| CTRI Number |
CTRI/2022/02/040280 [Registered on: 14/02/2022] Trial Registered Prospectively |
| Last Modified On: |
06/03/2023 |
| 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
|
Comparison of performance of LMA Protector and LMA Proseal as airway management in anaesthetized paralyzed patients |
|
Scientific Title of Study
|
Comparison of performance of LMA Protector and LMA Proseal in anaesthetized paralyzed patients |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mamta Bhardwaj |
| Designation |
Associate Professor |
| Affiliation |
Pt. BDS University of Health Sciences |
| Address |
New Modular Ot complex, Department of anaesthesiology and critical care, PGIMS Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
9812789476 |
| Fax |
|
| Email |
drmamta@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mamta Bhardwaj |
| Designation |
Associate Professor |
| Affiliation |
Pt. BDS University of Health Sciences |
| Address |
New Modular Ot complex, Department of anaesthesiology and critical care, PGIMS Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
9812789476 |
| Fax |
|
| Email |
drmamta@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sunny |
| Designation |
post Graduate Student |
| Affiliation |
Pt. BDS University of Health Sciences |
| Address |
New Modular Ot complex, Department of anaesthesiology and critical care, PGIMS Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
7988289898 |
| Fax |
|
| Email |
sunnydhania85@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology, Pt. BDS PGIMS, ROHTAK |
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
NA |
| Type of Sponsor |
Other [NA] |
|
|
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 |
| Sunny |
Pt. BDS PGIMS |
New modular OT complex,
2nd floor
Department of Anaesthesiology, Pt. BDS PGIMS, Rohtak
Rohtak
HARYANA |
7988289898
sunnydhania85@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Biomedical Research Ethics Committee, UHS, Rohtak |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: K00-K95||Diseases of the digestive system, (2) ICD-10 Condition: C509||Malignant neoplasm of breast of unspecified site, (3) ICD-10 Condition: H748||Other specified disorders of middle ear and mastoid, (4) ICD-10 Condition: H188||Other specified disorders of cornea, (5) ICD-10 Condition: N813||Complete uterovaginal prolapse, (6) ICD-10 Condition: N838||Other noninflammatory disorders ofovary, fallopian tube and broad ligament, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
LMA Proseal in anaesthetized paralyzed patients |
clinical performance of LMA Proseal in anaesthetized paralyzed patients |
| Intervention |
LMA Protector in anaesthetized paralyzed patients |
clinical performance of LMA Protector in anaesthetized paralyzed patients |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
ASA- I to III undergoing elective surgery under general anaesthesia with airway management using supraglottic airway device in supine position. |
|
| ExclusionCriteria |
| Details |
Patients with known difficult airway, edentulous, BMI > 30 kg/ m2, upper airway pathology,
mouth opening <3.2cm, known gastroesophageal reflux, increased risk of aspiration, recent
upper respiratory tract infection and patient refusal to participate, will be excluded from the
study |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare oropharyngeal leak pressure of LMA Protector and LMA Proseal |
0mins,30mins, 60mins, 90mins, 120mins, 150mins,180mins, 24hr
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Insertion characteristics (number of insertion attempts, ease of insertion, success rate,
amount of air required for cuff inflation)
2. Positioning outcomes (fiberoptic view scoring, gastric tube placement)
3. Hemodynamic parameters
4. Postoperative complications (blood stains on device, sore throat, hoarseness of voice,
dysphagia) |
0mins,30mins, 60mins, 90mins, 120mins, 150mins,180mins, 24hr
|
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "90"
Final Enrollment numbers achieved (India)="90" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/02/2022 |
| Date of Study Completion (India) |
31/08/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| 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
|
The LMA Protector is the latest innovation from the
inventors of the laryngeal mask. The device has a fixation system which
prevents proximal displacement during use ensuring that
the distal end seals around the upper oesophageal sphincter. Preliminary
clinical trials of the LMA-Protector have shown that it is easy to insert and provides
a reliable and adequate seal. A recent primary evaluation of the LMA-Protector reported
that the device provides a high pharyngeal seal. However, its performance particularly
airway sealing effect, has not been compared with other well-identified supraglottic
airway devices such as the LMA Proseal. LMA Proseal has been widely used in
clinical practice and has been reported to show a better or comparable
performance including
airway sealing effect compared to previous LMA devices. We hypothesize that LMA-Protector
will provide comparable clinical efficacy and safety as the PLMA and so the purpose
of the study is to compare the clinical performance of the LMA-Protector and
the PLMA
in terms of oropharyngeal seal pressure and insertion characteristic. |