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
|
|
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
|
|
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 PaCO2 values. 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. |