| CTRI Number |
CTRI/2024/11/076983 [Registered on: 19/11/2024] Trial Registered Prospectively |
| Last Modified On: |
08/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
THE AIM OF THE STUDY IS TO SEE IF THE LOW VOLUME OF AIR FOR INFLATION OF ENDOTRACHEAL TUBE CUFF USING PRESSURE VOLUME LOOP SPIROMETRY TECHNIQUE IS SUFFICIENT TO AVOID A LEAK AROUND THE CUFF DURING VENTILATION IN LAPAROSCOPIC SURGERY PATIENTS. |
|
Scientific Title of Study
|
A Study To Establish The Efficacy Of Pressure Volume Loop Spirometry Technique For Endotracheal Tube Cuff Inflation For Patients Posted For Laparoscopic Surgeries Under General Anaesthesia. |
| 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 Priyaadharshini T |
| Designation |
DNB ANAESTHESIOLOGY |
| Affiliation |
|
| Address |
Sri Narayani Hospital And Research Centre, Thirumalaikodi, Sripuram, Vellore, Tamilnadu. 632055
Sri Narayani Hospital And Research Centre, Thirumalaikodi, Sripuram, Vellore, Tamilnadu. 632055
Vellore
TAMIL NADU
632055
India |
| Phone |
9787904871 |
| Fax |
|
| Email |
madhutspr1996@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR Kiran Kuruvilla George |
| Designation |
MD , FIPM Consultant Anaesthesiology |
| Affiliation |
|
| Address |
Sri Narayani Hospital And Research Centre, Thirumalaikodi, Sripuram, Vellore, Tamilnadu. 632055
Vellore
TAMIL NADU
632055
India |
| Phone |
9626888412 |
| Fax |
|
| Email |
kirangeorge_k2g@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Priyaadharshini T |
| Designation |
DNB ANAESTHESIOLOGY |
| Affiliation |
|
| Address |
Sri Narayani Hospital And Research Centre, Thirumalaikodi, Sripuram, Vellore, Tamilnadu. 632055
Vellore
TAMIL NADU
632055
India |
| Phone |
9787904871 |
| Fax |
|
| Email |
madhutspr1996@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Narayani Hospital And Research Centre, Thirumalaikodi, Sripuram, Vellore, Tamilnadu, India.
632055 |
|
|
Primary Sponsor
|
| Name |
Dr Priyaadharshini T |
| Address |
Sri Narayani Hospital And Research Centre, Thirumalaikodi, Sripuram, Vellore, Tamilnadu. 632055 |
| 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 Priyaadharshini T |
Sri Narayani Hospital And Research Centre |
Operation Theatre , C and A Block, Department of Anaesthesiology.
Vellore
TAMIL NADU |
9787904871
madhutspr1996@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRI NARAYANI HOSPITAL AND RESEARCH CENTRE INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K87||Disorders of gallbladder, biliarytract and pancreas in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients undergoing elective laparoscopic surgeries
2. ASA 1,2,3
3. Age between 18 to 60 years
|
|
| ExclusionCriteria |
| Details |
1. If peak airway pressure exceeds 35cm H2O during CO2 insufflation of peritoneum to avoid barotrauma,
2. If the EtCO2 rise above 40mmHg,
3. H/o Asthma,
4. Chronic lung diseases,
5. Preoperative cough, sore throat , hoarseness of voice.
6. Difficult airway
7. Patient who refuse consent
8. Patients with full stomach , those who requires rapid sequence intubation.
9. Pregnant women
|
|
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Method of Generating Random Sequence
|
|
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Method of Concealment
|
|
|
Blinding/Masking
|
|
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Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate if any increase in ET tube cuff volume is warranted to avoid air leak around the cuff due to rise in peak inspiratory pressure after peritoneal CO2 insufflation for laparoscopic procedures under general anaesthesia by recording pressure volume loop spirometry curve on anaesthesia workstation. |
1.Immediately after Intubation 2. After initiation of pneumoperitoneum of abdomen with carbondioxide during laparoscopic surgery. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study the incidence of cuff related complications such as sore throat, cough / hoarseness of voice post extubation. |
After Extubation
At 2 hours
At 24 hours |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
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)
|
16/12/2024 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
Modification(s)
|
Not yet done |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Endotracheal intubation is routinely performed during general anaesthesia. When the cuff on the ETT is inflated, it is crucial to maintain a proper cuff pressure because both high or low cuff pressure can lead to serious adverse events. Either overinflation causes ischaemic changes or underinflation of the cuff may lead to risk of aspiration. Pressure volume loop (PV-L) is a real time continuous pulmonary graph incorporated in anaesthesia workstation. It has been shown that Pressure volume loop (PV -L) provides adequate seal. The advantage of using PV -L than other methods is that it requires low volume of air & less cuff pressure compared to standard techniques of cuff inflation. Changes in respiratory parameters will be recorded during pre insufflation, following 2 mins of pneumoperitoneum with the help of PVL spirometry by evaluating the presence of air leak around the ETT cuff and to ensure that it provides adequate seal in patients undergoing for laparoscopic surgeries. |