| CTRI Number |
CTRI/2018/05/014217 [Registered on: 30/05/2018] Trial Registered Retrospectively |
| Last Modified On: |
17/03/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective Randomised Observational Study |
| Study Design |
Cluster Randomized Trial |
|
Public Title of Study
|
COMPARISON OF EFFECTIVENESS AND SAFETY BETWEEN ENDOTRACHEAL TUBE AND LARYNGEAL MASK AIRWAY-PROSEALTM IN PATIENTS UNDERGOING SURGERY IN PRONE POSITION |
|
Scientific Title of Study
|
Comparison Of Efficacy And Safety Between Endotracheal Tube And Laryngeal Mask Airway-ProsealTM Patients Undergoing Surgery In Prone Position - A Prospective, Randomised, Observational Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kanmani T L |
| Designation |
Junior resident in Anaesthesiology |
| Affiliation |
SDM College Of Medical Sciences and Hospital |
| Address |
Department of Anaesthesia, 2nd Floor, SDM College Of Medical Sciences and Hospital, Sattur, Dharwad
Dharwad
KARNATAKA
580009
India |
| Phone |
9986537663 |
| Fax |
|
| Email |
kanmani15@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Harihar V Hegde |
| Designation |
Professor in Department of Anaesthesiology |
| Affiliation |
SDM College Of Medical Sciences and Hospital |
| Address |
Department of Anaesthesia, 2nd Floor, SDM College Of Medical Sciences and Hospital, Sattur, Dharwad
Dharwad
KARNATAKA
580009
India |
| Phone |
9480724841 |
| Fax |
|
| Email |
drharryhegde@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kanmani T L |
| Designation |
Junior resident in Anaesthesiology |
| Affiliation |
SDM College Of Medical Sciences and Hospital |
| Address |
Department of Anaesthesia, 2nd Floor, SDM College Of Medical Sciences and Hospital, Sattur, Dharwad
Dharwad
KARNATAKA
580009
India |
| Phone |
9986537663 |
| Fax |
|
| Email |
kanmani15@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia, SDM College of Medical Sciences and Hospital, Manjushree Nagar, Sattur, Dharwad-580009 |
|
|
Primary Sponsor
|
| Name |
SDM College of Medical Sciences and Hospital |
| Address |
SDM College of Medical Sciences and Hospital, Sattur, Dharwad 580009, Karnataka |
| Type of Sponsor |
Private 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 Kanmani T L |
SDM College of Medical Sciences and Hospital |
SDMCMCH, Manjushree Nagar, Sattur, Dharwad 580009
Dharwad
KARNATAKA |
9986537663
kanmani15@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SDM Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
ASA 1 - 3, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Undergoing surgery in prone position
3. ASA physical status 1 to 3
|
|
| ExclusionCriteria |
| Details |
1. Anticipated difficult airway
2. BMI ≥ 30
3. Patients not consenting for the study
4. Pregnancy or breast feeding females
5. Patients with present history of sore
throat or dysphagia
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Efficacy of PLMA in prone position
1. Leak pressure (cmH2O)
2. Ventilatory characteristics assessed by Tidal volume (VT) (ml), Respiratory rate (RR) (cycles/min), Minute Volume (MV) (litres), Peak [Ppeak] and mean airway pressure [Pmean] (cmH2O), compliance (ml/cmH2O).
|
0-supine
1-prone
2-30 minutes
3-60 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Safety of PLMA in prone position
1. Number of attempts at insertion
2. Time taken for insertion
3. Intraoperative complications: inadequate ventilation (ETCO2 45 mmHg), desaturation (SpO2 94%), displacement obstruction, aspiration, airway injury, bronchospasm
4. Postoperative complications: coughing, breath holding, laryngospasm, bronchospasm, sore throat, dysphagia, hoarseness of voice, post-operative nausea and vomiting (PONV)
|
Post operative- 2 hours and 24 hours |
|
|
Target Sample Size
|
Total Sample Size="48"
Sample Size from India="48"
Final Enrollment numbers achieved (Total)= "48"
Final Enrollment numbers achieved (India)="48" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/12/2015 |
| Date of Study Completion (India) |
28/04/2017 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="10"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a prospective, randomized, observational study comparing the safety and efficacy of endotracheal tube and Laryngeal Mask Airway – ProsealTM during a period between December 2015 and October 2017 in 48 patients that will be conducted in India. The primary outcome measures will be to see the efficacy of PLMA in prone position. The secondary outcomes will be to see the safety of PLMA in prone position. |