To study and compare the occurrence of stomach insufflation (air entry into the stomach) during manual breathing using bag-mask device and during oxygen supplementation using high-flow nasal oxygen device at the induction of general anesthesia in patients undergoing emergency surgery.

Gastric insufflation with face mask ventilation using modified rapid sequence induction compared with pre and apnoeic oxygenation using high flow nasal oxygen during induction of general anaesthesia in patients undergoing emergency surgery: A prospective randomised controlled trial. - NIL

Status

Recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/12/060631

Enrollment

144

Registered

2023-12-21

Start date

Unknown

Completion date

Unknown

Last updated

2024-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: RSI with THRIVE: All patients will be pre-oxygenated for 3 minutes using THRIVE which will be continued during induction of anaesthesia till tracheal intubation. After tracheal intubati

Eligibility

Inclusion criteria

Inclusion criteria: 1. Adult patients aged more than 18 years, 2. Belonging to American Society of Anaesthesiologists (ASA) Physical Status 1-3, 3. Belonging to either sex, 4. Scheduled for emergency surgery under GA.

Exclusion criteria

Exclusion criteria: 1. Patient who refuse to participate, 2. Pregnant female, 3. Patients with known gastro-oesophageal reflux such as in hiatus hernia, 4. Patients with conditions leading to delayed gastric emptying e.g. autonomic gastroparesis (diabetes mellitus, Parkinson’s disease), history of gastric banding surgery, patients with recent administration of opioids.

Design outcomes

Primary

Measure	Time frame
To compare the incidence of gastric insufflation (air leak into the stomach) between two techniques.Timepoint: At baseline and immediately after endotracheal intubation.	—

Secondary

Measure	Time frame
1. To compare change in gastric volume as calculated by ultrasound assessment of antral cross-sectional area (CSA) between two techniques. 2. To compare changes in the blood gas parameters (pH, PaO2 and PaCO2) at predefined time points [before surgery (T1), following pre-oxygenation and before induction of anaesthesia (T2) and after intubation before initiating mechanical ventilation (T3)] between two techniques. 3.To compare symptoms suggestive of gastric insufflation between two techniques. 4.To compare peristaltic contractions of gastric antrum between two techniques. 5. To find out the risk factor for gastric insufflation. Timepoint: First 24 hours postoperative period	—

Measure

Time frame

1. To compare change in gastric volume as calculated by ultrasound assessment of antral cross-sectional area (CSA) between two techniques. 2. To compare changes in the blood gas parameters (pH, PaO2 and PaCO2) at predefined time points [before surgery (T1), following pre-oxygenation and before induction of anaesthesia (T2) and after intubation before initiating mechanical ventilation (T3)] between two techniques. 3.To compare symptoms suggestive of gastric insufflation between two techniques. 4.To compare peristaltic contractions of gastric antrum between two techniques. 5. To find out the risk factor for gastric insufflation. Timepoint: First 24 hours postoperative period

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Countries

India

Contacts

Public ContactMansi Shrivastava

AIIMS JODHPUR

drmsadik@gmail.com9414849733

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026