Vardhman Mahavir Medical College And Safdarjung Hospital
New Delhi
DELHI
110029
India |
| Phone |
7656869621 |
| Fax |
|
| Email |
sipali4321.panda@gmail.com |
|
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Source of Monetary or Material Support
|
| Vardhman Mahavir Medical College and Safdarjung Hospital,New Delhi,India |
|
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Primary Sponsor
|
| Name |
Safdarjung Hospital and Vardhman Mahavir Medical College |
| Address |
Department of Anaesthesiology and Intensive Care, Ground Floor, Main Operation Theatre Building, Vardhman Mahavir Medical College And Safdarjung Hospital
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| Type of Sponsor |
Government medical college |
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Details of Secondary Sponsor
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Countries of Recruitment
|
India |
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Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| SIPALI PANDA |
Safdarjung Hospital and Vardhman Mahavir Medical College |
Department of Anaesthesiology and Intensive Care Ground Floor Main Operation Theatre Building Vardhman Mahavir Medical College And Safdarjung Hospital
New Delhi
South
DELHI |
7656869621
sipali4321.panda@gmail.com |
|
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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
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| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
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Intervention / Comparator Agent
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| Type |
Name |
Details |
| Intervention |
External maneuver -Jaw thrust |
Group J patients will be intubated using C-MAC videolaryngoscope Macintosh blade applying external maneuver jaw thrust for glottis visualisation and endotracheal tube intubation . Laryngoscopic view will be graded by intubating anaesthesiologist in terms of POGO score ,modified Cormack-Lehane grade and glottis opening area in pixel squared. The tracheal intubation will be considered as successful in presence of appearance of square waveform capnographic trace on the monitor and bilateral equal breath sounds on chest auscultation. |
| Intervention |
External maneuver-BURP |
Group B patients will be intubated using C-MAC videolaryngoscope Macintosh blade applying external maneuver BURP for glottis visualisation and endotracheal tube intubation . Laryngoscopic view will be graded by intubating anaesthesiologist in terms of POGO score ,modified Cormack-Lehane grade and glottis opening area in pixel squared. The tracheal intubation will be considered as successful in presence of appearance of square waveform capnographic trace on the monitor and bilateral equal breath sounds on chest auscultation. |
| Comparator Agent |
Without external maneuver |
Group C patients will be intubated using C-MAC videolaryngoscope Macintosh blade without applying any external maneuver for glottis visualisation and endotracheal tube intubation . Laryngoscopic view will be graded by intubating anaesthesiologist in terms of POGO score ,modified Cormack-Lehane grade and glottis opening area in pixel squared. The tracheal intubation will be considered as successful in presence of appearance of square waveform capnographic trace on the monitor and bilateral equal breath sounds on chest auscultation. |
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Inclusion Criteria
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| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
This study will be conducted in adult patients, in age group of 18 to 65 years, American society of Anaesthesiologists (ASA) physical status I and II undergoing elective surgery under general anaesthesia with endotracheal intubation with controlled ventilation
|
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| ExclusionCriteria |
| Details |
1) Patients with anticipated difficult airway
2) Cervical spine pathology
3) High risk of aspiration
4) Poor dentition with high risk of damage
5) Pregnancy
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Method of Generating Random Sequence
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Permuted block randomization, fixed |
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Method of Concealment
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Sequentially numbered, sealed, opaque envelopes |
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Blinding/Masking
|
Participant Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
| POGO SCORE |
At the time of intubation |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| Modified Cormack Lehane grading of glottis view, glottis opening area in pixel squared, total time taken to secure the airway, success rate of intubation, number of intubation attempts and ease of intubation. |
At the time of intubation |
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Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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 |
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Date of First Enrollment (India)
|
22/12/2022 |
| 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 |
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Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
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Recruitment Status of Trial (Global)
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Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
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Individual Participant Data (IPD) Sharing Statement
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Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
|
Endotracheal intubation is the gold standard method of intubation in patients undergoing general anaesthesia. This can be achieved with classic direct laryngoscope or videolaryngoscope. In classic direct laryngoscope the head and neck of the patient requires to be kept in sniffing position to align the oral, pharyngeal and laryngeal axes in one line. Videolaryngoscopes are indirect laryngoscopes which do not require sniffing position. Neutral position of head and neck is used for intubation in patients with suspected or actual cervical spine instability. External maneuvers like jaw thrust and BURP provide a better glottis view and aid in laryngoscopy. Therefore in this study we will compare the effect of application of external maneuvers i.e. jaw thrust and BURP during C-MAC videolaryngoscopy on glottis view in terms of POGO score to that obtained with no maneuvers in patients undergoing elective surgery with head in neutral position. |