| CTRI Number |
CTRI/2024/05/066778 [Registered on: 03/05/2024] Trial Registered Prospectively |
| Last Modified On: |
02/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
COMPARING HOW ENDOTRACHEAL TUBE CUFF PRESSURE CHANGES IN DIFFERENT POSITIONS DURING LAPAROSCOPICALLY PERFORMED ABDOMINAL SURGERIES |
|
Scientific Title of Study
|
Comparison of change in endotracheal tube cuff pressure during laparoscopic abdominal surgeries in different positions : An 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 SARITA JANWEJA |
| Designation |
Senior Professor |
| Affiliation |
DR. SN MEDICAL COLLEGE |
| Address |
DR. SN MEDICAL COLLEGE
Department of Anaesthesiology
Sector D, Shastri nagar, JODHPUR
Rajasthan
342003
India
Jodhpur
RAJASTHAN
342003
India |
| Phone |
9829116420 |
| Fax |
|
| Email |
Sarita.janweja@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR POORVI JAIN |
| Designation |
PG student |
| Affiliation |
DR. SN MEDICAL COLLEGE |
| Address |
DR. SN MEDICAL COLLEGE
Department of Anaesthesiology
Sector D, Shastri nagar,Jodhpur
Jodhpur
RAJASTHAN
342003
India
Jodhpur
RAJASTHAN
342003
India |
| Phone |
9829471272 |
| Fax |
|
| Email |
poorvij96@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR POORVI JAIN |
| Designation |
PG student |
| Affiliation |
DR. SN MEDICAL COLLEGE |
| Address |
DR. SN MEDICAL COLLEGE
Department of Anaesthesiology
Sector D, Shastri nagar,Jodhpur
Jodhpur
RAJASTHAN
342003
India
Jodhpur
RAJASTHAN
342003
India |
| Phone |
9829471272 |
| Fax |
|
| Email |
poorvij96@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. SN MEDICAL COLLEGE, Department of Anaesthesiology, Sector-D, Shastri nagar, Jodhpur, Rajasthan
Pincode- 342003 |
|
|
Primary Sponsor
|
| Name |
Dr. SN Medical College, Jodhpur |
| Address |
Residency Rd, Sector-D, Shastri Nagar, Jodhpur, Rajasthan 342003 |
| 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 Poorvi Jain |
MDM Hospital |
Department of Anaesthesiology, Main OT , Near Central Laboratory, Sector-H, Shastri Nagar
Jodhpur
RAJASTHAN |
9829471272
poorvij96@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DR SNMC INSTITUTIONAL ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K800||Calculus of gallbladder with acutecholecystitis, (2) ICD-10 Condition: N979||Female infertility, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients of ASA grade 1 and 2 posted for elective laparoscopic surgeries of duration less than 3 hours |
|
| ExclusionCriteria |
| Details |
Patients with history of recent respiratory tract infection, chronic smoker, airway disease, history of previous surgery involving airway, head and neck, more than one attempt of traumatic intubation, pregnant female |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To measure the endotracheal tube cuff pressure changes from the baseline values in head up and head down positions in laparoscopic surgeries |
Before carbon dioxide insufflation and desufflation and at the end of surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To measure the incidence of sore throat and hoarseness postoperatively. |
24 hours post surgery |
|
|
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)
|
14/05/2024 |
| 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="0"
Months="9"
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
|
There is an inadvertent increase in endotracheal tube cuff pressure following laparoscopic surgeries and the increase is especially more in laparoscopic surgeries involving a head up position. Hence intraoperative monitoring of endotracheal tube cuff pressures is must to prevent postoperative complications like sore throat and hoarseness especially in laparoscopic surgeries. |