Comparison between Frova intubating introducer and Gum elastic bougie guided intubation in simulated difficult airway in patients undergoing surgery.

A Comparison of Frova intubating introducer and Gum elastic bougie guided intubation in simulated difficult airway - NIL

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/05/067963

Enrollment

100

Registered

2024-05-28

Start date

Unknown

Completion date

Unknown

Last updated

2024-06-24

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: FROVA intubating introducer: Standardized anaesthesia protocol will be followed. Peripheral intravenous line will be secured with appropriate size cannula. The cervical collar will be p

Eligibility

Inclusion criteria

Inclusion criteria: 100 patients 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 respiratory or pharyngeal pathology, mouth opening 30kg/m2, pregnancy, full stomach, anticipated difficult airway and any patient who refuses to participate in the study will be excluded from the study

Design outcomes

Primary

Measure	Time frame
To evaluate and compare the first pass success rate of intubation through Frova intubating introducer and Gum elastic bougieTimepoint: Mean Arterial Pressure, Heart Rate and SpO2 will be evaluated and observed at Baseline, after induction, One minute after intubation, Three minutes after intubation and Five minutes after intubation	—

Secondary

Measure	Time frame
Number of attempts taken to insert the introducer Total time taken for successful intubation Ease of intubation Optimisation manoeuvres required for intubation Haemodynamic variation Complications secondary to device placement Timepoint: Assessment of Mean Arterial Pressures, Heart Rate and Oxygen saturation will be done at Baseline, After induction, One minute after intubation, Three minutes after intubation and Five minutes after intubation. Data compiled and appropriate statistical tests will be applied to analyze the results.	—

Measure

Time frame

Number of attempts taken to insert the introducer Total time taken for successful intubation Ease of intubation Optimisation manoeuvres required for intubation Haemodynamic variation Complications secondary to device placement Timepoint: Assessment of Mean Arterial Pressures, Heart Rate and Oxygen saturation will be done at Baseline, After induction, One minute after intubation, Three minutes after intubation and Five minutes after intubation. Data compiled and appropriate statistical tests will be applied to analyze the results.

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Countries

India

Contacts

Public ContactDr Anubhav Bhardwaj

Pt.B.D.Sharma PGIMS, Rohtak

anubhavbhardwaj926@gmail.com9354050035

Outcome results

None listed

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