| CTRI Number |
CTRI/2025/10/096236 [Registered on: 21/10/2025] Trial Registered Prospectively |
| Last Modified On: |
20/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study comparing video laryngoscope and combined video laryngoscope with flexible bronchoscope method for inserting breathing tube in adults with expected difficult airway. |
|
Scientific Title of Study
|
Comparison of the performance of video laryngoscope with hybrid technique using both video laryngoscope and flexible bronchoscope for endotracheal intubation in adult patients with predicted difficult intubation: A randomized controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ayub Khan |
| Designation |
Postgraduate resident |
| Affiliation |
Lady hardinge medical College and associated hospitals |
| Address |
Department of anaesthesia, Lady hardinge medical College and associated hospitals, Shaheed Bhagat Singh Marg, DIZ Area, Connaught Place, New Delhi
Central DELHI 110001 India |
| Phone |
8447641624 |
| Fax |
|
| Email |
ayubkhan10jan@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Garima Agrawal |
| Designation |
Proffesor |
| Affiliation |
Lady hardinge medical College and associated hospitals |
| Address |
Department of anaesthesia, Lady hardinge medical College and associated hospitals, Shaheed Bhagat Singh Marg, DIZ Area, Connaught Place, New Delhi
Central DELHI 110001 India |
| Phone |
8826640501 |
| Fax |
|
| Email |
garima2396@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Ayub Khan |
| Designation |
Postgraduate resident |
| Affiliation |
Lady hardinge medical College and associated hospitals |
| Address |
Department of anaesthesia, Lady hardinge medical College and associated hospitals, Shaheed Bhagat Singh Marg, DIZ Area, Connaught Place, New Delhi
Central DELHI 110001 India |
| Phone |
8447641624 |
| Fax |
|
| Email |
ayubkhan10jan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Lady hardinge medical College and associated hospitals, Shaheed Bhagat Singh Marg, DIZ Area, Connaught Place, New Delhi, Delhi 110001 |
|
|
Primary Sponsor
|
| Name |
Lady hardinge medical College and associated hospitals |
| Address |
Lady hardinge medical College and associated hospitals, Shaheed Bhagat Singh Marg, DIZ Area, Connaught Place, New Delhi, Delhi 110001 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Ayub Khan |
Eye/ Ent OT |
Sixth floor, Lady hardinge medical College and associated hospitals, Shaheed Bhagat Singh Marg, DIZ Area, Connaught Place, New Delhi 110001 Central DELHI |
8447641624
ayubkhan10jan@gmail.com |
| Ayub Khan |
Gynaecology OT |
Old building first floor, Lady hardinge medical College and associated hospitals, Shaheed Bhagat Singh Marg, DIZ Area, Connaught Place, New Delhi 110001 Central DELHI |
8447641624
ayubkhan10jan@gmail.com |
| Ayub Khan |
Surgery/ Orthopedics OT |
First floor, Lady hardinge medical College and associated hospitals, Shaheed Bhagat Singh Marg, DIZ Area, Connaught Place, New Delhi 110001 Central DELHI |
8447641624
ayubkhan10jan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee for Human Research , LHMC and associated hospitals , New Delhi- 110001 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K00-K95||Diseases of the digestive system, (2) ICD-10 Condition: N00-N99||Diseases of the genitourinary system, (3) ICD-10 Condition: H60-H95||Diseases of the ear and mastoid process, (4) ICD-10 Condition: H00-H59||Diseases of the eye and adnexa, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Hybrid technique using both video laryngoscope and flexible bronchoscope |
After induction of general anesthesia in Group FVL, first the video laryngoscope shall be introduced and once the glottis is visualized, another anesthesia provider shall insert the flexible bronchoscope and taking clues from the video laryngoscopic view, flexible bronchoscopic guided endotracheal intubation shall be performed with appropriately sized PVC tracheal tube. |
| Comparator Agent |
Video laryngoscope |
After induction of general anesthesia in Group VL, Video laryngoscope shall be introduced and once the glottis is visualized, Endotracheal intubation shall be performed with appropriately sized PVC tracheal tube. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA I-II, Scheduled for elective surgery under general anesthesia requiring endotracheal intubation, Patients with difficult airway assessed by senior anesthesiologist as having one or more of the following predictors: Modified Mallampati grade 3 or 4, inability to protrude the jaw, neck circumference greater than 36cm, thyromental distance smaller than 6cm, reduced range of neck flexion and extension |
|
| ExclusionCriteria |
| Details |
