| CTRI Number |
CTRI/2023/03/050833 [Registered on: 20/03/2023] Trial Registered Prospectively |
| Last Modified On: |
04/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Insertion of tube into the wind pipe by new devices |
|
Scientific Title of Study
|
ENDOTRACHEAL INTUBATION BY INTUBATING LARYNGEAL MASK AIRWAY (FASTRACH™) -ALONE OR ASSISTED BY VIDEO ENDOSCOPE (FIVE™) – A RANDOMISED CONTROLLED TRIAL |
| Trial Acronym |
NO |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
HARSHITH S |
| Designation |
junior resident department of Anaesthesiology |
| Affiliation |
vijayanagar institute of medical sciences |
| Address |
Junior resident, Department of Anaesthesiology , vijayanagar institute of medical sciences, cantonment,
Ballari,
KARNATAKA
583104
India
vijayanagar institute of medical sciences, cantonment,
Ballari,
KARNATAKA
583104
India
Bellary
KARNATAKA
583104
India |
| Phone |
9591180430 |
| Fax |
|
| Email |
harshithmurthy96@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DEVANAND B |
| Designation |
Professor and Head of department |
| Affiliation |
vijayanagar institute of medical sciences |
| Address |
Professor and HOD, Department of Anaesthesiology , vijayanagar institute of medical sciences, cantonment,
Ballari,
KARNATAKA
583104
India
vijayanagar institute of medical sciences, cantonment,
Ballari,
KARNATAKA
583104
India
Bellary
KARNATAKA
583104
India |
| Phone |
9845233239 |
| Fax |
|
| Email |
Dr.devanand.b@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
HARSHITH S |
| Designation |
junior resident department of Anaesthesiology |
| Affiliation |
vijayanagar institute of medical sciences |
| Address |
Junior resident, Department of Anaesthesiology , vijayanagar institute of medical sciences, cantonment,
Ballari,
KARNATAKA
583104
India
vijayanagar institute of medical sciences, cantonment,
Ballari,
KARNATAKA
583104
India
Bellary
KARNATAKA
583104
India |
| Phone |
9591180430 |
| Fax |
|
| Email |
harshithmurthy96@gmail.com |
|
|
Source of Monetary or Material Support
|
| vijayanagar institute of medical sciences, cantonment,
Ballari,
KARNATAKA
583104
India |
|
|
Primary Sponsor
|
| Name |
Vijayanagar institute of medical sciences |
| Address |
vijayanagar institute of medical sciences, cantonment,
Ballari,
KARNATAKA
583104
India |
| Type of Sponsor |
Government 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 |
| Harshith s |
Vijayanagar institute of medical sciences |
vijayanagar institute of medical sciences, cantonment,
Ballari,
KARNATAKA
583104
India
Bellary
KARNATAKA |
9591180430
harshithmurthy96@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| vims Ethics commitee |
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 |
| Intervention |
Blind Endotracheal intubation by Fastrach intubating laryngeal mask airway |
Patient is preoxygenated and intubated with fastrach ILMA and the ease of 1st attempt intubation sucess rate along with taken for intubation is measured |
| Comparator Agent |
Endotracheal intubation by fastrach intubating laryngeal mask airway assisted by flexible intubating video laryngoscope |
Patient is preoxygenated and induction agent is given inubating laryneal mask airway is inserted after the visual confirmation by flexible intubating video endoscope the preloaded endotracheal tube is passed and the 1st attempt sucess rate and time taken for intubation is measured |
|
|
Inclusion Criteria
|
| Age From |
18.00 Month(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of 18-55 years of age, of either sex, posted for elective surgeries under general anaesthesia .
2. ASA physical status 1&2
3. Modified Mallampatti (Samsoon and
Young)class I or II
4. BMI <30
5. Mouth opening ≥ 2 fingers
|
|
| ExclusionCriteria |
| Details |
1. Refusal by patients for the procedure.
2. Anticipated difficult airway.
3. Patients with increased risk of aspiration or having a history of symptomatic GERD.
4. Symptoms related to laryngeal pharyngeal anomaly.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| First attempt intubation success rate with the two techniques |
Comparing time taken for intubation with the 2 techniques |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Duration of intubation,
2.Number of Attempts required for successful
intubation
3.Need for additional maneuvers for positioning the ILMA
4. Episodes of desaturation
|
time required, desaturation episodes, maneuvers done from when the ILMA is at level of
mouth to insertion of ILMA and at the interval of1min, 2min,3min,4min,5min after intubation |
|
|
Target Sample Size
|
Total Sample Size="104"
Sample Size from India="104"
Final Enrollment numbers achieved (Total)= "66"
Final Enrollment numbers achieved (India)="66" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
24/03/2023 |
| Date of Study Completion (India) |
22/11/2023 |
| Date of First Enrollment (Global) |
24/03/2023 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Suspended |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
The prime responsibility and aim of any anesthesiologist is the maintenance of airway. From the time endotracheal intubation was introduced, undue problems have occurred due to failed ventilation and tracheal intubation. Many studies have proved that airway mismanagement occurs in most cases due to lack of proper expertise and equipments.
The ILMA was considered as the “gold standard†among the supraglottic airway devices when it was initially released for use. It has showed a high success rate for blind or fibreoptic-guided tracheal intubation in patients with both expected and unexpected difficult airways. Another objective of use of ILMA was to eliminate the need to distort the anterior pharyngeal anatomy in order to visualize the laryngeal inlet, making the device applicable to patients with a history of difficult intubation and a high or anterior larynx.
There are number of studies comparing ILMA with other supraglottic airway devices with respect to obtundation of pressor response, ease of intubation and time taken for intubation. But there is paucity of studies comparing blind intubation with ILMA and intubation with further aided by use of video endoscopes. Hence present study is planned to compare the ease of intubation between intubating laryngeal mask airway (ILMA) alone and that with flexible intubating video endoscope (FIVE). |