| CTRI Number |
CTRI/2025/03/083514 [Registered on: 26/03/2025] Trial Registered Prospectively |
| Last Modified On: |
19/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Medical device |
| Study Design |
Other |
|
Public Title of Study
|
Evaluation of efficacy in early detection of apnoea and airway suctioning using a novel capnosuction mask |
|
Scientific Title of Study
|
Evaluation of efficacy in detection of apnoea and airway suctioning using a novel capnosuction mask in adults scheduled for elective surgeries under sedation - An observational feasible 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 |
Shanthi S |
| Designation |
Post graduate ( Junior resident) |
| Affiliation |
Saveetha medical college and hospital |
| Address |
Saveetha medical college and hospitals, Saveetha nagar, Thandalam , Bengaluru NH 48, Kancheepuram .
Kancheepuram TAMIL NADU 602105 India |
| Phone |
8939630762 |
| Fax |
|
| Email |
shanthi.saminathan1997@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Girimurugan N |
| Designation |
Associate professor |
| Affiliation |
Saveetha medical college and hospital |
| Address |
Saveetha medical college and hospital, Saveetha nagar, Thandalam , Bengaluru NH 48 , Chennai.
Kancheepuram TAMIL NADU 602105 India |
| Phone |
9840469518 |
| Fax |
|
| Email |
drgirimurugan@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Girimurugan N |
| Designation |
Associate professor |
| Affiliation |
Saveetha medical college and hospital |
| Address |
Saveetha medical college and hospital, Saveetha nagar, Thandalam , Bengaluru NH 48 , Chennai.
Kancheepuram TAMIL NADU 602105 India |
| Phone |
9840469518 |
| Fax |
|
| Email |
drgirimurugan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Saveetha medical college and hospital,Tamil nadu-602105, India |
|
|
Primary Sponsor
|
| Name |
Saveetha medical college and hospital |
| Address |
Saveetha medical and hospital,Saveetha nagar, Thandalam , Bengaluru NH 48 , Chennai, Tamil Nadu 602105 |
| 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 Shanthi S |
Saveetha medical college and hospital |
Saveetha medical college and hospital, Saveetha nagar, Thandalam , Bengaluru NH 48 , Chennai-602105 Kancheepuram TAMIL NADU |
8939630762
shanthi.saminathan1997@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: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Capnosuction mask |
Capnosuction masks improve EtCOâ‚‚ measurement accuracy by collecting COâ‚‚ nasally and orally, while also providing oxygen and suctioning to maintain airway patency. Capnography operates by infrared light absorption: COâ‚‚ in the sampling chamber absorbs infrared, with higher COâ‚‚ levels absorbing more light and resulting in lower detector readings. The process requires an infrared source, a sampling chamber, and a detector. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient undergoing elective surgeries under sedation
(TIVA)
2.ASA I / 2 |
|
| ExclusionCriteria |
| Details |
1.ASA3/4/5
2.allergy to narcotic and recent drug allergy
3.difficult airway |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
Early detection of apnoea - breathing cessation for more than 15 secs
|
Clinically detected apnea, oxygen desaturation and hypoxemia prompted an intervention that consisted of patient stimulation, withholding medication, a chin lift or jaw thrust maneuver, or increasing oxygen supplementation . |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Airway suctioning when required |
Patient secretions were cleared through the secretion port to maintain airway patency.
|
|
|
Target Sample Size
|
Total Sample Size="50" Sample Size from India="50"
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)
|
20/05/2025 |
| 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="2" 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
|
Patients were assessed in the sitting position for airway parameters before being positioned supine. Vital signs, including blood pressure (BP), oxygen saturation (SaOâ‚‚), and heart rate, were recorded prior to sedation. All patients undergoing sedation were connected to a CAPNOSUCTION mask before administering sedatives.
Sedation Protocol: An initial intravenous dose of 1 mg midazolam ,loading dose of dexmedetomidine 0.5-1mcg/kg over 20mins was followed by 1% propofol adjusted to body weight, age, and comorbidities (40 mg for <70 kg, 60 mg for ≥70 kg, or 20 mg for elderly or comorbid patients). Additional 10–20 mg doses of propofol were administered as needed.
Monitoring: Patients were continuously monitored for respiratory and cardiovascular parameters. Heart rate, pulse oximetry, and ECG changes were assessed, while BP was checked every 5 minutes. Capnography provided real-time assessments of ventilatory function via CO₂ waveforms and partial pressure (mmHg). Apnea was defined as exhaled CO₂ <8 mmHg for ≥15 seconds. Interventions for apnea or complications like oxygen desaturation (SaO₂ ≥5% below baseline), hypoxemia (SaO₂ <90%), hypotension (systolic BP <90 mmHg), or bradycardia (<50 bpm) included patient stimulation, withholding sedatives, airway maneuvers, or increased oxygen. Secretions were cleared through the mask’s secretion port.
After the procedure, monitoring was discontinued once patients responded verbally and vital signs stabilized. They were then transferred to recovery. |