| CTRI Number |
CTRI/2016/08/007184 [Registered on: 16/08/2016] Trial Registered Retrospectively |
| Last Modified On: |
29/06/2016 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Surgical/Anesthesia |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
USE OF ULTRASOUND TO ASSESS THE UPPER AIRWAY[TONGUE,THICKNESS INFRONT OF WINDPIPE],SIZE OF THE NECK FOR ROBOT ASSISTED SURGERIES IN STEEP HEAD DOWN POSITION |
|
Scientific Title of Study
|
ULTRASONOGRAPHIC ASSESSMENT OF AIRWAY CHANGES IN STEEP TRENDLENBERG POSITION IN
ROBOTIC SURGERIES |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Seran Kumar Reddy M |
| Designation |
Junior Resident |
| Affiliation |
PGIMER |
| Address |
Department of Anaesthesia and Intensive Care,Level-4,Nehru Block,PGIMER,Chandigarh-160012
Room No:555,Kairon block,Pgimer,sector-12,chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8872442229 |
| Fax |
|
| Email |
seranreddy.m@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Divya Jain |
| Designation |
Associate Professor |
| Affiliation |
PGIMER |
| Address |
Department of Anaesthesia and Intensive Care,Level-4,Nehru Block,PGIMER,Chandigarh-160012
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7087008020 |
| Fax |
|
| Email |
jaindivya77@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Seran Kumar Reddy M |
| Designation |
Junior Resident |
| Affiliation |
PGIMER |
| Address |
Department of Anaesthesia and Intensive Care,Level-4,Nehru Block,PGIMER,Chandigarh-160012
Room No:555,Kairon block,Pgimer,sector-12,chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8872442229 |
| Fax |
|
| Email |
seranreddy.m@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
PGIMER |
| Address |
Department of Anaesthesia and Intensive care,Level-4,Nehru Hospital,PGIMER,Chandigarh-160012 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| SERAN KUMAR REDDY MEKALA |
PGIMER |
Department of Anaesthesia and Intensive care,Level-4,Nehru Hospital,PGIMER,Chandigarh-160012
Chandigarh
CHANDIGARH |
8872442229
seranreddy.m@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee.PGIMER |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patients undergoing robotic assisted prostatectomy,robotic assisted cystectomy and robotic assisted VVF repair, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA I-II Patients
Posted for robotic surgeries under general anaesthesia in steep trendlenberg position
|
|
| ExclusionCriteria |
| Details |
Patients who had upper airway pathology
• cervical spine fractures
• MMP 4
• History of difficult laryngoscopy or intubation
• congestive heart failure
• Renal disease were excluded. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Anterior soft tissue neck thickness at the level of hyoid bone |
Baseline[preoperatively]
After extubation[Modified Aldrete score more than 18]
2 hours after surgery
6 hours after surgery
12 hours after surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Anterior soft tissue thickness at the level of vocal cords
2.Submandibular sonographic measurement of tongue thickness
3.Mallampati grading
4.Thyromental distance
5.Neck circumference
6.Association of these changes with duration of surgery |
Baseline[preoperatively]
After extubation[Modified Aldrete score more than 18]
2 hours after surgery
6 hours after surgery
12 hours after surgery |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
01/10/2015 |
| 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) |
Open to Recruitment |
|
Publication Details
|
Not applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
We will be assessing airway changes by ultrasound in patients undergoing robotic surgeries in steep trendlenberg position.Parameters assessed include anterior soft tissue neck thickness at the level of hyoid bone,vocal cords and also mallampati grading,neck circumference at various intervals. |