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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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