| CTRI Number |
CTRI/2024/12/078749 [Registered on: 30/12/2024] Trial Registered Prospectively |
| Last Modified On: |
30/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Postoperative airway assessment using USG in Robotic surgeries |
|
Scientific Title of Study
|
Ultrasonographic evaluation of the postoperative airway edema following robotic gynecological and urological onco surgeries and its effect on extubation-A prospective observational study |
| 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 ARGHYA MUKHERJEE |
| Designation |
Senior Consultant ONCO ANESTHESIOLOGY,MEDICA SUPERSPECIALTY HOSPITAL |
| Affiliation |
Medica superspecialty Hospital |
| Address |
D BLOCK, ONCO OT, room number-2,
MEDICA SUPERSPECIALTY HOSPITAL,
127, EMBYPASS, MUKUNDPUR,KOLKATA-700099
127, EMBYPASS, MUKUNDPUR,KOLKATA-700099
Kolkata
WEST BENGAL
700099
India |
| Phone |
09830430936 |
| Fax |
|
| Email |
arghya.mukherjee547@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
SOUVIK CHOUDHURY |
| Designation |
FELLOW ONCO ANESTHESIOLOGY,MSHK |
| Affiliation |
Medica superspecialty Hospital |
| Address |
D BLOCK ONCO OT, room number-2
MEDICA SUPERSPECIALTY HOSPITAL, 127 EMBYPASS, MUKUNDPUR,KOLKATA-700099
127, EMBYPASS, MUKUNDPUR,KOLKATA-700099
Kolkata
WEST BENGAL
700099
India |
| Phone |
09434502998 |
| Fax |
|
| Email |
souvik86_bmc@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
SOUMYA JHA |
| Designation |
JUNIOR CONSULTANT ONCO ANESTHESIOLOGY MSHK |
| Affiliation |
Medica superspecialty Hospital |
| Address |
D BLOCK ONCO OT, room number-2, MEDICA SUPERSPECIALTY HOSPITAL
127 EMBYPASS, MUKUNDPUR,KOLKATA-700099
127, EMBYPASS, MUKUNDPUR,KOLKATA-700099
Kolkata
WEST BENGAL
700099
India |
| Phone |
8240874755 |
| Fax |
|
| Email |
jhasoumya6@gmail.com |
|
|
Source of Monetary or Material Support
|
| DEPARTMENT OF ONCOANESTHESIOLOGY,MEDICA SUPERSPECIALTY HOSPITAL, WESTBENGAL, KOLKATA-700015,INDIA
MEDICA SUPERSPECIALTY HOSPITAL |
|
|
Primary Sponsor
|
| Name |
NA |
| Address |
NA |
| Type of Sponsor |
Other [NO SPONSOR INVOLVED AS OBSERVATIONAL STUDY] |
|
|
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 SOUVIK CHOUDHURY |
MEDICA SUPER SPECIALTY HOSPITAL |
D BLOCK ,ONCO OT,
ROOM NUMBER-2
MEDICA SUPERSPECIALTY HOSPITAL,
127 EM BYPASS, MUKUNDPUR, KOLKATA-700099
Kolkata
WEST BENGAL |
09434502998
souvik86_bmc@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| CLINICAL RESEARCH ETHICS COMMITTE MEDICA SUPERSPECIALTY HOSPITAL KOLKATA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C51-C58||Malignant neoplasms of female genital organs, (2) ICD-10 Condition: C61||Malignant neoplasm of prostate, (3) ICD-10 Condition: C67||Malignant neoplasm of bladder, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
OBSERVATIONAL STUDY |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. ASA PS I, II, III
2. Age 18 years to 65 year
3. Patients scheduled to undergo elective surgeries under general anaesthesia with laryngoscopy and intubation
4. BMI less than 30Kg/sqm |
|
| ExclusionCriteria |
| Details |
1. Patient not willing to participate
2. ASA PS IV and above
3. Pregnant and lactating mothers
4. Patients with hepatic, renal and cardiopulmonary diseases
5. patients with cervical spine fracture
6. Anticipated difficult airway due to deformity, tumour or trauma
7. Patients who have contraindications for deep trendelenberg position
8. BMI more than 30Kg/sqm
9. Patients whose SBP is less than 100mmHg and DBP less than 60mmHG
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Perioperative airway edema by comparing preoperative and postoperative USG guided airway parameters. Parameters are tongue thickness, tongue volume, submental region thickness , lateral pharyngeal wall thickness and parapharyngeal wall thickness |
Perioperative airway edema by comparing preoperative and postoperative USG guided airway parameters. Parameters are tongue thickness, tongue volume, submental region thickness , lateral pharyngeal wall thickness and parapharyngeal wall thickness in preoperative period, prior to extubation and 30 minutes, 60 minutes and 90 minutes post extubation period. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine the extubation time in each case |
5 months |
| To observe any respiratory complication in each case |
5months |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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)
|
15/01/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
15/01/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="5"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Over a period of five months we will be observing preoperative and postoperative airway parameters of 64 patients posted for robotic gynaecological and urological onco surgeries using ultrasonography as a tool. We will also observe extubation time and respiratory complications if any for each case. Using this data we will assess the airway edema in these surgeries and its effect on patient outcome. |