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CTRI Number  CTRI/2025/05/086973 [Registered on: 15/05/2025] Trial Registered Prospectively
Last Modified On: 14/05/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of video assisted fiber-optic bronchoscopy with hyperangulated video laryngoscopy for first attempt success rate of intubation  
Scientific Title of Study   Comparison of video laryngoscope-assisted fiber-optic bronchoscopy with hyperangulated video laryngoscopy for first attempt success rate of oro-tracheal intubation in patients with difficult airway: randomised 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  Ayya Syama Sundar 
Designation  Additional Professor 
Affiliation  AIIMS Bibinagar 
Address  Depart Of Anaesthesiology, AIIMS Bibinagar, Yadadri Bhuvanagiri district

Hyderabad
TELANGANA
508126
India 
Phone  8179309677  
Fax    
Email  sasyasyama@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Ayya Syama Sundar 
Designation  Additional Professor 
Affiliation  AIIMS Bibinagar 
Address  Depart Of Anaesthesiology, AIIMS Bibinagar, Yadadri Bhuvanagiri district

Hyderabad
TELANGANA
508126
India 
Phone  8179309677  
Fax    
Email  sasyasyama@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Ayya Syama Sundar 
Designation  Additional Professor 
Affiliation  AIIMS Bibinagar 
Address  Depart Of Anaesthesiology, AIIMS Bibinagar, Yadadri Bhuvanagiri district

Hyderabad
TELANGANA
508126
India 
Phone  8179309677  
Fax    
Email  sasyasyama@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences, Bibinagar, yadadri Bhongiri district, Telangana,India, pincode: 508126 
 
Primary Sponsor  
Name  AIIMS Bibinagar 
Address  Department of Anaesthesiology AIIMS BIBINAGAR, Yadadri Bhongiri District Hyderabad, Telangana, India, pincode:508126  
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Ayya Syama Sundar  AIIMS Bibinagar  Department of Anaesthesiology AIIMS BIBINAGAR, Yadadri Bhongiri District Hyderabad, Telangana, India, pincode:508126
Nalgonda
TELANGANA 
8179309677

sasyasyama@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE (AIIMS BBN IEC)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Hyperangulated Video Laryngoscopy guided for tracheal intubation   Hyperangulated Video Laryngoscopy will be used for anticipated difficult airway patients for intubation. the use of hyperangulated laryngosopy is only for the intubation time only. 
Intervention  Video-laryngoscope-Assisted Fiber-optic Bronchoscopy for tracheal intubation   Video-laryngoscope-Assisted Fiber-optic Bronchoscopy will be used for anticipated difficult airway patients for intubation. this intervention is only for the intubation time only. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Patients having difficult airway (defined as modified mallampati grading more than 3 and 4) undergoing general anaesthesia requiring endotracheal intubation. 
 
ExclusionCriteria 
Details  Pregnancy or any other risk of aspiration which necessitates rapid sequence intubation.
Mouth opening less than 2 cm
Planned awake or nasal intubation
Elective nasal intubation
Emergency surgery
Patients who do not consent for the study
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To determine the first attempt intubation success rates of Video-laryngoscope-Assisted Fiber-optic Bronchoscopic intubation VAFOBI and Hyperangulated Video Laryngoscopic intubation (VLS) in patients with anticipated difficult airway  immediately after succesful intubation. (within 3 minutes) 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the ease of intubation between the two methods  immediately after tracheal intubation (within 3 minutes) 
To determine the time taken to intubate

 
Time period from insertion of blade into oral cavity to appearance of ETCO2 will be noted  
Hemodynamic response to intubation  Baseline (immediately before intubation), after that every two minutes for atleast 3 readings after successful intubation. 
Incidence of airway injury and post-operative sore throat  24 hours following surgery 
 
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   Post Marketing Surveillance 
Date of First Enrollment (India)   31/05/2025 
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="2"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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  

The study will commence after receiving approval from institutional research committee, institutional ethics committee and CTRI. Based on the inclusion criteria, patients will be recruited for the study. Written informed consent of patients will be taken after giving a detailed information about our study in terms of nature of study, the benefits and risks involved. Fiber optic intubation, despite being the current gold standard for anticipated difficult airway, does not provide a 100% success rate. . One of the main problems with fiber optic intubation, the narrow pharynx, can be solved through simultaneous direct or video laryngoscopy with elevation of the oropharynx. This is also helpful in case of tongue swelling or presentation with a large epiglottis. Therefore, VAFI helps the two instruments complement each other’s shortcomings. Hence VAFI has even been suggested to be includedin the difficult airway algorithm –non-emergent pathway. this study aimed to Video-laryngoscope-assisted fiber-optic bronchoscopic oro-tracheal intubation superior to hyperangulated video –laryngoscopic intubation in terms of first attempt success rate. Pre- anaesthetic evaluation along with anticipated difficult airway will be done prior to day of surgery.After shifting patient onto operation theatre table, in supine position, patient will be pre-oxygenated for 3 minutes followed by induction with Fentanyl 2mcg/kg and Propofol 2-3mg/kg titrated to loss of consciousness. Once mask ventilation is found to be successful, muscle relaxant Rocuronium 0.6mg/kg IBW will be given. The operator will then be informed of the group allotment of the patient. Patient will be intubated with an endo-tracheal tube of appropriate size under video laryngoscopy (C-MAC with D-Blade (Karl Storz, Tuttlingen, Germany)) with the help of preformed stylet (C-MAC GUIDE, D-BLADE (Karl Storz, Tuttlingen, Germany)) or FOB (EB-580S (FUJIFILM Co., Tokyo, Japan)(outer diameter : 5.3mm) based on group allotment. Two operators will be involved in case of VAFOBI group. Time period from insertion of blade into oral cavity to appearance of ETCO2 will be noted, which indicates successful intubation. The attempt will be considered a failure if VLS is removed from the oral cavity or if Spo2 drops below 90% before achieving intubation. Patient will then be handed over to the surgeon for the surgery. The operator will then be enquired about the ease of intubation on a Likert scale. After surgery, all patients will be shifted to PACU (post anaesthetic care unit). Patients will be discharged from PACU after complete recovery. all patients receive standard care during the study period.

 
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