| CTRI Number |
CTRI/2018/12/016712 [Registered on: 18/12/2018] Trial Registered Prospectively |
| Last Modified On: |
21/06/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
CONFIRMATION OF AIRWAY SECURITY USING ULTRASOUND UNDER ANAESTHESIA |
|
Scientific Title of Study
|
CONFIRMATION OF PROSEAL SUPRAGLOTTIC AIRWAY DEVICE PLACEMENT BY LEAK TEST, ULTRASOUND AND FIBEROPTIC BRONCHOSCOPE |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SACHIN E A |
| Designation |
DNB SR |
| Affiliation |
MAX SMART SUPER SPECIALTY HOSPITAL |
| Address |
ROOM NO.1 SECOND FLOOR
DEPARTMENT OF ANAESTHESIA
MAX SMART SUPER SPECILAITY HOSPITAL, PRESS ENCLAVE ROAD
SAKET,NEW DELHI
New Delhi DELHI 110017 India |
| Phone |
7042934401 |
| Fax |
|
| Email |
drsachin@live.com |
|
Details of Contact Person Scientific Query
|
| Name |
DRARCHANA PURI |
| Designation |
SENIOR CONSULTANT |
| Affiliation |
MAX SMART SUPER SPECIALTY HOSPITAL |
| Address |
ROOM NO.1 SECOND FLOOR
DEPARTMENT OF ANAESTHESIA
MAX SMART SUPER SPECILAITY HOSPITAL
PRESS ENCLAVE ROAD
SAKET NEW DELHI
New Delhi DELHI 110017 India |
| Phone |
98130085923 |
| Fax |
|
| Email |
DR.ARCHANA.PURI@GMAIL.COM |
|
Details of Contact Person Public Query
|
| Name |
SACHIN E A |
| Designation |
DNB SR |
| Affiliation |
MAX SMART SUPER SPECIALTY HOSPITAL |
| Address |
ROOM NO.1 SECOND FLOOR
DEPARTMENT OF ANAESTHESIA
MAX SMART SUPER SPECILAITY HOSPITAL, PRESS ENCLAVE ROAD
SAKET,NEW DELHI
New Delhi DELHI 110017 India |
| Phone |
7042934401 |
| Fax |
|
| Email |
drsachin@live.com |
|
|
Source of Monetary or Material Support
|
| MAX SMART SUPER SPECIALTY HOSPITAL, SAKET,NEW DELHI |
|
|
Primary Sponsor
|
| Name |
MAX SMART SUPER SPECIALITY HOSPITAL |
| Address |
PRESS ENCLAVE ROAD
SAKET NEW DELHI
110017 |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 MUKUL KAPOOR |
MAX SMART SUPER SPECIALITY HOSPITAL |
OPERATION THEATRE, FIRST FLOOR,MAX SMART SUPER SPECIALITY HOSPITAL
SAKET
PRESS ENCLAVE ROAD
NEW DELHI 110017 New Delhi DELHI |
997188873
MUKUL.KAPOOR@MAXHEALTHCARE.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
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.asa 1-3
2.patients requiring general anesthesia with proseal laryngeal mask airway |
|
| ExclusionCriteria |
| Details |
1. Patients with anticipated difficult airway
2. Pulmonary disease
3. ASA 4 and ASA 5
4. Hypersensitivity to one or more medications
5. Previous thoracic surgeries
6. Pregnancy
7. BMI > 30
8. Patients at risk of gastric aspiration |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To determine whether ultrasound examination of SAD placement is comparable with conventional leakage test to determine need of reinsertion of Proseal SAD.
2.comparison of fiberoptic and ultrasound methods for confirmation of proseal SAD placement |
ONLY ONE TIME POINT AFTER INDUCTION OF ANAESTHESIA |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. Comparing the time duration required by each method to confirm Proseal SAD placement |
time required for leak test,ultrasound and fiberoptic examination will be noted |
|
|
Target Sample Size
|
Total Sample Size="80" Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "80"
Final Enrollment numbers achieved (India)="80" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
25/12/2018 |
| Date of Study Completion (India) |
22/04/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0" Months="3" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
All patients will undergo a complete pre-anesthetic evaluation and NPO for 6 hours. All patients will be administered general anesthesia for the procedure. A standardized protocol for induction and maintenance of anesthesia will be follow which would comprise of intravenous fentanyl (1-2mcg/kg) followed by propofol (1.5-2mg/kg) for induction. Airway will be secured by an appropriate size Proseal SAD following administration of a non-depolarizing muscle relaxant. Size 3 Proseal will be use for patients weighing 30-50 Kg, size 4 for patients weighing 40-70 Kgs and size 5 for patients weighing 70-100 Kg. Anesthesia will be maintained with desflurane in oxygen and nitrous oxide titrated to maintain FiO2 of 0.5 at all times.A non-depolarizing muscle relaxant will be administered for maintenance of neuromuscular blockade. Standard volume control ventilation settings will be used in both groups with tidal volume of 8ml/kg, to maintain minute ventilation of 100ml/kg and end-tidal carbon dioxide (EtCO2) between 30-40 mm Hg. Leak pressure test will be conducted in all cases receiving Proseal SAD and the leak pressure shall be recorded. Airway leak pressure is defined as “the airway pressure (PL) at which the leak was heard with fresh gas flow (FGF) at 3 L/min and adjustable pressure limiting (APL) valve closed gradually up to 40 cm H2Oâ€. After the leak test, ultrasound examination on front of neck will be done in three planes and scoring done using the Ultrasound score system as below: Plane Ultrasound examination Comments THT 2 cuff shadows symmetrical/asymmetrical TLS Edge of the cuff tip and the shape of the cuff distorted and irregular/ smooth and regular PPL visualize the cuff tip and esophagus in the same plane by adjusting transducer Possible/ impossible THT = transverse plane between hyoid bone and thyroid bone; TLS =transverse plane of lateral suprasternal notch; PPL = parasagittal plane of pharynx and larynx. Fiberoptic examination will be done through Proseal SAD to confirm the position of SAD. The fiberoptic endoscope will be typically positioned just proximal to the end of the ventilator conduit, and then an attempt will be made to advance it under the epiglottis to see the vocal cords. Optimal placement is when the tip of the Proseal lying behind the arytenoids with a visible epiglottis, with no folding or intrusion into the airway, and with the vocal cords visible when the fiberscope advanced under the epiglottis.All other situations will be considered suboptimal placement. Fiberoptic examination will be done in only those cases where leak test is positive. At the end of the procedure, neuromuscular blockade will be reversed and post extubation patient will be shifted to PACU for observation. |