| CTRI Number |
CTRI/2025/04/086040 [Registered on: 30/04/2025] Trial Registered Prospectively |
| Last Modified On: |
28/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of Changes in Breathing Tube Pressure During Laparoscopic Surgeries in Different Body Positions: Upright and Tilted Down and Lying Flat |
|
Scientific Title of Study
|
Comparison Of Endotracheal Cuff Pressure Changes During Laparoscopic Abdominal Surgeries In Head Up Versus Head Down Versus Supine Horizontal Position - 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 GANGIREDDY KRISHNA REDDY |
| Designation |
Junior Resident |
| Affiliation |
Varun Arjun Medical College and Rohilkhand Hospital |
| Address |
Department of Anesthesia
Varun Arjun Medical College and Rohilkhand Hospital Lucknow Road,Banthra,Shahjahanpur
Shahjahanpur
UTTAR PRADESH
242307
India |
| Phone |
8985054346 |
| Fax |
|
| Email |
doctorgkreddy@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Saurabh Mishra |
| Designation |
Professor |
| Affiliation |
Varun Arjun Medical College and Rohilkhand Hospital |
| Address |
Department of Anesthesia Varun Arjun Medical College and Rohilkhand Hospital Lucknow Road,Banthra,Shahjahanpur
Shahjahanpur
UTTAR PRADESH
242307
India |
| Phone |
9554070570 |
| Fax |
|
| Email |
drsmishra0712@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR Amit Kumar |
| Designation |
Assistant Professor |
| Affiliation |
Varun Arjun Medical College and Rohilkhand Hospital |
| Address |
Department of Anesthesia Varun Arjun Medical College and Rohilkhand Hospital Lucknow Road,Banthra,Shahjahanpur
Shahjahanpur
UTTAR PRADESH
242307
India |
| Phone |
8475941938 |
| Fax |
|
| Email |
amit.kmc1979@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room No 1004 Department of Anesthesia
Varun Arjun Medical College and Rohilkhand Hospital Lucknow Road,Banthra,Shahjahanpur,Uttar Pradesh ,India Pin Code 242307 |
|
|
Primary Sponsor
|
| Name |
Dr Gangireddy Krishna Reddy |
| Address |
Room No 1004 Department of Anesthesia
Varun Arjun Medical College and Rohilkhand Hospital Lucknow Road,Banthra,Shahjahanpur,Uttar Pradesh ,India Pin Code 242307 |
| Type of Sponsor |
Private 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 Gangireddy Krishna Reddy |
Rohilkhand Hospital ,Banthra ,Shahjahanpur |
Room No 1004 Department of Anesthesia
Varun Arjun Medical College and Rohilkhand Hospital Lucknow Road,Banthra,Shahjahanpur,Uttar Pradesh ,India Pin Code 242307
Shahjahanpur
UTTAR PRADESH |
8985054346
doctorgkreddy@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee,Varun Arjun Medical College ,Banthr a,Shahjahanpur,uttar Pradesh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 4||Measurement and Monitoring, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Adult patient from either gender aged between 18 to 50 years.
Patient scheduled for elective laparoscopic surgery requiring nitrous oxide anesthesia with endotracheal intubation and controlled ventilation.
ASA grade I/II. |
|
| ExclusionCriteria |
| Details |
Any contraindications to use of nitrous oxide.
Patient having laryngeal diseases and undergoing laryngeal surgeries
Patient with any type of airway diseases.
If more than one attempt in intubation patient will be excluded from study.
Patients with high risk of pulmonary complications.
Non willing Patients. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the effect of patient positioning on endotracheal cuff pressure dynamics during laparoscopic abdominal surgeries.
1) Head up (30 degree) with supine position
2) Head down (30 degree) with supine position
3) Supine horizontal position
To determine the frequency of cuff pressure adjustments required during surgery in each position. |
In 1 Year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To investigate the relationship between changes in intra-abdominal pressure and variations in endotracheal cuff pressure.
To evaluate the incidence of complications associated with inappropriate cuff pressure management, such as air leaks or excessive pressure on the tracheal mucosa.
To compare the maximum tracheal cuff pressures reached in patients positioned head- up versus head-down during the surgical procedure. |
In 1 year |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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)
|
30/05/2025 |
| 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="0"
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
|
This study explores how endotracheal cuff pressures change during laparoscopic abdominal surgeries in different patient positions—head-up, head-down, and supine. Factors such as pneumoperitoneum (CO2 inflation), changes in intrathoracic pressure, and nitrous oxide diffusion into the cuff can lead to increased intracuff pressure, potentially causing tracheal mucosal damage and post-intubation complications like sore throat and hoarseness. Since cuff pressures are not routinely monitored, understanding these changes is critical for optimizing patient safety. Proper cuff pressure management tailored to surgical positioning can minimize airway complications and enhance outcomes in laparoscopic surgeries |