| CTRI Number |
CTRI/2024/11/076346 [Registered on: 06/11/2024] Trial Registered Prospectively |
| Last Modified On: |
06/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to compare efficiency of D-Stylet and rigid stylet using videolaryngoscope in difficult intubation cases |
|
Scientific Title of Study
|
Comparison of D-Stylet and rigid stylet using videolaryngoscope in difficult intubation |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shikha Gupta |
| Designation |
Professor Anaesthesia |
| Affiliation |
Dayanand Medical College and Hospital |
| Address |
Department of Anaesthesia Dayanand Medical College and Hospital
Civil Lines Ludhiana 141001 Punjab India Ludhiana PUNJAB
141001 India
Ludhiana
PUNJAB
141001
India
Ludhiana
PUNJAB
141001
India |
| Phone |
9814820622 |
| Fax |
|
| Email |
shikhadmc@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ajay Kumar |
| Designation |
PG Resident Anaesthesia |
| Affiliation |
Dayanand Medical College and Hospital |
| Address |
Department of Anaesthesia Dayanand Medical College and Hospital
Civil Lines Ludhiana 141001 Punjab India Ludhiana PUNJAB
141001 India
Ludhiana
PUNJAB
141001
India
Ludhiana
PUNJAB
141001
India |
| Phone |
7973356187 |
| Fax |
|
| Email |
akay7589@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ajay Kumar |
| Designation |
PG Resident Anaesthesia |
| Affiliation |
Dayanand Medical College and Hospital |
| Address |
Department of Anaesthesia Dayanand Medical College and Hospital
Civil Lines Ludhiana 141001 Punjab India Ludhiana PUNJAB
141001 India
Ludhiana
PUNJAB
141001
India
Ludhiana
PUNJAB
141001
India |
| Phone |
7973356187 |
| Fax |
|
| Email |
akay7589@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dayanand Medical College and Hospital Ludhiana 141001 Punjab INDIA
|
|
|
Primary Sponsor
|
| Name |
Dayanand Medical college and Hospital |
| Address |
Tagore Nagar, Civil lines, Ludhiana. 141001 Punjab India |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Dr Shikha Gupta |
Dayanad Medical College and Hospital |
Department of
Anaesthesia Dayanand
Medical College and
Hospital Tagore Nagar,
Civil Lines Ludhiana
141001 Ludhiana
PUNJAB
Ludhiana
PUNJAB
Ludhiana
PUNJAB |
9814820622
shikhadmc@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research and Ethical Committee Dayanand Medical College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 8||Other Procedures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
D Stylet intubation |
In anticipated difficult intubation patients, video-laryngoscopic intubation will be done using D Stylet |
| Comparator Agent |
Rigid stylet intubation |
In anticipated difficult intubation patients, video-laryngoscopic intubation will be done using portex Rigid stylet |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1.Age more than or equal to 18 yrs
2.Either sex
3.American Society of Anaesthesiologists grade 1-4
4.Patients with Anticipated difficult airway more than 6
|
|
| ExclusionCriteria |
| Details |
1.Known airway pathology
2.Head and neck known malignancy
3.Immobilized cervical spine
4.Pregnancy
5.Increased risk of regurgitation and aspiration of gastric contents
6.Patient refusal
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparison of successful Endotracheal tube time between videolaryngoscopic inubation using D Sylet and Portex Rigid Stylet |
Time used between receiving the styleted endotracheal tube in the laryngoscopists hand and the successful passage of black line on endotracheal tube just beyond the vocal cord, measured in seconds. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Difference in total intubation time, number of attempts for successful intubation, hemodynamic changes, and any airway trauma between both the groups |
Total intubation time- From start to end of intubation procedure.
Number of attempts-Number of attempts recorded as part of procedure.
Hemodynamic changes-after induction, immediately post-intubation (0 min) and at 1, 5, and 10-minutes post-intubation.
Airway trauma- immediately post intubation |
|
|
Target Sample Size
|
Total Sample Size="232"
Sample Size from India="232"
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 4 |
|
Date of First Enrollment (India)
|
21/11/2024 |
| 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="6"
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
|
The use of stylet with an endotracheal tube (ETT) in anticipated difficult airway patients using videolaryngoscope(VL) has decreased the incidence of failed intubations. Commonly used Portex® rigid stylet forms a fixed shape and curvature of ETT, which at times does not match with the angle and curvature of the D-blade C-MAC videolaryngoscope. This necessitates the withdrawal of ETT-stylet assembly for reshaping. On the other hand, the D-stylet has an easily controllable flexible tip, which can be used as a dynamic aid to tailor the ETT shape and its tip can be altered as required by the intubating personnel according to the angle of the D-Blade. A prospective, interventional, single-blinded study will be conducted on a total of 232 patients having anticipated difficult airway undergoing elective tracheal intubation with a D-blade videolaryngoscope. The patients will be divided into the following two groups- In group D intubation will be done on 116 patients using D-Stylet while Portex® rigid stylet will be used in Group P on the other 116 patients. Aim of our study is the Comparison of D-stylet with rigid stylet as a dynamic aid to facilitate intubation in anticipated difficult airway using a D-blade videolaryngoscope. The primary outcome of our study is difference in ETT negotiation time between both groups and the secondary outcome is difference in total intubation time, number of attempts for successful intubation, hemodynamic changes, and any airway trauma between both the groups. |