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CTRI Number  CTRI/2022/06/043612 [Registered on: 30/06/2022] Trial Registered Prospectively
Last Modified On: 29/06/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison of Stomach inflation during HFNC Oxygenation versus Regular Face Mask Ventilation prior to General Anaesthesia in adult patients. 
Scientific Title of Study   Comparison of Gastric insufflation during High Flow Nasal Cannula Oxygenation versus Conventional Face mask ventilation prior to Elective intubation in adults: a prospective randomised trial. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  A V SANDEEP KUMAR D 
Designation  Assistant professor 
Affiliation  Pondicherry Institute of Medical Sciences 
Address  Department of Anaesthesiology, Pondicherry Institute of Medical Sciences, Ganapathychettikulam, Puducherry

Pondicherry
PONDICHERRY
605014
India 
Phone  9963597008  
Fax    
Email  davsandeepk@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  A V SANDEEP KUMAR D 
Designation  Assistant professor 
Affiliation  Pondicherry Institute of Medical Sciences 
Address  Department of Anaesthesiology, Pondicherry Institute of Medical Sciences, Ganapathychettikulam, Puducherry

Pondicherry
PONDICHERRY
605014
India 
Phone  9963597008  
Fax    
Email  davsandeepk@gmail.com  
 
Details of Contact Person
Public Query
 
Name  A V SANDEEP KUMAR D 
Designation  Assistant professor 
Affiliation  Pondicherry Institute of Medical Sciences 
Address  Department of Anaesthesiology, Pondicherry Institute of Medical Sciences, Ganapathychettikulam, Puducherry

Pondicherry
PONDICHERRY
605014
India 
Phone  9963597008  
Fax    
Email  davsandeepk@gmail.com  
 
Source of Monetary or Material Support  
Pondicherry Institute of Medical Sciences 
 
Primary Sponsor  
Name  Pondicherry Institute of Medical Sciences 
Address  Dean Research, Pondicherry Institute of Medical Sciences, Ganapathychettikulam, Puducherry 605014 
Type of Sponsor  Private medical college 
 
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 A V Sandeep Kumar D  Pondicherry Institute of Medical Sciences  Department of Anaesthesiology, Pondicherry Institute of Medical Sciences, Ganapathychettikulam, Puducherry 605014
Pondicherry
PONDICHERRY 
9963597008

davsandeepk@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
PIMS INSTITUTE 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 
Comparator Agent  Conventional Face Mask preoxygenation and Ventilation  Patients will be preoxygenated with snuggly held facemask and a fresh gas flow of 10 litres/minute using 100% oxygen delivered via a circle system for 3 minutes prior to induction. After induction, oral airway will be secured, jaw thrust applied and volume controlled ventilation will be initiated at a tidal volume of 8ml/kg with a frequency of 12 breaths/minute using no PEEP untill intubation. Frequency: once for a patient Duration: 6-8 minutes 
Intervention  High Flow Nasal Cannula oxygenation  Patients will be connected to HFNC (Airvo 2) with initial flow of 40 litres/minute with heated and humidified 100% Oxygen and gradually flows will be increased to 70 litres/minute over one minute, along with jaw thrust after induction untill intubation. Frequency: once per patient Duration: 6-8 minutes 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Patients of American Society of Anaesthesiologists grade I, II and III.
2. Age group between 18 years and 60 years of both sexes and
3. Surgeries requiring general anaesthesia with elective intubation. 
 
ExclusionCriteria 
Details  1. Emergency surgeries.
2. BMI > 30 kg/m2.
3. ASA defined difficult airway.
4. Pregnancy.
5. Gastro-esophageal reflux disease.
6. Hiatal hernia.
7. Facial injuries.
8. Pulmnory comorbidities and
9. Cardiac comorbidities. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Gastric antral area measurement using ultrasound prior and after oxygenation before intubation in adults patients receiving General Anesthesia.  Baseline, 3 minutes and 6 minutes. 
 
Secondary Outcome  
Outcome  TimePoints 
a. increase in PaCO2 in ABG samples
b. desaturation ( 90%) during intubation and
c. haemodynamic changes during preoxygenation and intubation in
electively intubated patients. 
a. Baseline, 3 minutes and 6 minutes.
b. Baseline, 3 minute and 6 minute
c. Baseline, 3 minute and 6 minute 
 
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)   01/07/2022 
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="5"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Preoxygenation in adult anaesthesia is usually achieved using Face mask oxygenation and bag-mask ventilation with risk of gastric insufflation, leading to increased intragastric pressure and raised risk of pulmonary aspiration of stomach contents. High flow nasal cannula (HFNC) oxygenation is gaining popularity in modern anaesthesia with an increase of apneic oxygenation time, causing continuous positive airway pressure and carbon dioxide clearance. However, data on gastric insufflation during HFNC oxygenation is sparse. Hence we aim to compare gastric insufflation during HFNC oxygenation and conventional face mask ventilation in adult anaesthesia using objective measurement of ultrasonographic gastric antral area.

After obtaining institutional ethical committee approval, 50 patients requiring general anaesthesia with elective intubation of age group 18 to 60 years belonging to ASA class I to III will be enrolled in this study after obtaining informed consent. Computer generated randomisation will be used to allocate 25 patients in each of the two groups. Study group patients will be receiving HFNC oxygenation using humidified 100% oxygen with initial flows of 40 litres/minute, gradually increasing flows to 70 litres/minute over one minute and continued during induction till completion of intubation along with jaw thrust after induction. The control group patients will be receiving conventional face mask preoxygenation using fresh gas flows of 10 litres/minute 100% oxygen with snuggly held face mask via a breathing system of anaesthesia workstation until induction followed by volume controlled ventilation using a tidal volume of 8ml/kg with a frequency of 12 breaths/minute along with oral airway and jaw thrust until intubation.

For all patients to assess gastric insufflation during preoxygenation, gastric antral area will be measured using low frequency curvilinear probe of ultrasound prior to start of preoxygenation as baseline values and just prior to intubation. The appearance of comet tail sign in gastric antrum during preoxygenation using continuous ultrasonographic assessment will be recorded as a subjective finding of gastric insufflation. Arterial line will be secured to all patients for collecting ABG samples prior to preoxygenation, prior to induction and prior to intubation in assessing the rise in PaCOvalues.

Data recorded in case report forms will be entered in an excel sheet for statistical calculation and analysis using statistical methods student t test and chi-square test. P value <0.05 will be considered as significant.

 
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