Comparison of three techniques of face mask ventilation in patients undergoing surgery.

Not yet recruiting

Conditions: Neoplasms,

Registration Number: CTRI/2025/04/084755

Lead Sponsor: ACTREC, Tata memorial centre

Brief Summary: **Comparison of three techniques of two hand face mask ventilation:Prospective**

**randomized crossover trial in patients undergoing elective surgery.**

Written informed consent for participation in this study will be obtained one day prior to surgery from all ASA 1-3

adults patients (18-65 years, with no anticipated difficult airway) scheduled to

undergo elective surgery under general anaesthesia, with the use of non-

depolarising muscle relaxant, during the two year study duration, in our institute. All

the patients will be explained the sequence of events that will be occurring during

induction of anaesthesia. A detailed discussion about face mask ventilation, airway

management before surgery, anaesthesia protocol and its inherent risks ,benefits

and safety measures will be done with them. Their demographic details including

age ,sex, weight, any comorbidities along with their treatment, etc will be noted.

initial hemodynamic parameters like HR, BP, SPO2 and ECG rhythm will be noted.

After adequate preoxygenation, anaesthesia inducing agents and non-depolarising

muscle relaxant will be given(confirmed with TOF). Three types of two hand face

mask ventilation will be tried under volume control mode of ventilation with fixed

respiratory parameters, and corresponding Expiratory tidal volume, EtCO2 and Peak

inspiratory pressure are noted from ventilator machine. The patient will be monitored

with HR, BP, SPO2, and ECG throughout the procedure.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 161

Inclusion Criteria

ASA I-III adult patients (18.
65 years) scheduled to undergo elective surgery under general anaesthesia, with the use of non-depolarising muscle relaxant, will be included.

Exclusion Criteria

1.Pediatric patients 2.Patients greater than or equal to 66 years of age 3.Patients at risk of aspiration such as pregnant patients, patients with gastro-intestinal obstruction, uncontrolled diabetes mellitus etc 4.
Patients undergoing Emergency surgery 5.
Patients with anticipated difficult mask ventilation such as patients with a history of previous surgery, radiation, trauma, burns or mass (benign or malignant) in the airways or the cranial, cervical and facial regions, patients with restricted neck and mandible mobility (rheumatoid arthritis, cervical disc disorders, or temporomandibular joint disorders) 6.
Patients with beard 7.
Edentulous patients 8.
Body mass index (BMI) greater than 30 kg/m2 or less than 18.5 kg/m2 9.
Patients with history of snoring or obstructive sleep apnoea.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the difference between the set tidal volume (TV) and expired TV on controlled ventilation, of these three types of two hand face mask ventilation.	Ten consecutive breaths with each technique with a time break of 10 to 20 seconds between each techniques.

Secondary Outcome Measures

Name	Time	Method
To compare the end tidal carbon dioxide (ETCO2) graph as per the Concord	grading scale for facemask ventilation

Trial Locations

Locations (1): ACTREC
🇮🇳
Mumbai, MAHARASHTRA, India
ACTREC
🇮🇳Mumbai, MAHARASHTRA, India
Dr Athul R G
Principal investigator
9656446880
atulrg995@gmail.com