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Comparison between EZEE O2 intubating introducer and Coude tip bougie guided intubation in simulated difficult airway in patients undergoing surgery

A Comparison of Coude Tip Bougie versus EZEE O2 intubating introducer guided intubation in a simulated difficult airway in adult patients - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/11/097439
Enrollment
100
Registered
2025-11-14
Start date
Unknown
Completion date
Unknown
Last updated
2025-11-17

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

Conditions

None listed

Interventions

Intervention1: EZEE O2 Intubating Introducer -: The EZEE O2 ET introducer, very similar to FROVA, is a 15 FG, 70cm long, newer intubating introducer to tackle anticipated or unanticipated difficult ai

Sponsors

Pandit B D Sharma PGIMS Rohtak Haryana
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Hundred patients of either sex aged 18-60 years belonging to American Society of Anaesthesiologists (ASA) physical status I or II scheduled for elective surgery under general anaesthesia requiring endotracheal intubation will be included in the study.

Exclusion criteria

Exclusion criteria: Patients having - 1. respiratory or pharyngeal pathology, 2. restricted mouth opening, 3. body mass index greater than 30 kg/m2, 4. pregnancy, 5. full stomach, 6. anticipated difficult airway and 7. any patient who refuses to participate in the study.

Design outcomes

Primary

MeasureTime frame
To evaluate and compare the first pass success rate of intubation through EZEE O2 intubating introducer and Coude Tip Bougie in a simulated difficult airway in adult patients Timepoint: Mean Arterial Pressure, Heart Rate and SpO2 will be evaluated and observed at Baseline, after induction, 1 minute after intubation, 3 minutes after intubation, 5 minutes after intubation and 10 minutes after intubation—

Secondary

MeasureTime frame
1. Number of attempts taken to insert the introducer 2. Total time taken for successful intubation 3. Ease of intubation 4. Optimisation manoeuvres required for intubation 5. Haemodynamic variations secondary to intubation 6. Complications secondary to device placement (if any) Timepoint: Assessment of Mean Arterial Pressures, Heart Rate & Oxygen saturation will be done at Baseline, After induction, 1 minute after intubation, 3 minutes after intubation, 5 minutes after intubation & 10 minutes after intubation. Data compiled and appropriate statistical tests will be applied to analyze the results.—

Countries

India

Contacts

Public ContactDr Garima Anant

Pt. B. D. Sharma PGIMS, Rohtak, Haryana

dranjughai@gmail.com9416974794

Outcome results

None listed

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