| CTRI Number |
CTRI/2025/07/091370 [Registered on: 22/07/2025] Trial Registered Prospectively |
| Last Modified On: |
21/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of conditions for insertion of endotracheal tube using ProVu™ video laryngoscope versus Macintosh laryngoscope for nasotracheal intubation |
|
Scientific Title of Study
|
Comparison of intubating conditions using ProVu™ video laryngoscope versus Macintosh laryngoscope for nasotracheal intubation- A Randomized Controlled Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ruchi Kapoor |
| Designation |
Professor |
| Affiliation |
UCMS and GTB Hospital |
| Address |
Room no. 731 A, 7th floor, OT Block, Department of Anaesthesiology and Critical Care, UCMS and GTB Hospital, Delhi
North East
DELHI
110095
India |
| Phone |
9560678023 |
| Fax |
|
| Email |
rudoc@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ruchi Kapoor |
| Designation |
Professor |
| Affiliation |
UCMS and GTB Hospital |
| Address |
Room no. 731 A, 7th floor, OT Block, Department of Anaesthesiology and Critical Care, UCMS and GTB Hospital, Delhi
DELHI
110095
India |
| Phone |
9560678023 |
| Fax |
|
| Email |
rudoc@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ritika |
| Designation |
Post Graduate Resident |
| Affiliation |
UCMS and GTB Hospital |
| Address |
2nd Floor, OT Block, Department of Anaesthesiology and Critical Care, UCMS and GTB Hospital, Delhi
North East
DELHI
110095
India |
| Phone |
8700415582 |
| Fax |
|
| Email |
ritikarao9599@gmail.com |
|
|
Source of Monetary or Material Support
|
| UCMS and GTB Hospital, Delhi-110095 |
|
|
Primary Sponsor
|
| Name |
UCMS and GTB Hospital |
| Address |
UCMS and GTB Hospital, Dilshad Garden, Delhi-110095 |
| 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 |
| Dr Ruchi Kapoor |
UCMS and GTB Hospital |
2nd Floor, OT Block, Department of Anaesthesiology and Critical Care, Dilshad Garden-110095
North East
DELHI |
9560678023
rudoc@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee- Human Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Direct Laryngoscopy |
Each patient will undergo nasotracheal intubation using Macintosh laryngoscope |
| Intervention |
Video Laryngoscopy |
Each patient will undergo nasotracheal intubation using ProVu™ video laryngoscope |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Consenting ASA class 1 and 2 adults 18 to 60 years of age for elective surgeries who require nasotracheal intubation under general anaesthesia.
2. Patients with a BMI less than 30 kg per m2. |
|
| ExclusionCriteria |
| Details |
1. Mouth opening less than 2 finger breadth.
2. Limited neck extension.
3. Patients with risk of aspiration like pregnant females, patients of abdominal trauma, intestinal obstruction, hiatus hernia, GERD and patients with a known history of delayed gastric emptying.
4. Patients with visible swelling around the neck. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the time to successful intubation in the two groups. |
Once after intubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| POGO (Percentage of Glottic Opening) score |
Once after intubation |
| Intubation difficulty score |
Once after intubation |
| Fremantle score |
Once after intubation |
| Number of attempts required to intubate |
Once after intubation |
| Hemodynamic parameters |
Baseline: just before induction
T1: post induction
T2: pre intubation
T3: post intubation
T4: 3 minutes post intubation
T5: 5 minutes post intubation
T6: 10 minutes post intubation
T7: 15 minutes post intubation
T8: 30 minutes post intubation |
| Trauma occurring during the intubation process |
Once after intubation |
| Additional maneuvers needed to facilitate intubation |
Once after intubation |
|
|
Target Sample Size
|
Total Sample Size="44"
Sample Size from India="44"
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)
|
18/08/2025 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Although direct laryngoscopes continue to be used as the standard intubating aid, various studies have shown that video laryngoscopes offer advantages over direct laryngoscopes like a better visualization of the vocal cords and lesser time taken to intubate successfully using the latter. Studies have been done to compare the ease of intubation using video and direct laryngoscopy, but, by far, no study has been conducted to compare ProVu™ video laryngoscope with Macintosh laryngoscope in adult patients. Therefore, the present randomized single blinded control study is aimed at comparing the ease of intubation using the aforementioned laryngoscopes. |