| CTRI Number |
CTRI/2018/03/012360 [Registered on: 06/03/2018] Trial Registered Retrospectively |
| Last Modified On: |
23/05/2012 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Development and evaluation of a breathing system to maintain carbondioxide level in the body for radiological investigation |
|
Scientific Title of Study
|
Development and evaluation of a MRI compatible non- rebreathing sequential gas delivery circuit to maintain constant end tidal Carbon dioxide (ETCO2), to be used for Cerebro Vascular Reactivity (CVR) assessment using fMRI and allied techniques. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr P Gayatri |
| Designation |
Additional Professor, Anesthesia |
| Affiliation |
Sree Chitra Tirunal Institute for Medical Sciences and Technology |
| Address |
Room 3110, 1st Floor,Dept of anesthesiology, Sree Chitra Tirunal Institute for Medical Sciences and Technology, Trivandrum.
Same as above
Thiruvananthapuram
KERALA
695011
India |
| Phone |
|
| Fax |
|
| Email |
gayat@sctimst.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bejoy Thomas |
| Designation |
Additional Professor, IS & IR |
| Affiliation |
Sree Chitra Tirunal Institute for Medical Sciences and Technology |
| Address |
Room 3112, 1st Floor,Dept of Imaging sciences & Interventional Radiology, Sree Chitra Tirunal Institute for Medical Sciences and Technology, Trivandrum.
Same as above
Thiruvananthapuram
KERALA
695011
India |
| Phone |
|
| Fax |
|
| Email |
bejoy@sctimst.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr P Gayatri |
| Designation |
Additional Professor, Anesthesia |
| Affiliation |
Sree Chitra Tirunal Institute for Medical Sciences and Technology |
| Address |
Room 3110, 1st Floor,Dept of anesthesiology, Sree Chitra Tirunal Institute for Medical Sciences and Technology, Trivandrum.
Same as above
Thiruvananthapuram
KERALA
695011
India |
| Phone |
|
| Fax |
|
| Email |
gayat@sctimst.ac.in |
|
|
Source of Monetary or Material Support
|
| Institute Internal Funding, Sree Chitra Tirunal Institute for Medical Sciences & Technology, Thiruvananthapuram, India |
|
|
Primary Sponsor
|
| Name |
SCTIMST |
| Address |
Sree Chitra Tirunal Institute for Medical Sciences and Technology, Trivandrum |
| 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 P Gayatri |
SCTIMST |
Room 3112, 1St floor, Anesthesiology department, Sree Chitra Tirunal Institute for Medical Sciences & Technology, Trivandrum
Thiruvananthapuram
KERALA |
09388012974
gayat@sctimst.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Sree Chitra Tirunal Institute for Medical Sciences & Technology, Trivandrum |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
healthy volunteers with no cardiac or respiratory or neurological co morbidities |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Sequential gas delivery circuit |
10% carbondioxide is introduced after the baseline values are obtained. The change in carbondioxide level after breathing 10% carbondioxide is compared with the baseline value. The same person acts as both intervention and comparator. |
| Intervention |
Sequential gas delivery circuit |
Apply on the face and breath normally. A set of baseline carbondioxide value is obtained. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Healthy adult humans in 20-50 years of age |
|
| ExclusionCriteria |
| Details |
Exclusion: Smokers, persons with cardiovascular and respiratory illness such as COPD, asthma, valvular and ischemic heart disease
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Sustained rise in end tidal carbondioxide for the desired duration |
after introduction of reserve gas flow |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Rise in arterial carbondioxide. |
At the same time as the rise in endtidal carbondioxide |
|
|
Target Sample Size
|
Total Sample Size="15"
Sample Size from India="15"
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)
|
25/04/2012 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The circuit will be tested first outside the MR environment and later in the MRI suite.
Healthy volunteers will be connected to peripheral oxygen saturation monitor and ETCO2 monitor. The ETCO2 will be continuously monitored from a sample at the nose. The baseline blood pressure will be obtained and then at 5 minute intervals.
The volunteers will breathe a fresh gas flow (FGF) consisting of oxygen and air with this SGD through a mouth piece and a well fitting face mask.
The FGF of oxygen in air through the unidirectional valve will be adjusted in such a way that the reservoir bag collapses at the end of each inspiration. This will be noted as the minute ventilation. The fresh gas flow will be further reduced and ETCO2 will be noted. The FGF at which the ETCO2 rises will be noted as the alveolar ventilation.
The inspired CO2 will be altered and ETCO2 will be observed. The optimum FGF required to maintain a constant ETCO2 will be assessed. Further to find out if this ETCO2 correlates with the PaCO2, arterial blood gas will be analysed in the first five volunteers.
Once standardisation of the circuit is completed, fMRI study to test CVR will be performed using the device in the next ten volunteers. Standard EPI fMRI sequences will be adapted for the CVR study and the data analysis methods for CVR will also be developed.
For the Cerebro- Vascular Reactivity (CVR) study, we need to vary the Pa CO2 level from approximately 35 to 50 mm of Hg in short cycles of 1-2 minutes for a total of 6 cycles. Planning to study such 2 runs, for each volunteer. The total time for MRI study would be approximately 30-40 minutes including anatomic scans.
There is no risk to the volunteer from breathing 10% carbondioxide (CO2). Carbondioxide has been used safely in many studies previously without any adverse effects from its use in concentrations as high as 40% (1).
Carbondioxide is a physiological gas.The maximum level of inspired carbondioxide during the study period will be kept well within physiological levels of CO2 (2). We will make sure the inspiratory carbon dioxide level will not exceed 7 %. Therefore the maximum carbon dioxide level that will be obtained in the body will be 50 mm Hg. The inspiratory carbondioxide level will be continuously monitored and adjusted. In the rare event that the subject should breathe 10% carbon dioxide, which is the maximum level of inspiratory carbon dioxide possible from this circuit, it would still result in 68 mm Hg carbon dioxide in the blood, which is the level of permissive hypercapnia (3), i.e. the maximum allowable level of carbon dioxide in the body during disease states such as acute respiratory distress syndrome.
For the Cerebro- Vascular Reactivity (CVR) study, we need to vary the Pa CO2 level from approximately 35 to 50 mm of Hg in short cycles of 1-2 minutes for a total of 6 cycles. Planning to study such 2 runs, for each volunteer. The total time for MRI study would be approximately 30-40 minutes including anatomic scans.
The carbon dioxide level in the cylinder will be tested before being used on the first volunteer.
The oxygen levels could go down during the study if there is any malfunction of the parts of the circuit for eg. Sticky valves which can lead to hypoxemia.
fMRI is a safe study in normal healthy volunteers with no contraindications for MR imaging.
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