| CTRI Number |
CTRI/2025/03/082577 [Registered on: 18/03/2025] Trial Registered Prospectively |
| Last Modified On: |
16/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A study comparing how well three different airway devices—i-gel, Blockbuster, and Ambu Aura LMA—help patients breathe during short surgeries. |
|
Scientific Title of Study
|
Comparative study to determine the efficacy of i-gel, BlockBuster, and Ambu Aura as ventilatory devices in short surgical procedures. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ashish Bisht |
| Designation |
junior resident 2 |
| Affiliation |
Government medical college, Haldwani |
| Address |
Depatment of Anaesthesiology, critical care, pain and palliative medicine, 2nd floor susheela tiwari hospital, Haldwani
Nainital
UTTARANCHAL
263139
India |
| Phone |
9461903995 |
| Fax |
|
| Email |
Dr.ashibisht@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Geeta Bandari |
| Designation |
Professor and HOD, Department of anaesthesiology |
| Affiliation |
Government medical college, Haldwani |
| Address |
Depatment 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 |
Dr Geeta Bandari |
| Designation |
Professor and HOD, Department of anaesthesiology |
| Affiliation |
Government medical college, Haldwani |
| Address |
Depatment 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 |
|
|
Source of Monetary or Material Support
|
| Department of anaesthesialogy, critical care, pain and palliative medicine, Susheela Tiwari Government hospital, haldwani, uttrakhand, 263139 |
|
|
Primary Sponsor
|
| Name |
Dr. Ashish Bisht |
| Address |
Department of anaesthesialogy, critical care, pain and palliative medicine, Susheela Tiwari Government hospital, haldwani, uttrakhand, 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 Ashish Bisht |
Susheela Tiwari Hospital |
Department of anesthesiology, critical care, pain and palliative medicine, 2nd floor, Susheela Tiwari Government hospital, haldwani, Uttarakhand, 263139
Nainital
UTTARANCHAL |
9461903995
dr.ashibisht@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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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: N00-N99||Diseases of the genitourinary system, (6) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Ambu Aura |
The study population is divided into 3 groups of 30 patients each.
Group I used i-gel as a ventilatory device; Group B used BlockBuster as a ventilatory device; and Group A used Ambu Aura as a ventilatory device instead of traditional endotracheal intubation.
In group A using Ambu Aura, oropharyngeal leak pressure and other parameters such as vitals, side effects, etc. will be compared with other LMA used as a ventilatory device instead of endotracheal intubation.
|
| Comparator Agent |
BlockBuster |
The study population is divided into 3 groups of 30 patients each.
Group I used i-gel as a ventilatory device; Group B used BlockBuster as a ventilatory device; and Group A used Ambu Aura as a ventilatory device instead of traditional endotracheal intubation.
In group B using BlockBuster, oropharyngeal leak pressure and other parameters such as vitals, side effects, etc. will be compared with other LMA used as a ventilatory device instead of endotracheal intubation.
|
| Intervention |
i-gel |
The study population is divided into 3 groups of 30 patients each.
Group I used i-gel as a ventilatory device; Group B used BlockBuster as a ventilatory device; and Group A used Ambu Aura as a ventilatory device instead of traditional endotracheal intubation.
In group I using i-gel, oropharyngeal leak pressure and other parameters such as vitals, side effects, etc. will be compared with other LMA used as a ventilatory device instead of endotracheal intubation.
|
|
|
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 short surgeries (less than 90mins) under general anesthesia.
3.Age of the patient between 18-65 of either sex.
4.Patients belonging to American Society of Anesthesiologists- physical status I or II.
5.Patients belonging to Modified Mallampati class I and II.
|
|
| ExclusionCriteria |
| Details |
1.Patients with predicted difficult airway such as mouth opening less than 2 cm, (oropharynx, larynx) pathology.
2.Patients with head injury, psychiatric disorder, respiratory tract, endocrine disorder, patients with risk of regurgitation such as gastroesophageal reflux disease, hiatus hernia, esophageal varices, pregnant patient etc.
3.Patient who are obese (BMI more than 35 kg/m2)
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the oropharyngeal leak pressure for providing airway seal pressure of i-gel, BlockBuster, and Ambu Aura. |
After 5 minutes of positioning and fixation of the device, oropharyngeal leak pressure will be assessed. It will be measured by palpable or audible leak of gas in suprasternal notch and auscultation of epigastrium after closing the expiratory valve of the circle system to 30 cm of H2O at a fixed gas flow (only O2) of 6 L/min and airway pressure at steady state noted on the visual pressure gauge included in modern anesthesia machines. We will not permit it to exceed 30 cm of H2O. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare effective airway insertion time, number of insertions attempts and ease of insertion of device and gastric tube. |
|
| To compare hemodynamics & ventilatory parameters, intraoperative & post-operative complications (oral trauma, sore throat, dyspnea etc.) during use of the devices, if any |
Vital parameters like pulse rate, blood pressure, SpO2, EtCO2, & ventilator parameters will be noted at baseline (0 minutes) after induction of anesthesia, after insertion, 10 minutes after insertion, & immediately after removal of the device & after completion of surgery. |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
29/03/2025 |
| 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 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
|
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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 i-gel, Ambu aura, Blockbuster, 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 three groups of 30 each. Group i used i-gel , Group A used Ambu Aura, 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
|