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CTRI Number  CTRI/2025/05/087336 [Registered on: 21/05/2025] Trial Registered Prospectively
Last Modified On: 21/05/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Efficacy of a 3D-Printed Facemask With Detachable Nasal Cannula for Apneic Oxygenation During Intubation in Adult Patients 
Scientific Title of Study   A Prospective Randomised Controlled Study To Evaluate The Efficacy Of A Novel 3D Printed Facemask With An Integrated And Detachable Nasal Cannula For Providing Apneic Oxygenation By Assessing Arterial PartialPressure Of Oxygen During Larygoscopy And Intubation In Adult Patients Undergoing Surgical Procedures Under General Anaesthesia 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Aarthi 
Designation  MBBS Final Year MD Anaesthesiology  
Affiliation  Saveetha Medical College And Hospital 
Address  Saveetha Medical College And Hospital Anaesthesiology department Thandalam Bengaluru road NH4 Chennai
Saveetha Medical College And Hospital Anaesthesiology department Thandalam Bengaluru road NH4 Chennai 602105
Chennai
TAMIL NADU
602105
India 
Phone  7397551922  
Fax    
Email  arthichezhian0@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR YACHENDRA  
Designation  MD Anaesthesiology  
Affiliation  Saveetha Medical College And Hospital 
Address  Saveetha Medical College And Hospital Anaesthesiology department Thandalam Bengaluru road NH4 Chennai
Saveetha Medical College And Hospital Anaesthesiology department Thandalam Bengaluru road NH48 Chennai 602105
Chennai
TAMIL NADU
602105
India 
Phone  9790963362  
Fax    
Email  dr_yach@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Yachendra 
Designation  MD Anaesthesiology  
Affiliation  Saveetha Medical College And Hospital 
Address  Saveetha Medical College And Hospital Anaesthesiology department Thandalam Bengaluru road NH4 Chennai
Saveetha Medical College And Hospital Anaesthesiology department Thandalam Bengaluru road NH48 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 Saveetha nagar Thandalam Bangaluru road Chennai 602105 
 
Primary Sponsor  
Name  Saveetha Medical College And Hospital 
Address  Department Of Anaesthesiology Saveetha Medical College And Hospital Thandalam Bangaluru road NH48 Chennai 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 Aarthi  Saveetha Medical College And Hospital  Saveetha Medical college and Hospital Anaesthesiology department Saveetha nagar Thandalam Bengaluru road NH48 Chennai
Chennai
TAMIL NADU 		 7397551922

arthichezhian0@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Saveetha medical college and hospital Instructional ethic committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Posted for surgery 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  3D Printed Face Mask with Integrated and Detachable Nasal Cannula  The investigational device is a novel, low-cost 3D printed facemask incorporating an integrated and detachable nasal cannula designed to provide apneic oxygenation without interfering with mask ventilation. This facemask allows standard preoxygenation to be performed, after which the face mask is removed for laryngoscopy while the detachable nasal cannula remains in place to continue providing oxygen during the apneic phase. The detachable cannula design eliminates the need for separate nasal cannula placement, which often interferes with mask fit and seal. By integrating both functions (mask ventilation and apneic oxygenation), this device ensures uninterrupted oxygenation throughout the peri-intubation period. Oxygen is delivered via the cannula at a flow rate of 10-15 L/min from induction until successful intubation. This device may be particularly useful during anticipated or unanticipated difficult airway scenarios, and for teaching intubation to trainees, by prolonging safe apnoea time and reducing the risk of desaturation. 
Comparator Agent  Face mask with integrated nasal cannula  A conventional face mask with a separate nasal cannula delivering oxygen at 6 L/min during preoxygenation and apneic oxygenation.The conventional face mask and nasal cannula were used for 5 minutes of standardized preoxygenation, followed by continuous nasal oxygen delivery during the apneic period, which lasted until successful intubation or a maximum of 2 minutes. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Adult patients aged 18-50 years
Scheduled for elective surgery requiring general anesthesia
American Society of Anesthesiologists physical status classification I-III 
 
ExclusionCriteria 
Details  Patients with anticipated difficult mask ventilation
Nasal obstruction or recent nasal surgery.
Low oxygen saturation preoperatively
Pre-existing pulmonary diseases
Patient refusal to participate in the study 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The novel device will maintain higher PaO2 levels at the end of the apneic period compared to the conventional method, indicating better preservation of oxygen levels during the apneic phase.


 		 At baseline


 
 
Secondary Outcome  
Outcome  TimePoints 
We expect to prove that the novel device provides both good preoxygenation & apneic oxygenation with a single device.
The device will show a more effective reduction in PaCO2 levels during the apneic period than the conventional approach at baseline
 		 At baseline 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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   Phase 2 
Date of First Enrollment (India)   01/06/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  01/06/2025 
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 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  

Group A will undergo induction of anaesthesia with the novel 3D printed device 

Group B will undergo induction of anesthesia with the conventional face mask with a separately attached nasal cannula and tubing.

Patients are preoxygenated for a period of 5 minutes with 8 litres/min of oxygen with either the conventional face mask and a separate nasal cannula connected t an independent oxygen source at 8 liters/ min of oxygen or a 3D printed face mask as per the group allotted. Induction is then done with Inj.Glycopyrolate 0.2mg IV, Inj.Midazolam 2 mg IV, Inj. Fentanyl 2microgms/Kg IV and Inj.Propofol 2mg/kg IV. after confirming adequacy of mask ventilation the patient is administered Inj.Atracurium 0.5mg/kg IVand mask ventilation continued for 3 min. 

In group A the mask is removed while leaving the detachable nasal prongs in place to continue apneic oxygenation and laryngoscopy and intubation done. In group B conventional mask ventilation is done followed by laryngoscopy and intubationwhile leaving the nasal cannula in position for providing apneic oxygenation 

Arterial blood would be collected at two time points, immediately before laryngoscopy i.e. the start of apneic period and again after intubation before delivery of the first breath i.e at the end of apneic period. Time duration of apneic period is noted.

                    The primary objective will be determined by the PaO2levels in the arterial blood at the start and end of the apneic period showing the degree of drop in the partial pressure of oxygen in the blood which will go towards proving the ability of the device to maintain the partial pressure of oxygen levels much higher than the conventional method of preoxygenation. The ability of the oxygen flow maintained during the apneic period should also be enough to provide some decrease in PaCo2 levels which can be quantified by the arterial blood gas analysis and will form the secondary outcome of the study along with the ease of mask ventilation as assessed by the 5 point Likerts scale.

 
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