Evaluation of a medical device used in anaesthesia for securing airway- AMBU AuraGainâ?¢

Evaluation of clinical use and performance characteristics of AMBU AuraGainâ?¢

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2016/10/007366

Enrollment

100

Registered

2016-10-14

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- Patients undergoing elective surgery and requiring general anaesthesia

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: All patients in whom AMBU AuraGain is inserted ASA I/II

Exclusion criteria

Exclusion criteria: 1. History of gastroesophageal reflux 2. Abnormal airway anatomy or anticipated difficult intubation 3. BMI > 30kg/m2

Design outcomes

Primary

Measure	Time frame
1. Ease of placement of device 2. To determine the position of the ventilating orifice in relation to the larynx using a fibreoptic bronchoscope, 3. To test its efficacy as a conduit for fibreoptic intubation with cuffed tracheal tubes in paralyzed adult patients Timepoint: Ease of placement of device- will be seen during insertion of device Position of the ventilating orifice in relation to the larynx using a fibreoptic bronchoscope -will be assesed after insertion of device Efficacy as a conduit for fibreoptic intubation with cuffed tracheal tubes- will be assesed during intubation through the device	—

Measure

Time frame

1. Ease of placement of device 2. To determine the position of the ventilating orifice in relation to the larynx using a fibreoptic bronchoscope, 3. To test its efficacy as a conduit for fibreoptic intubation with cuffed tracheal tubes in paralyzed adult patients Timepoint: Ease of placement of device- will be seen during insertion of device Position of the ventilating orifice in relation to the larynx using a fibreoptic bronchoscope -will be assesed after insertion of device Efficacy as a conduit for fibreoptic intubation with cuffed tracheal tubes- will be assesed during intubation through the device

—

Secondary

Measure	Time frame
Ability to remove the ILA without dislodgement of the tracheal tube Timepoint: Immediately after successful tracheal intubation. ;Hemodynamic changes after insertion of deviceTimepoint: 1 minute, 3 minutes and 5 minutes after insertion of AMBU AuraGain	—

Countries

India

Contacts

Public ContactDevangi Parikh

Lokmanya Tilak Municipal General Hospital

sdevangi10@gmail.com

Outcome results