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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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 
 
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.
 
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