To study the occurrence of stomach insufflation with air while administering general anaesthesia using two different ventilation techniques in obese patients.

Comparison of gastric insufflation produced during conventional versus modified face mask ventilation during induction of general anaesthesia in obese patients undergoing elective surgery: A prospective randomised double blinded study. - Nil

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/04/065715

Enrollment

Registered

2024-04-15

Start date

Unknown

Completion date

Unknown

Last updated

2024-11-11

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

Conditions

Health Condition 1: J958- Other intraoperative and postprocedural complications and disorders of respiratory system, not elsewhere classified Health Condition 2: O- Medical and Surgical

Interventions

Intervention1: Modified face mask ventilation technique: After induction of general anaestehsia, face mask ventilation will be provided using volume-controlled mode of mechanical ventilation with a Ti

Eligibility

Inclusion criteria

Inclusion criteria: Obese patients having BMI between 30 to 49.9 kg/m2 ASA physical status II and III Age between 18 to 65 years of either sex Adequate fasting status (6h for solids and 2h for clear liquids)

Exclusion criteria

Exclusion criteria: Patients having comet tail appearance prior to induction (baseline) Failure to obtain clear ultrasonographic images Drugs affecting the dynamics of gastrointestinal system History of esophageal or gastrointestinal trauma or surgery Failed facemask ventilation in either group (An experienced anaesthetist fails to maintain SpO2 of above 90% using 100% O2 with bag and mask ventilation with two hand techniques and use of oral airway) More than one attempt at endotracheal intubation Esophageal intubation Occurrence of gastric content regurgitation or aspiration

Design outcomes

Primary

Measure	Time frame
Number of patients who develop a new ‘comet tail sign’ suggestive of gastric insufflation after induction compared to preinductionTimepoint: At 0 and 10 minutes	—

Secondary

Measure	Time frame
Change in cross sectional area (CSA) of gastric antrum (measured using gastric ultrasound) and gastric volume (calculated using Bouvet equation) after induction compared to preinductionTimepoint: At 0 and 10 minutes;Change in arterial partial pressure of oxygen (PaO2), carbon dioxide (PaCO2), pH value and bicarbonate (HCO3-) at T1, T2 and T3 time intervalsTimepoint: At 0, 2 and 5 minutes;Postoperative symptoms suggestive of gastric distention (bloating, burping, flatulence) and Post-operative Nausea and Vomiting (PONV)Timepoint: At 0 and 1 hour	—

Measure

Time frame

Change in cross sectional area (CSA) of gastric antrum (measured using gastric ultrasound) and gastric volume (calculated using Bouvet equation) after induction compared to preinductionTimepoint: At 0 and 10 minutes;Change in arterial partial pressure of oxygen (PaO2), carbon dioxide (PaCO2), pH value and bicarbonate (HCO3-) at T1, T2 and T3 time intervalsTimepoint: At 0, 2 and 5 minutes;Postoperative symptoms suggestive of gastric distention (bloating, burping, flatulence) and Post-operative Nausea and Vomiting (PONV)Timepoint: At 0 and 1 hour

—

Countries

India

Contacts

Public ContactDr Priyanga

All India Institute of Medical Sciences, Mangalagiri

ghanshambiyani100@gmail.com8764439671

Outcome results

None listed

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