| CTRI Number |
CTRI/2025/09/094457 [Registered on: 09/09/2025] Trial Registered Prospectively |
| Last Modified On: |
09/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of two airway adjuncts in airway tube insertion on cervical spine movement in patients requiring videolaryngoscopic intubation under anesthesia. |
|
Scientific Title of Study
|
The effect of Flexible tip Bougie vs. Stylet on Cervical Spine Motion during video laryngoscopic intubation under Manual Inline Stabilisation: 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 |
Priyanka |
| Designation |
Junior Resident |
| Affiliation |
AIIMS Bhubaneswaer |
| Address |
1st floor, Hospital building, Department of Anaesthesiology and Critical Care, AIIMS Bhubaneswar, Sijua, Patrapada,
Bhubaneswar.
Khordha
ORISSA
751019
India |
| Phone |
9443213344 |
| Fax |
|
| Email |
priyankaabuddingmedico@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Nitasha Mishra |
| Designation |
Associate Professor |
| Affiliation |
AIIMS Bhubaneswar |
| Address |
1st floor, Hospital building, Department of Anaesthesiology and Critical Care, AIIMS Bhubaneswar, Sijua, Patrapada,
Bhubaneswar.
Khordha
ORISSA
751019
India |
| Phone |
8373938016 |
| Fax |
|
| Email |
nitsmishra@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Nitasha Mishra |
| Designation |
Associate Professor |
| Affiliation |
AIIMS Bhubaneswar |
| Address |
1st floor, Hospital building, Department of Anaesthesiology and Critical Care, AIIMS Bhubaneswar, Sijua, Patrapada,
Bhubaneswar.
Khordha
ORISSA
751019
India |
| Phone |
8373938016 |
| Fax |
|
| Email |
nitsmishra@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Department of Anesthesiology and Critical care, AIIMS , Bhubaneswar |
| Address |
1st floor, Hospital building,AIIMS, Sijua, Patrapada, Bhubaneswar, Odisha- 751019. |
| 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 |
| Priyanka |
AIIMS Bhubnaeswar |
Room no 158, Department of Anesthesiology,
1st floor, Hospital Building AIIMS, Bhubaneswar ,Odisha pin code ; 751019
Khordha
ORISSA |
9443213344
priyankaabuddingmedico@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute ethics committee, AIIMS, Bhubaneswar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue, (2) ICD-10 Condition: G00-G99||Diseases of the nervous system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Flexible tip bougie |
Flexible tip bougie has a steerable tip that helps in endotracheal intubation in cases of difficult airway. The endotracheal tube is then railroaded on the bougie. |
| Comparator Agent |
Stylet |
Stylet is a malleable rod that is inserted into endotracheal tube. Maintains the endotracheal tube in fixed shape. It is used during management of difficult airway. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients scheduled for cervical spine surgery or Neuro intervention procedures. ASA grade 1,2 and 3 patients
|
|
| ExclusionCriteria |
| Details |
Oral tumours
Airway bleed
Pregnant
Children
Hemodynamic instability
Mouth opening less than 2.5 cm
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Difference in cervical spine motion- in degrees at the Occiput–C1 segment.
|
T1 is Baseline
T2 is during videolaryngoscopy with a POGO score of atleast 50%
T3 is during endotracheal tube advancement.
Cervical spine motion at T2 and T3 is compared with T1. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Cervical spine motion at:
C1–C2 segment & C2–C5 segment.
2.Time taken for successful intubation
3.First-attempt success rate
4.Percentage Of Glottic Opening (POGO) score
5.Intubation Difficulty Score (IDS)
|
1.Baseline
2. during laryngoscopy
3. during tube intubation |
|
|
Target Sample Size
|
Total Sample Size="52"
Sample Size from India="52"
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)
|
01/10/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/10/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Cervical spine motion , particularly at the Occiput–C1 segment, has a risk of neurological deterioration during tracheal intubation in patients with cervical spine pathology. In order to minimize this risk, Manual In-Line Stabilization or cervical collars are routinely employed. Both the techniques reduce cervical motion at the cost of making the airway management difficult. Video laryngoscopy is increasingly preferred over Fiberoptic Bronchoscopy (FOB) due to comparable cervical spine safety and higher first-pass success rates. However, intubation often requires adjuncts such as stylet or bougie, each with its own mechanical profiles. Studies comparing the efficacy of stylet and bougie on the intubation success rate are present. However, the effect of bougie and stylet on cervical spine motion remains unstudied. Both glottic exposure and tube advancement contribute to cervical spine motion. This study aims to fill this gap by comparing cervical spine motion during videolaryngoscopy (VDL) -guided intubation using a Flexible tip bougie and a Stylet under Manual In-Line Stabilization (MILS). The findings will aid anaesthesiologists in selecting lower-risk intubation techniques for patients with cervical spine instability and may help inform future airway management guidelines. This randomized controlled trial is designed to compare the cervical spine movement during videolaryngoscopy guided intubation using either a flexible tip bougie or a stylet in patients undergoing cervical spine surgery or neurointerventional procedures under general anesthesia, with the hypothesis that flexible tip bougie guided intubation results in lesser cervical spine motion.
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