| CTRI Number |
CTRI/2025/05/087275 [Registered on: 21/05/2025] Trial Registered Prospectively |
| Last Modified On: |
16/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
Study to assess efficacy of blockbuster LMA for ventilation and intubation |
|
Scientific Title of Study
|
A Study To Assess Efficacy Of Blockbuster LMA For Ventilation And 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 |
Shahil Ahmed |
| Designation |
Junior Resident 2 |
| Affiliation |
Government Medical College,Haldwani |
| Address |
Department of Anaesthesiology,critical care,pain and palliative medicine,2nd floor,Susheela Tiwari hospital,Haldwani,
Nainital
UTTARANCHAL
263139
India |
| Phone |
8851246362 |
| Fax |
|
| Email |
asahil786326@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Geeta Bhandari |
| Designation |
Professor and HOD,department of anesthesiology |
| Affiliation |
Government Medical College,Haldwani |
| Address |
Department of Anaesthesiology,critical care,pain and palliative medicine,2nd floor,Susheela Tiwari hospital,Haldwani,
Nainital
UTTARANCHAL
263139
India |
| Phone |
8650655556 |
| Fax |
|
| Email |
bhandari_geetantl@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shahil Ahmed |
| Designation |
Junior Resident 2 |
| Affiliation |
Government Medical College,Haldwani |
| Address |
Department of Anaesthesiology,critical care,pain and palliative medicine,2nd floor,Susheela Tiwari hospital,Haldwani,
Nainital
UTTARANCHAL
263139
India |
| Phone |
8851246362 |
| Fax |
|
| Email |
asahil786326@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of anaesthesiology,critical care,pain and palliative medicine,Susheela tiwari hospital,Haldwani,Uttarakhand-263139 |
|
|
Primary Sponsor
|
| Name |
Dr Shahil ahmed |
| Address |
Department of anaesthesiology,critical care,pain and palliative medicine,Susheela tiwari hospital,Haldwani,Uttarakhand-263139 |
| Type of Sponsor |
Other [Self] |
|
|
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 Shahil Ahmed |
Susheela tiwari hospital |
Department of Anaesthesiology,critical care,pain and palliative medicine,2nd floor,Susheela Tiwari hospital,Haldwani,
Nainital
UTTARANCHAL |
08851246362
asahil786326@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC,GMC,HALDWANI |
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: H60-H95||Diseases of the ear and mastoid process, (3) ICD-10 Condition: H00-H59||Diseases of the eye and adnexa, (4) ICD-10 Condition: N00-N99||Diseases of the genitourinary system, (5) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Blockbuster LMA |
The study of 200 patients.Group B used Blockbuster as ventilatory device in 1-2 minutes |
| Comparator Agent |
Blockbuster LMA |
The study of 200 patients.Group B used Blockbuster as ventilatory device within 1 minutes |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients giving informed written consent for participation in the study.
2. Patients posted for surgery under general anesthesia.
3. Age of the patient between 18-65 of either sex.
4. Patients belonging to American Society of Anaesthesiology class I and II.
5. Patients belonging to Modified Mallampatti Score of class I and II.
|
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
•To study the first attempt successful intubation done using blockbuster LMAs and NG insertion.
|
24hrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
•The time of LMA insertion & LMA removal.
•Any intra-op & post-op complications occurring using LMAs.
•To observe hemodynamic changes during insertion of LMAs
|
2hrs,8hs,24 hrs |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
29/05/2025 |
| 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 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
|
The present study is a Prospective, Randomized and Comparative study done after approval of Institutional Ethics Committee in patients satisfying all inclusion and exclusion Criteria planned for short surgeries under GA. Material used were Blockbuster LMA, Anaesthesia workstation, suction apparatus, Laryngoscope and ET Tubes of various sizes. After careful preoperative assessment of all patients’ standard monitors including NIBP, ECG, and pulse oximeter will be attached to the patient. The study population is divided into single group of 200 patients. Group B used Blockbuster as ventilatory device. In the operating room, an 18G IV cannula is inserted into both hands. Ringer lactate solution is infused at 10ml/kg. Patients receive 100% oxygen for 3 minutes, followed by premedication. Standard monitoring is connected. Anesthesia is induced with propofol and vecuronium and maintained with oxygen, nitrous oxide, and sevoflurane after introducing allocated SAD. parameters like-successful insertion time, number of attempts of insertion, oropharyngeal leak pressure and vitals like- pulse rate, blood pressure, SpO2 , EtCO2 and ventilator parameters will be noted before induction of anesthesia, throughout surgery and immediately after removal of the device after completion of surgery |