| CTRI Number |
CTRI/2025/08/092806 [Registered on: 11/08/2025] Trial Registered Prospectively |
| Last Modified On: |
09/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Surgical/Anesthesia |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
A study to estimate the exhaled carbon dioxide while simultaneously delivering oxygen using a novel adapter for the Hudson Oxygen mask versus two commercially available carbon dioxide monitoring systems in patients who are spontanously breathing. |
|
Scientific Title of Study
|
Estimation of End tidal carbon dioxide using the Novel 3D printed reusable Dual EtCO2 - O2 universal adapter for Hudson mask versus two commercially available EtCO2 monitoring systems in spontaneously breathing patients: A prospective comparative crossover 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 Deepashri Marieta P J |
| Designation |
Postgraduate MD Anaesthesiology |
| Affiliation |
Saveetha Medical College and Hospital, SIMATS, Chennai |
| Address |
2nd floor, Department of Anaesthesiology, Saveetha Medical College and Hospital, SIMATS, Saveetha Nagar, Thandalam, Chennai 602105.
Chennai
TAMIL NADU
602105
India |
| Phone |
9840759914 |
| Fax |
|
| Email |
deepashrimarieta@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Yachendra V S G |
| Designation |
Professor Anaesthesiology |
| Affiliation |
Saveetha Medical College and Hospital, SIMATS, Chennai |
| Address |
2nf floor, Department of Anaesthesiology, Saveetha Medical College and Hospital, SIMATS, Saveetha Nagar, Thandalam, Chennai 602105.
Chennai
TAMIL NADU
602105
India |
| Phone |
9790963362 |
| Fax |
|
| Email |
dr_yach@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr Yachendra V S G |
| Designation |
Professor Anaesthesiology |
| Affiliation |
Saveetha Medical College and Hospital, SIMATS, Chennai |
| Address |
2nd floor, Department of Anaesthesiology, Saveetha Medical College and Hospital, SIMATS, Saveetha Nagar, Thandalam, Chennai 602105.
Chennai
TAMIL NADU
602105
India |
| Phone |
9790963362 |
| Fax |
|
| Email |
dr_yach@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Saveetha Medical College and Hospital, SIMATS, Chennai |
|
|
Primary Sponsor
|
| Name |
Dr Deepashri Marieta P J |
| Address |
Saveetha Medical College and Hospital, SIMATS, Saveetha Nagar, Thandalam, Chennai 602105 |
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Prof Dr Yachendra V S G |
Saveetha Medical College and Hospital, SIMATS, Saveetha Nagar, Thandalam, Chennai 602105 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Deepashri Marieta P J |
Saveetha Medical College and Hospital |
2nd floor OT complex, Department of Anaesthesiology, Saveetha Nagar, Thandalam, Chennai 602105
Chennai
TAMIL NADU |
9840759914
deepashrimarieta@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Saveetha Medical College and Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 4||Measurement and Monitoring, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Arterial blood gas analysis |
To compare the PaCO2 in arterial blood with the EtCO2 recorded using the novel adapter. |
| Intervention |
Novel Dual EtCO2 O2 universal adapter for the Hudson oxygen mask |
To monitor the end tidal carbon dioxide while simultaneously supplementing oxygen using the novel adapter. |
| Comparator Agent |
Sentri EtCO2 monitoring nasal cannula |
To monitor the End tidal carbon dioxide using the Sentri nasal cannula in comparison to that of the novel adapter. |
| Comparator Agent |
Sumi HiCapno mask kit |
To monitor the End tidal carbon dioxide using Sumi HiCapno mask kit in comparison to that of the novel adapter. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients aged 18 to 50 years, ASA 1 and ASA 2 patients, posted for elective surgery under regional anaesthesia |
|
| ExclusionCriteria |
| Details |
Surgeries lasting for less than one hour, Patients who were not willing to take part in the study, Active upper respiratory tract infection, COPD, Chronic smokers, Bronchial asthma, Obstructive sleep apnea, Obesity, Hypotension, shock, hemodynamic instability, hypovolemia, sepsis, Hypothermia, Need for intubation, Intraoperative opioid usage
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To validate our Novel 3D Printed Dual EtCO2 O2 Universal Adapter for Hudson mask by comparing it with two other commercially available EtCO2 monitoring systems and arterial PaCO2. |
The EtCO2 (end tidal carbon dioxide) is recorded with the Novel adapter first at every 2 minute interval over 10 minutes. The mean value is calculated from the 5 recordings of EtCO2 obtained over 10 minutes. The same process is repeated using the two commercially available devices. Oxygen is supplemented at 5 litres per minute in all devices. Arterial PaCO2 is also measured. The time taken to complete the entire test on each patient is estimated to be 45 minutes. |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
28/08/2025 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
-
End tidal carbon dioxide is the level of carbon dioxide that is released at the end of an exhaled breath. It is an indispensable tool of perioperative monitoring which has given valuable insight into the adequacy of ventilation and perfusion. So much so that the ASA has made it a part of the minimum monitoring standards for all patients under anaesthesia or sedation. Spontaneously breathing patients who require sedation are frequently given supplementary oxygen via a simple Hudson mask. As sedation causes respiratory depression leading to hypoxemia and hypercarbia capnographic monitoring becomes mandatory. However Hudson masks do not have the provision to monitor end tidal CO2. Towards this we have designed a simple reusable adapter for the Hudson mask which allows us to monitor End tidal CO2 without interrupting the supplemental oxygen flow thus enhancing safety while keeping costs low. Our study plans to validate our Novel 3D Printed Dual EtCO2 O2 Universal Adapter by comparing it with two other commercially available EtCO2 monitoring systems and arterial PaCO2. |