CTRI

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CTRI Number

CTRI/2024/11/076366 [Registered on: 07/11/2024] Trial Registered Prospectively

Last Modified On:

29/10/2024

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Surgical/Anesthesia

Study Design

Other

Public Title of Study

Estimation of ultrasound-guided gastric insufflation during induction of general anaesthesia using High Frequency Nasal Oxygenation and Pressure Controlled Facemask Ventilation

Scientific Title of Study

Estimation Of Ultrasound-Guided Gastric Insufflation During Induction Of General Anaesthesia Using High-Frequency Nasal Oxygenation And Pressure-Controlled Facemask Ventilation-A Comparative 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	Abhay Dwivedi
Designation	Post graduate student
Affiliation	ABVIMS and Dr. RML Hospital
Address	Room no. 301, 3rd floor Department of Anaesthesia, ABVIMS and Dr. RML Hospital Central DELHI 110001 India
Phone	7982354542
Fax
Email	abhaydwivedi46@yahoo.com

Details of Contact Person
Scientific Query

Name	Dr Prof Neerja Banerjee
Designation	Consultant and Head of Department
Affiliation	ABVIMS and Dr. RML Hospital
Address	Room no. 301, 3 rd floor Department of Anaesthesia, ABVIMS and Dr. RML Hospital Central DELHI 110001 India
Phone	9810517575
Fax
Email	neerja.banerjee@gmail.com

Details of Contact Person
Public Query

Name	Abhay Dwivedi
Designation	Post graduate student
Affiliation	ABVIMS and Dr. RML Hospital
Address	Room no. 301, 3 rd floor Department of Anaesthesia, ABVIMS and Dr. RML Hospital Central DELHI 110001 India
Phone	7982354542
Fax
Email	abhaydwivedi46@yahoo.com

Source of Monetary or Material Support

ABVIMS and Dr. Ram Manohar Lohia Hospital, Baba Kharak Singh Marg, Near Gurudwara Bangla Sahib, Connaught Place, New Delhi, Delhi 110001 Central DELH

Primary Sponsor

Name	NIL
Address	NIL
Type of Sponsor	Other [NIL]

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 Abhay Dwivedi	ABVIMS and Dr. Ram Manohar Lohia Hospital, New Delhi	Room no. 301 , 3 rd floor Department of Anaesthesia, ABVIMS & Dr. RML Hopsital Central DELHI	7982354542 abhaydwivedi46@yahoo.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Institutional Ethics Committee ABVIMS and RML Hospital, New Delhi	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	Oxygenation using High Frequency Nasal Oxygenation and Pressure Controlled Facemask Ventilation.	Oxygenation using either methods for three minutes.
Comparator Agent	Ultrasound guided estimation of gastric insufflation with High Frequency Nasal Oxygenation and Pressure Controlled Facemask Ventilation.	Estimation of gastric insufflation before oxygenation and after three of oxygenation using either methods.

Inclusion Criteria

Age From	18.00 Year(s)
Age To	65.00 Year(s)
Gender	Both
Details	ASA Class I & II patients.

ExclusionCriteria

Details

1. Any anticipated difficult airway including altered anatomy like cervical fractures, maxillofacial abnormalities, restricted neck movement, neck swelling/mass.
2. BMI > 30 kg/m2.
3. Patients with a history of respiratory disorders.
4. Patients at risk of aspiration.
5. Pregnant patients

Method of Generating Random Sequence

Computer generated randomization

Method of Concealment

Not Applicable

Blinding/Masking

Investigator Blinded

Primary Outcome

Outcome	TimePoints
Ultrasound-guided measurement of longitudinal and anteroposterior diameters (D1 and D2) to calculate cross-sectional area (CSA) of gastric antrum in both groups.	At: 1. before oxygenation 2. at loss of consciousness 3. 3 minutes after oxygenation by either method

Secondary Outcome

Outcome	TimePoints
1. Real-time ultrasound-guided observation of the left paratracheal oesophagus for detecting air entry. 2. Measurement of oxygenation .	1. Real-time ultrasound-guided observation of the left paratracheal oesophagus for detecting air entry during the three minutes of oxygenation. 2. Measurement of oxygenation : a. Baseline SpO2 . b. SpO2 after 3 minutes of oxygenation.

Target Sample Size

Total Sample Size="114"
Sample Size from India="114"
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)

10/11/2024

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="3"
Days="20"

Recruitment Status of Trial (Global)

Not Applicable

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

This is a ramdomised comparative study estimating ultrasound-guided gastric insufflation during induction of general anaesthesia using High-Frequency Nasal Oxygenation and Pressure-Controlled Facemask Ventilation. This study has sample size of 114 patients aged 18 to 65 years.There are very few literatures estimating gastric insufflation using ultrasonography during induction of general anaesthesia for comparison of High-Frequency Nasal Oxygenation and Pressure-Controlled Facemask Ventilation.