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Comparison between two airway devices i-gel vs Laryngeal mask airway-unique on easiness of insertion during general anaesthesia

Comparison between two supraglottic airway devices i-gel vs Laryngeal mask airway-unique on easiness of insertion during general anaesthesia

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2011/11/002168
Enrollment
20
Registered
2011-11-25
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- Anaesthesia

Interventions

Intervention1: i-gel supraglottic airway device: After an adequate depth of anesthesia and muscle relaxation ,the i-gel size 3, 4 or 5 is inserted according to the manufacturers instructions. Size sel

Sponsors

Government medical college Thiruvananthapuram
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: ASA 1 - Healthy patient without organic, biochemical, or psychiatric disease ASA 2 - A patient with mild systemic disease, e.g., mild asthma or well-controlled hypertension. No significant impact on daily activity. Unlikely to have an impact on anesthesia and surgery

Exclusion criteria

Exclusion criteria: ASA 3- Significant or severe systemic disease that limits normal activity, e.g., renal failure on dialysis or class 2 congestive heart failure. Significant impact on daily activity. Probable impact on anesthesia and surgery ASA 4-Severe disease that is a constant threat to life or requires intensive therapy, e.g., acute myocardial infarction, respiratory failure requiring mechanical ventilation. Serious limitation of daily activity. Major impact on anesthesia and surgery ASA 5-Moribund patient who is equally likely to die in the next 24 hours with or without surgery ASA 6-Brain-dead organ donor Duration of surgery more than 2 hours Emergency surgery Surgery in positions other than supine Pathology of neck or upper repiratory tract Potential difficult intubation Mouth opening less than 2.5 cms Pregnant women BMI more than 35 kg/m2 Patients with reported hypersensitivity for one or more medications and latex Increased risk of aspiration ( hiatus hernia , gastro esophageal reflux , full stomach )

Design outcomes

Primary

MeasureTime frame
Duration of insertionTimepoint: Time from picking up the device to first successful breath made by manual ventilation

Secondary

MeasureTime frame
Hemodynamic effectsTimepoint: Pulse Rate , Blood Pressure (systolic , diastolic & mean) , Oxygen saturation are monitored and recorded.;Leak volumesTimepoint: The difference between inspired tidal volume (ITV) and expired tidal volume (ETV);Number of insertion attemptsTimepoint: A failed attempt is defined as removal of the device from the mouth before re-insertion.;Perioperative ComplicationsTimepoint: Bronchospasm ,Laryngospasm and coughing , trauma , postoperative sore throat (constant pain, independent of swallowing), dysphagia (difficulty or pain with swallowing), dysphonia (difficulty or pain with speaking);Reposition attemptsTimepoint: Manipulations allowed: gentle pushing or pulling of the device, chin lift, jaw thrust, head extension, or neck flexion.;Sealing pressure (airway leak pressure)Timepoint: Measuring the minimal airway pressure at which an audible gas leak occurred using a stethoscope placed just lateral to thyroid cartilage.

Countries

India

Contacts

Public ContactDr Arun Raj M

Government Medical College , Thiruvananthapuram

k_rajm@yahoo.com

Outcome results

None listed

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