| CTRI Number |
CTRI/2022/09/045457 [Registered on: 13/09/2022] Trial Registered Prospectively |
| Last Modified On: |
11/09/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare the duration to intubate a patient with a direct Macintosh laryngoscope and C-mac videolaryngoscope using the Intubation box. |
|
Scientific Title of Study
|
A comparative evaluation of conventional Macintosh laryngoscope and C-MAC video laryngoscope using an aerosol box: A prospective randomized study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sobia Manaal Siddiqui |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal Nehru Medical College and Hospiatl |
| Address |
Department of Anaesthesiology and Critical Care, Jawaharlal Nehru Medical College and Hospital
Aligarh Muslim University, Aligarh
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
9760703491 |
| Fax |
|
| Email |
sobiamanaal510@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Obaid Ahmed Siddiqui |
| Designation |
Associate Professor |
| Affiliation |
Jawaharlal Nehru Medical College and Hospiatl |
| Address |
Department of Anaesthesiology and Critical Care, Jawaharlal Nehru Medical College and Hospital
Aligarh Muslim University, Aligarh
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
9897695761 |
| Fax |
|
| Email |
obaidahmad2008@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sobia Manaal Siddiqui |
| Designation |
Junior Resident 3 |
| Affiliation |
Jawaharlal Nehru Medical College and Hospiatl |
| Address |
Department of Anaesthesiology and Critical Care, Jawaharlal Nehru Medical College and Hospital
Aligarh Muslim University, Aligarh
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
9760703491 |
| Fax |
|
| Email |
sobiamanaal510@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology and Critical Care, Jawaharlal Nehru Medical College and Hospital, Aligarh Muslim University, Aligarh |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesiology and Critical Care |
| Address |
Department of Anaesthesiology and Critical Care, Jawaharlal Nehru Medical College and Hospital, Aligarh Muslim University, Aligarh |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Sobia Manaal Siddiqui |
Jawaharlal Nehru Medical College and Hospital |
Department of Anaesthesiology and Critical Care, Jawaharlal Nehru Medical College and Hospital, Aligarh Muslim University, Aligarh
Aligarh
UTTAR PRADESH |
9760703491
sobiamanaal510@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
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, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
C-MAC videolaryngoscope with aerosol box |
The time from initial insertion of the laryngoscope in the mouth to the first lung inflation with positive pressure breaths using an anaesthesia bag through the tracheal tube with an inflated cuff. |
| Intervention |
Conventional Macintosh Laryngoscope with aerosol box |
The time from initial insertion of the laryngoscope in the mouth to the first lung inflation with positive pressure breaths using an anaesthesia bag through the tracheal tube with an inflated cuff. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
ASA Grade I & II, BMI - <30, MP class – 1 & 2
|
|
| ExclusionCriteria |
| Details |
Decreased inter-incisor distance (<3 cm), Short thyromental distance (<6 cm), Any facial anomaly, Fixed flexion deformity, Patient at risk of pulmonary aspiration
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcome measure shall be the time required for a successful tracheal intubation. |
Insertion of laryngoscope till immediately post intubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The number of intubation attempts, Intubation difficulty score, The rate of successful placement of the TT in the trachea, Number of optimization maneuvers required (use of a bougie, external laryngeal pressure) to aid in tracheal intubation, The Cormack Lehane grade at laryngoscopy, Hemodynamic changes during intubation, The Percentage Of Glottic Opening (POGO) score at laryngoscopy, Immediate complications
|
The number of intubation attempts - 1, 2 or 3
Intubation difficulty score - 0 to 8
The Cormack Lehane grade at laryngoscopy - 1 to 4
Hemodynamic changes during intubation - pre-induction, post-intubation, and after 3 minutes and 5 minutes
The Percentage Of Glottic Opening (POGO) score at laryngoscopy - 0%, 25-50%, 50-75% and 100%
Immediate complications - blood on the endotracheal tube, dental trauma, esophageal intubation, and sore throat in the immediate postoperative period.
|
|
|
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" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
15/09/2022 |
| 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 |
|
Estimated Duration of Trial
|
Years="0"
Months="8"
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)?
Response - NO
|
|
Brief Summary
|
A comparative evaluation of conventional Macintosh
laryngoscope and C-MAC video laryngoscope using an aerosol box: A prospective
randomized study. The incidence of respiratory illnesses is on the rise.
In most of these infections, airway secretions and aerosol generation is the
source of spread [1]. Often healthcare workers
in the peripheral regions work under low resource settings and don’t have
adequate protective equipment to safeguard themselves against infections by
employing various innovations in their practice and protocols. The Aerosol box is one such innovation which is a
cheap and easy to make acrylic box that can be used as a barrier between the
patient and the healthcare provider. Videolaryngoscopes have been preferred choice in
many studies because of various advantages and assumption that they take lesser
time to intubate and offer better glottic visualization. However, in patients
with normal airway and without aerosol box, it has been found that a good
visualization is not always related to a good success rate. The success rate
and intubation times were comparable to conventional laryngoscopes in many such
studies. The evidence on real
patients is lacking and there is relative scarcity of literature on patients as
subjects. It is imperative to know the best way to intubate a patient using an
aerosol box in order to save time and resources.
Therefore, we
designed this study with the primary aim to compare the intubation time between a
conventional Macintosh laryngoscope and C-MAC videolaryngoscope using an
aerosol box in patients with normal airway.
|