| CTRI Number |
CTRI/2024/05/066672 [Registered on: 02/05/2024] Trial Registered Prospectively |
| Last Modified On: |
01/05/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To evaluate the efficacy of two human airway devices - Baska mask and LMA Protector used for anesthetizing patients. |
|
Scientific Title of Study
|
To evaluate the efficacy of Baska mask and LMA Protector in anesthetized paralysed patients – a prospective randomized comparative study. |
| 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 Ruchi Saxena |
| Designation |
Assistant professor |
| Affiliation |
Kalyan Singh Superspeciality Cancer Institute |
| Address |
Department of Anesthesia,
Kalyan Singh Superspeciality Cancer Institute,
C.G.City, Sultanpur Road , Lucknow
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
09140366422 |
| Fax |
|
| Email |
taru_ruchi@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ruchi Saxena |
| Designation |
Assistant professor |
| Affiliation |
Kalyan Singh Superspeciality Cancer Institute |
| Address |
Department of Anesthesia,
Kalyan Singh Superspeciality Cancer Institute,
C.G.City, Sultanpur Road , Lucknow
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
09140366422 |
| Fax |
|
| Email |
taru_ruchi@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ruchi Saxena |
| Designation |
Assistant professor |
| Affiliation |
Kalyan Singh Superspeciality Cancer Institute |
| Address |
Department of Anesthesia,
Kalyan Singh Superspeciality Cancer Institute,
C.G.City, Sultanpur Road , Lucknow
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
09140366422 |
| Fax |
|
| Email |
taru_ruchi@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Kalyan Singh Superspeciality Cancer Institute,
C.G.City, Sultanpur Road , Lucknow, Uttar Pradesh, INDIA
226002 |
|
|
Primary Sponsor
|
| Name |
Kalyan Singh Superspeciality cancer institute |
| Address |
Kalyan Singh Superspeciality cancer institute
C.G.city, Sultanpur Road,
Lucknow, Uttar Pradesh, INDIA
226002 |
| 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 |
| Dr Ruchi Saxena |
Kalyan Singh Superspeciality cancer institute |
Department of Anesthesia,
Kalyan Singh Superspeciality cancer institute
C.G.city, sultanpur road, Lucknow, Utaar Pradesh
Lucknow
UTTAR PRADESH |
09140366422
taru_ruchi@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Kalyan Singh Superspeciality Cancer Institute, Lucknow |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D099||Carcinoma in situ, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Baska Mask, type of supraglottic airway device. |
Baska Mask will be inserted for maintaining the airway during anesthesia and various parameters will be recorded to judge its efficacy. It will be kept for the duration of surgery and then removed on completion of surgery.
then the parameters of two airways will be compared with each other. |
| Intervention |
Insertion of LMA protector to maintain airway during anesthesia for surgeries lasting less than two hours. |
LMA Protector will be inserted for maintaining the airway during anesthesia and various parameters will be recorded to judge its efficacy. It will be kept for the duration of surgery and then removed on completion of surgery. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
18- 65 years
all patients Scheduled for elective surgery under general anaesthesia in supine position with expected duration of surgery less than 2 hours. |
|
| ExclusionCriteria |
| Details |
1. Upper airway anatomic variation or pathology.
2. Predicted difficult airway
3. High risk of aspiration (full stomach, gastroesophageal reflux, Pregnancy)
4. Body mass index greater than 30 kg/m2,
5. Patient refusal to participate
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Oropharyngeal leak pressure during positive pressure ventilation.
This outcome measure was used for sample size calculation. |
it will be assessed only once immediately after insertion and once successful ventilation is confirmed. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. First attempt success rate.
2. Accuracy of size as per manufacturer recommendation.
3. Insertion time.
4. Ease of gastric tube placement.
5. Anatomic position of device.
6. Presence of blood & gastric contents on the device.
7. Incidence & severity of postoperative sore throat at 1h, 4h & 24 h after surgery.
8. Ease of insertion of SGAD.
|
1. Secondary outcome measures numbered 1-5,8 will be assessed immediately after insertion, only once.
2.Secondary outcome measure number 6, will be assessed at the end of surgery.
3. Secondary outcome measures number 7 will be assessed at 1h, 4h & 24 h after surgery.
|
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
12/05/2024 |
| 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="0"
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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) - taru_ruchi@yahoo.co.in
- For how long will this data be available start date provided 01-07-2024 and end date provided 01-04-2028?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
The supraglottic airway devices (SGAD) are widely used
for airway management in anaesthetic field, critical care and emergency
situations like difficult airway management. Since their introduction, several
innovative devices have been developed depending on shape, functioning channels
and cuff.
Baska maskTM (BM) is novel SGAD with self-sealing membranous cuff that
inflates during inspiration and partially deflates during expiration.
It has two drain channels proximally, opening into the large integral sump
cavity distally, at the upper oesophagus.
LMA-Protectorâ„¢ is relatively new SGAD with inflatable
cuff integrated with Cuff Pilotâ„¢ technology for easier and continuous
adjustment of the intracuff pressure. Similar to BM, it has two drain channels
which narrows distally into common orifice communicating with the upper
oesophageal sphincter.
Both the devices had been evaluated in limited
studies. The two devices are similar in design except cuff. BM has got
self-sealing cuff while LMA protector has inflatable cuff with continuous
monitoring of cuff pressure, so we hypothesize that oropharyngeal sealing
pressures might be comparable. Currently, there is no available literature
comparing the efficacy of BM with LMA protector.
In our study, we aim to compare BM and LMA protector
in terms of clinical efficacy like adequacy of airway seal, insertion time,
ease and accuracy of insertion, and the incidence of postoperative sore throat and
other complications, in paralyzed and anesthetized patients. |