| CTRI Number |
CTRI/2019/05/018906 [Registered on: 02/05/2019] Trial Registered Prospectively |
| Last Modified On: |
20/04/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
To study the changes in the endotracheal tube cuff pressure during abdominal surgery. |
|
Scientific Title of Study
|
To study the changes in endotracheal tube cuff pressure during abdominal surgery, with or without pneumoperitoneum. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nagarapu Divya Meghana |
| Designation |
Primary DNB First year , Anaesthesia |
| Affiliation |
Rajiv Gandhi Cancer Institute |
| Address |
Dept of anaesthesia, Rajiv Gandhi Cancer Institute, Rohini institutional area, sector 5,New Delhi, Delhi.
North West
DELHI
110085
India |
| Phone |
7981017162 |
| Fax |
|
| Email |
ndmeghana@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manoj Bharadwaj |
| Designation |
Consultant, Department of anaesthesia. |
| Affiliation |
Rajiv Gandhi Cancer Institute |
| Address |
Rajiv Gandhi Cancer Institute, Rohini institutional area, sector 5,New D elhi, Delhi.
North West
DELHI
110085
India |
| Phone |
9968604220 |
| Fax |
|
| Email |
manojb8@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Nagarapu Divya Meghana |
| Designation |
Primary DNB First year , Anaesthesia |
| Affiliation |
Rajiv Gandhi Cancer Institute |
| Address |
Department of anaesthesia,Rajiv Gandhi Cancer Institute, Rohini institutional area,sector5,New Delhi, Delhi.
Sec25,Rohini
124,Pocket 1
North West
DELHI
110085
India |
| Phone |
7981017162 |
| Fax |
|
| Email |
ndmeghana@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Finance; Rajiv Gandhi Cancer Institute & Research Center, Sec 5, Near Rohini
West Metro Station, Rohini, New Delhi - 110085
|
|
|
Primary Sponsor
|
| Name |
Rajiv Gandhi Cancer Institute And Research Center |
| Address |
Rajiv Gandhi Cancer Institute, Rohini institutional area,sector5,New Delhi,Delhi. |
| 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 |
| Dr Divya meghana |
Rajiv Gandhi Cancer Institute |
Operation Theatre,
Third Floor, Old
Building Division;
Department of
Anesthesiology; Rajiv
Gandhi Cancer Institute
and Research Centre,
Sec 5, Rohini, New
Delhi 110085
North West,Delhi.
North West
DELHI |
7981017162
ndmeghana@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL REVIEW BOARD |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C61||Malignant neoplasm of prostate, (2) ICD-10 Condition: C569||Malignant neoplasm of unspecifiedovary, (3) ICD-10 Condition: C55||Malignant neoplasm of uterus, partunspecified, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
ASA GRADE I & II.
DURATION OF SURGERY MORE THAN 2 HOURS.
ABDOMINAL SURGERY REQUIRING LITHOTOMY POSITION. |
|
| ExclusionCriteria |
| Details |
ASA Grade III & IV.
Respiratory disorders.
N2O Administration.
Ascites. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in endotracheal tube cuff pressure during abdominal surgery with pneumoperitoneum. |
T0 After intubation,T1 Before lithotomy, T2 After lithotomy, T3 Before pneumoperitoneum, T4 Just after pneumoperitoneum,T5 5minutes after pneumoperitoneum, T6a 30mins, T6b 60mins, T6C 90mins, T6d 120mins, T6e 150mins,T6f 180mins,T7 Before the release of pneumoperitoneum, T8 After the release of pneumoperitoneum, T9 Supine position, T10 Before extubation. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Changes in endotracheal tube cuff pressure during open abdominal surgery. |
T0 After intubation,T1 Before lithotomy, T2 After lithotomy, T3 Before incision, T4 Just after incision,T5 5minutes after incision, T6a 30mins, T6b 60mins, T6C 90mins, T6d 120mins, T6e 150mins,T6f 180mins,T7 Before the closure, T8 After the closure, T9 Supine position, T10 Before extubation. |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
Final Enrollment numbers achieved (Total)= "120"
Final Enrollment numbers achieved (India)="120" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/05/2019 |
| Date of Study Completion (India) |
20/07/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
20/07/2020 |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
NONE YET |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
This is a hospital-based, prospective, observational, cohort study comparing the changes in the endotracheal tube cuff pressure in 60 cases of abdominal surgeries requiring pneumoperitoneum with 60 cases of open abdominal surgeries. Our primary objective is to study how pneumoperitoneum effects endotracheal tube cuff pressure and secondary objective is to correlate the changes in endotracheal tube cuff pressure with BMI and airway pressure, at different different time points during the surgery. |