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Comparative study to see the gastric volume in two airway device groups

Comparison between proseal laryngeal mask airway and endotracheal intubation in lower abdominal surgeries for perioperative gastric volume assessment and recovery of gastrointestinal function - a randomised control trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/07/044102
Enrollment
72
Registered
2022-07-18
Start date
Unknown
Completion date
Unknown
Last updated
2022-08-02

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: Proseal LMA vs endotracheal tube for gastric inflation: Randomization will be done by computer generated random number tables and groups will be assigned by opening sealed sequentially

Sponsors

AIIMS rishikesh
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age >= 18 years and 2. BMI 3. American Society of Anesthesiologists (ASA) grading I-II. 4. Posted electively for laparoscopic lower abdominal procedures

Exclusion criteria

Exclusion criteria: 1. Preoperative sore throat and/or hoarseness. 2. Known risk of gastric aspiration. 3. Mallam Pati grade 3 or 4. 4. Facial and upper airway abnormalities that make mask ventilation and tracheal intubation difficult. 5. Hiatus hernia. 6. Pregnant and breastfeeding females. 7. Anticipated difficult intubation 8. Full stomach

Design outcomes

Primary

MeasureTime frame
Antral cross-sectional area, as measured by ultrasoundTimepoint: time points(baseline, Immediately after induction, at 1 hour, at the end of surgery and 1 hour post surgery)

Secondary

MeasureTime frame
Vital parameters (Heart Rate, Systolic Blood Pressure, Diastolic BP, MAP, SpO2, ETCO2)and intra abdominal pressure Ventilation parameters (TV, Leak Fraction, Leak Volume, Peak pressure, plateau pressure) Time (in hour minutes) to tolerance of clear fluids Time(in hour minutes) to tolerance of Light diet Time (in hour minutes) to achieve first bowel movement or first flatus, whichever is earlier Length of stay and days to discharge in patients Timepoint: time points(baseline, Immediately after induction, at 1 hour, at the end of surgery and 1 hour post surgery)

Countries

India

Contacts

Public ContactRanjay

All India Institute of Medical Sciences, Rishikesh

bhavna.kakkar@gmail.com8527686660

Outcome results

None listed

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