Assessment of new airway device [Gnana Laryngeal Airway]: a preliminary clinical study.

To evaluate a novel airway device, Gnana Laryngeal Airway in clinical practice: A pilot study.

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Observational

Source

CTRI

Registry ID

CTRI/2017/12/010782

Enrollment

Registered

2017-12-06

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- American Society of Anesthesiologists (ASA) I/II patients scheduled for elective surgeries requiring general anaesthesia.

Interventions

Intervention1: NIL: NIL Control Intervention1: NIL: NIL

Eligibility

Inclusion criteria

Inclusion criteria: 1. American Society of Anesthesiologist (ASA) physical status 1 and 2 of either sex 2. Age group: 18-60 years 3. Body Mass Index (BMI): 4. Scheduled for elective surgeries with duration 5. No concurrent participation in another study

Exclusion criteria

Exclusion criteria: 1. Patientsâ?? refusal or inability to give informed consent 2. American Society of Anesthesiologist (ASA) >=3 physical status of either sex 3. Emergency surgical procedures 4. Upper respiratory tract infection 5. Anticipated difficult airway 6. Patients at increased risk of aspiration -gastro esophageal reflux disease, non fasting status, pregnancy 7. Cardiorespiratory or cerebrovascular disease 8. Diabetes Mellitus

Design outcomes

Primary

Measure	Time frame
Ease of insertion grade of Gnana laryngeal airway device.Timepoint: Immediately Post-induction of general anaesthesia. [Single time point]	—

Secondary

Measure	Time frame
1.Time taken for Gnana laryngeal airway device insertion. 2. Oropharyngeal Leak Pressure of Gnana airway device. 3. Fibreoptic view grade of glottis after placement of Gnana airway device. 4. Ventilation variables [Peak airway pressure, Airway Resistance, Airway Compliance, Pulse oximetry, End-Tidal carbon dioxide pressure] 5. Any Malposition of Gnana laryngeal airway device. 6. Adverse effects post Gnana laryngeal airway device insertion. Timepoint: 1. Immediately Post-induction of general anaesthesia 2. Immediately and 5 minutes after Gnana device insertion. 3.Immediately and 5 minutes after Gnana device insertion. 3. Immediately after Gnana device insertion. 4. Pre-induction of general anaesthesia, Immediate post-induction of general anaesthesia, Immediately post-Gnana device insertion, 5 minutes post Gnana device insertion 5. Immediately after Gnana device insertion 6. Immediately, 2 hours and 24 hours after Gnana device removal.	—

Measure

Time frame

1.Time taken for Gnana laryngeal airway device insertion. 2. Oropharyngeal Leak Pressure of Gnana airway device. 3. Fibreoptic view grade of glottis after placement of Gnana airway device. 4. Ventilation variables [Peak airway pressure, Airway Resistance, Airway Compliance, Pulse oximetry, End-Tidal carbon dioxide pressure] 5. Any Malposition of Gnana laryngeal airway device. 6. Adverse effects post Gnana laryngeal airway device insertion. Timepoint: 1. Immediately Post-induction of general anaesthesia 2. Immediately and 5 minutes after Gnana device insertion. 3.Immediately and 5 minutes after Gnana device insertion. 3. Immediately after Gnana device insertion. 4. Pre-induction of general anaesthesia, Immediate post-induction of general anaesthesia, Immediately post-Gnana device insertion, 5 minutes post Gnana device insertion 5. Immediately after Gnana device insertion 6. Immediately, 2 hours and 24 hours after Gnana device removal.

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Countries

India

Contacts

Public ContactDHEERAJ KAPOOR

Govt. Medical College and Hospital, Chandigarh

kapoor.dheeraj72@gmail.com9646121549

Outcome results

None listed

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