| CTRI Number |
CTRI/2025/02/081267 [Registered on: 25/02/2025] Trial Registered Prospectively |
| Last Modified On: |
22/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study to assess role of Transnasal Humidified Rapid Insufflation Ventilatory Exchange in Endoscopic Retrograde Cholangiopancreatography |
|
Scientific Title of Study
|
An Observational study to assess role of Transnasal Humidified Rapid Insufflation Ventilatory Exchange with Target Controlled Infusion as sole airway management during Endoscopic Retrograde Cholangiopancreatography |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ilancheran J |
| Designation |
Post Graduate |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Department of Anaesthesiology,Sri Ramachandra Institute of Higher
Education and Research,No 1,Mount Poonamallee
Road,Porur,Chennai,
Chennai
Chennai
TAMIL NADU
600116
India |
| Phone |
919500123649 |
| Fax |
|
| Email |
ilancheranman@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Aruna Parameswari |
| Designation |
Professor and Head of Department |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Department of Anaesthesiology,Sri Ramachandra Institute of Higher
Education and Research,No 1,Mount Poonamallee
Road,Porur,Chennai,
Chennai
Chennai
TAMIL NADU
600116
India |
| Phone |
9840529863 |
| Fax |
|
| Email |
reetharun@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Aruna Parameswari |
| Designation |
Professor and Head of Department |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Department of Anaesthesiology,Sri Ramachandra Institute of Higher
Education and Research,No 1,Mount Poonamallee
Road,Porur,Chennai,
Chennai
Chennai
TAMIL NADU
600116
India |
| Phone |
9840529863 |
| Fax |
|
| Email |
reetharun@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Ramachandra Institute of Higher
Education and Research,No 1,Mount Poonamallee
Road,Porur,Chennai,
Chennai
TAMIL NADU
600116
India-No additional costs. |
|
|
Primary Sponsor
|
| Name |
Dr Ilancheran J |
| Address |
Department of Anaesthesiology , Sri Ramachandra Institute of
Higher Education and Research , No 1, Mount Poonamallee
road,Porur, Chennai, Tamil Nadu-600116 |
| Type of Sponsor |
Other [Self] |
|
|
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 Ilancheran J |
Sri Ramachandra Institute of Higher Education and Research |
F-1 OR Complex,First floor, Udayar block ,Sri Ramachandra Institute of Higher
Education and Research,No 1,Mount Poonamallee
Road,Porur,Chennai,
Chennai
Chennai
TAMIL NADU |
9500123649
ilancheranman@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Research Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K801||Calculus of gallbladder with othercholecystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Transnasal humidified rapid insufflation ventilatory exchange with target controlled infusion as sole airway management during endoscopic retrograde cholangiopancreatography |
Transnasal humidified rapid insufflation ventilatory exchange is used as the sole airway management with target controlled infusion of propofol instead of conventional endotracheal intubation.Eleveld model of Target controlled infusion that follows a pharmacokinetic-pharmodynamic model is used.Initial standard effect site concentration of 0.5mcgs/ml of propofol is set and titrated according to the Bispectral Index value.The total duration of intervention is till the procedure is complete.Pre and post procedural arterial blood gas analysis is noted. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Body mass index less than 40kg/m2
American Society of Anaesthesiologists(ASA 1-3) |
|
| ExclusionCriteria |
| Details |
Patients younger than 18 years of age
Anticipated difficult airway.
P a r t u r i e n t
Risk of aspiration
Hemodynamic instability
Heart disease
Emergency surgeries
Allergy to propofol
Patient refusal
Inability to give consent to the study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the number of episodes of desaturation and duration of desaturation |
Intraoperative ( Beginning to end of procedure) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Total Propofol used
End Tidal Co2
Arterial Blood Gas at the beginning & end of procedure
Need for rescue
ventilation
Time taken to respond to oral commands
Incidence of sore throat or
dryness
Hemodynamics at thrive removal Patient satisfaction |
Intraoperative ( Beginning to end of procedure) |
|
|
Target Sample Size
|
Total Sample Size="56"
Sample Size from India="56"
Final Enrollment numbers achieved (Total)= "56"
Final Enrollment numbers achieved (India)="56" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
21/03/2025 |
| Date of Study Completion (India) |
01/07/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Patients fulfilling the inclusion criteria are selected.The appropriate details are filled in the proforma and consent obtained. The primary objective is to assess the number of episodes of desaturation and duration of desaturation.The secondary outcomes would be to assess the total propofol used, end tidal co2, arterial blood gas at the beginning & end of procedure, need for rescue ventilation, time taken to respond to oral commands, incidence of sore throat or dryness, hemodynamics at thrive removal, patient satisfaction and results are withdrawn. |