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
|
|
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
|
|
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. |