| CTRI Number |
CTRI/2024/09/073828 [Registered on: 12/09/2024] Trial Registered Prospectively |
| Last Modified On: |
06/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
It is a study to compare success rate of endotracheal intubation through BlockBusterTM LMA in right versus left lateral decubitus position |
|
Scientific Title of Study
|
Comparison of ease of endotracheal intubation through blockbuster LMA in right vs left lateral decubitus position |
| 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 Preeti Gehlaut |
| Designation |
Professor |
| Affiliation |
PT.B.D Sharma PGIMS, Rohtak |
| Address |
Department of Anaesthesiology and Critical Care,Modular OT complex second floor,,Pt.B.D Sharma PGIMS, Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
8950285434 |
| Fax |
|
| Email |
preeti.gehlaut@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pritam kumari |
| Designation |
Junior Resident |
| Affiliation |
Pt.B.D Sharma PGIMS, Rohtak |
| Address |
Department of Anaesthesiology and Critical Care,Modular OT complex second floor,,Pt.B.D Sharma PGIMS, Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
08708973267 |
| Fax |
|
| Email |
pritamkumari036@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pritam kumari |
| Designation |
Junior Resident |
| Affiliation |
Pt.B.D Sharma PGIMS, Rohtak |
| Address |
Department of Anaesthesiology and Critical Care,Modular OT complex second floor,,Pt.B.D Sharma PGIMS, Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
08708973267 |
| Fax |
|
| Email |
pritamkumari036@gmail.com |
|
|
Source of Monetary or Material Support
|
| PT.B.D Sharma PGIMS, Rohtak
Pin code -124001
Haryana
India
|
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesiology and Critical Care |
| Address |
Department of Anaesthesiology and Critical Care,Modular OT complex second floor,Pt.B.D Sharma PGIMS, Rohtak
Pin code -124001
Haryana
India |
| Type of Sponsor |
Government medical college |
|
|
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 Pritam kumari |
PT.B.D Sharma PGIMS, Rohtak |
Department of Anaesthesiology and Critical Care, Modular OT complex second floor,Pt. B.D Sharma PGIMS, Rohtak
Rohtak
HARYANA |
08708973267
pritamkumari036@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Biomedical research ethics committee, Pt.B.D Sharma PGIMS Rohtak |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 4||Measurement and Monitoring, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Comparison of ease of endotracheal intubation in right vs left lateral decubitus position |
Comparison of ease of endotracheal intubation through BlockBusterTM LMA in right versus left lateral decubitus position in patients undergoing general surgery .
After 5 min on intubation, patient will be placed supine or in the desired position of surgery |
| Comparator Agent |
Left and right lateral decubitus position. |
To compare ease of endotracheal intubation through BlockbusterTM LMA in right versus left lasteral decubitus position |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
50 patients in the age group of 18-65 years belonging to ASA 1 and 2 undergoing surgery under general anesthesia requiring endotracheal Intubation |
|
| ExclusionCriteria |
| Details |
Airway pathology, cervical spine pathology, facial and tongue anomalies or any other airway anomaly,refusal to participate,pregnant women,unable to lie down in lateral position due to any reason will be excluded from the study |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparison of first attempt success rate of endotracheal intubation through BlockBusterTM LMA in right versus left lateral decubitus position LMA in right versus left |
For BlockBusterTM LMA placement
1.Baseline
2.During insertion
3.After insertion
For Endotracheal intubation
1.During intubation
2.After 1 minute
3.After 5 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
For BlockBusterTM LMA
1.Ease of LMA insertion
2.Time taken to insert
3.Oropharyngeal leak pressure (OLP)
4.Numbers of attempts
5.Overall sucess rate of placement
For endotracheal intubation through BlockBusterTM LMA
1.Ease of endotracheal intubation
2.Numbers of attempts
3.Overall sucess rate of intubation
4.Complications,if any |
For BlockBusterTM LMA placement
1.Baseline
2.Before insertion
3.During insertion
4.After insertion
For endotracheal intubation
1.Baseline
2.During intubation
3.1minutes after intubation
4.5minutes after intubation
|
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
25/09/2024 |
| 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 - NO
|
|
Brief Summary
|
Endotracheal intubation is the gold standard in airway management , often performed in patients in a supine position. This position easily accessible and manageable , especially in emergencies like haemodynamic instability, arrythmias, cardiac arrest, seizures, pulmonary embolism, acute desaturation, and accidental extubation. However, supine position during surgery is not always possible for all patients and may require neuromuscular blockade, trauma to the airway, awareness under anaesthesia, and failure to establish an airway, leading to hypoxia and death. Previous studies have have shown successful ventilation and intubation in lateral position, including laryngeal mask airway, intubating laryngeal mask airway. We conduct a study to compare the ease of endotracheal intubation through Blockbuster LMA in Right vs Left lateral decubitus position. The study will involve 50 patients aged 18-65, weighing 40kg to 70 kg , scheduled for elective surgery under general anaesthesia. Patients with airway pathology, facial and tongue anomalies, restricted mouth opening, previous tracheostomization, refusal to participate, pregnant women, or unable to lie down in lateral position will be excluded. Patients will be randomly allocated to one of two groups: Group Right (25) and Group Left (25), with Blockbuster LMA insertion and endotracheal intubation in the right and left decubitus position. Anaesthesia monitoring will include HR,NIBP,ECG,SpO2, and EtCO2. The anaesthesiologist performing the procedure will use their right and left hand for the right and left - sided Blockbuster LMA placement and intubations. |