| CTRI Number |
CTRI/2021/09/036654 [Registered on: 20/09/2021] Trial Registered Prospectively |
| Last Modified On: |
15/09/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
Changes in intracuff pressure using Blockbuster Supraglottic Airway device in two different positions |
|
Scientific Title of Study
|
A Comparative Evaluation of Changes in Intracuff Pressure using Blockbuster Supraglottic Airway Device in Trendenlenburg position and Reverse Trendenlenburg Position in Patients Undergoing Laproscopic Surgery |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nidhi Thakur |
| Designation |
Junior resident |
| Affiliation |
Dr.RPGMC Tanda |
| Address |
Department of Anaesthesia
Dr.RPGMC Tanda
Distt Kangra
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
9779600752 |
| Fax |
|
| Email |
doc.nidhithakur89@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dheeraj singha |
| Designation |
Associate Professor |
| Affiliation |
Dr.RPGMC Tanda |
| Address |
Department of Anaesthesia
Dr.RPGMC Tanda
Distt Kangra
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
8091048700 |
| Fax |
|
| Email |
dheerajsingha@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nidhi Thakur |
| Designation |
Junior resident |
| Affiliation |
Dr.RPGMC Tanda |
| Address |
Department of Anaesthesia
Dr.RPGMC Tanda
Distt Kangra
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
9779600752 |
| Fax |
|
| Email |
doc.nidhithakur89@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
DrNidhi Thakur |
| Address |
Department Of Anaesthesia
Dr.RPGMC Tanda Kangra |
| 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 |
| Dr Nidhi Thakur |
Dr. RPGMC Tanda , Kangra |
Third Floor OT complex, Department of Anaesthesia
Kangra
HIMACHAL PRADESH |
9779600752
doc.nidhithakur89@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
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 |
Blockbuster Supraglottic Airway Device |
Second Generation Supraglottic Airway device |
| Comparator Agent |
Intracuff pressure |
Change in Intracuff pressure in Trendenlenburg and Reverse Trendenlenburg position in Laproscopic surgery lasting for 60 to 120 minutes |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
BMI 18.5 to 30
ASA I and ASA II
Elective laproscopic surgery with an anticipated duration of 30 to 120 mins |
|
| ExclusionCriteria |
| Details |
obesity (BMI) > 30
Oropharyngeal pathology
Limited mouth opening
Laproscopic surgery converted to open surgery
H/O low pulmonary compliance |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine cuff pressure in laproscopic surgeries in Trendenlenburg and reverse Trendenlenburg position with Blockbuster SGA |
30 to 120 mins |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
to compare haemodynamic changes.
to compare the airway dynamics
to evaluate quality of extubation |
30 mins to 48 hrs |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
N/A |
|
Date of First Enrollment (India)
|
21/09/2021 |
| 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="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
patients will be classified in two groups , group A and group B trendenlenburg and reverse trendenlenburg position respectively. Patient of either group will be taken in OT after Midnight fasting. patient will be monitored with ECG, oxygen saturation, EtCO2,NIBP. Patient will be induced under GA and Supraglottic airway device will be insertesd after jaw relaxation. Intracuff pressure will be monitored using cuff Manometer. |