Patients with laryngeal or tracheal pathologies and mouth opening smaller than 3cm, Emergency surgery, Pregnant patient |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Proportion of patients with successful first-attempt intubation with video laryngoscope vs hybrid technique using both video laryngoscope and flexible bronchoscope in adult patients with predicted difficult intubation |
Immediately after completion of the first intubation attempt |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Time taken in seconds (Mean ± SD) for tracheal intubation in first attempt in both the groups |
Time from introduction of laryngoscope to the appearance of first square wave capnographic trace in first attempt |
| Proportion of patients with failed intubation in both the groups |
After completion of 2 allowed intubation attempts in each patient. |
| Proportion of patients requiring Optimal External Laryngeal Manipulation for achieving successful intubation in both the groups |
Assessed at the time of intubation attempt |
| Proportion of patients with oro-dental trauma in both the groups |
Assessed during or immediately after intubation |
|
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
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)
|
05/11/2025 |
| 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
|
Study will be conducted after approval from the Institutional Ethical Committee (IEC) and registration with Clinical Trial Registry India (CTRI). A pre-anesthetic checkup shall be done and written informed consent will be obtained from the patient. A senior anaesthesiologist will perform airway assessment to determine the predicted difficult airway as per inclusion criteria mentioned above. Patients shall be kept fasting as per the standard guidelines and will receive premedication as per the decision of anaesthesiologist. In the operation theatre, an intravenous line will be secured and standard monitoring will be attached using a multichannel monitor and baseline parameters consisting of heart rate, peripheral capillary oxygen saturation (SPo2), non-invasive blood pressure (NIBP) shall be recorded. As per standard protocol of managing a difficult airway, a difficult airway cart will be kept and another senior anesthesiologist shall remain on standby while securing the airway. All patients will be positioned in the sniffing position. Patients will be randomized into two groups i.e. Group-VL, Group-FVL (FB+VL). According to the group allotted, the respective devices shall be prepared. In Group VL an endotracheal tube (ETT) loaded over a stylet shall be kept ready and in Group FVL an ETT loaded over the flexible bronchoscope shall be kept ready. A standard anesthetic technique will be adopted for all patients. Patients will receive injection fentanyl 2 µg/kg iv and general anesthesia will be induced with injection propofol 2-2.5 mg/kg i.v. After checking adequacy of mask ventilation, muscle relaxation will be achieved with injection rocuronium 0.6 mg/kg iv and tracheal intubation will be attempted after 3 minutes of intermittent positive pressure ventilation (IPPV) with oxygen and 2% sevoflurane, with an appropriately sized PVC tracheal tube by C-MAC video laryngoscope in Group VL. In Group FVL, first the VL shall be introduced and once the glottis is visualized, another anesthesia provider shall insert the FB and taking clues from the VL view, FB guided intubation shall be performed. The intubation will be performed by a senior anesthesiologist experienced for at least 10 years with both the devices. Tube position will be checked by auscultation and confirmed by capnography. Time taken for tracheal intubation will be defined as the time from introduction of laryngoscope to the appearance of first square wave capnographic trace. Time taken for tracheal intubation will be recorded by stopwatch. Optimal External Laryngeal Manipulation (OELM) shall be allowed for achieving successful intubation and number of patients requiring application of this maneuver will be recorded. Any evidence of oro-dental trauma in terms of injury to lips, teeth, gums, and mucosa of the oropharynx shall be observed and recorded while withdrawing the device after the endotracheal intubation is achieved. After successful tracheal intubation, anesthesia will be maintained with sevoflurane in air and oxygen along with top ups of inj. rocuronium. Failure of intubation shall be defined if more than two attempts are taken to secure the airway with either of the 2 techniques. In such a situation the airway will be secured as per the anesthesiologist discretion and the patient will be excluded from the study. Intraoperative hemodynamics will be managed in accordance with surgical procedure and blood loss. Trachea will be extubated as per standard protocol using inj. neostigmine 0.05 mg/kg iv and inj. glycopyrolate 0.01 mg/kg iv. |