A research to evaluate and compare two medical devices(Proseal laryngeal mask airway and Gnana laryngeal airway II) use to ventilate the patients undergoing elective surgery under general anesthesia.

Comparative evaluation of Proseal laryngeal mask airway with Gnana laryngeal airway II in paralysed patients undergoing elective surgery with controlled ventilation.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2019/04/018839

Enrollment

Registered

2019-04-30

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

None listed

Interventions

Intervention1: Gnana LA II: will be used to maintain the patency of airway during general anaesthesia.will be inserted only once after induction of anaesthesia. Control Intervention1: Proseal Laryngea

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age group between 18 to 60 years 2. American Society of Anaesthesiologist (ASA) physical status I and II. 3. Patients scheduled for elective surgery under general anaesthesia (Duration of surgery 2 Â± 0.5 hrs)

Exclusion criteria

Exclusion criteria: 1. Patients with anticipated difficult airway (Airway Difficulty Score >8).22 2. Patients with upper respiratory tract infection 3. Patients with increased risk of regurgitation and aspiration of gastric content 4. Patients with a body mass index (BMI) > 35 kg.m.-2 5. Patients with past history of radiotherapy to the neck involving the hypopharynx 6. Patients undergoing surgeries involving neck and oral cavity 7. Pregnant patients.

Design outcomes

Primary

Measure	Time frame
1.To compare the oropharyngeak leak pressure ofProSeal laryngeal mask airway with Gnana laryngeal airway II in paralysed patients undergoing elective surgery with controlled ventilation .Timepoint: immediately after the placement of device.	—

Secondary

Measure	Time frame
2.To evaluate the efficacy of ProSeal laryngeal mask airway with Gnana laryngeal airway II for device insertion success, ease of gastric tube placement, fibreoptic visualization of glottis, hemodynamic,ventilatory parameters, amount of oropharyngeal secretions sucked and side effects if any.Timepoint: 1.Ease of insertion,fiberoptic visualization-will be observed immediately after placement of device. 2.Haemodynamic and ventilatory parameters-at 1,2,3,4,5 and 10 minutes	—

Measure

Time frame

2.To evaluate the efficacy of ProSeal laryngeal mask airway with Gnana laryngeal airway II for device insertion success, ease of gastric tube placement, fibreoptic visualization of glottis, hemodynamic,ventilatory parameters, amount of oropharyngeal secretions sucked and side effects if any.Timepoint: 1.Ease of insertion,fiberoptic visualization-will be observed immediately after placement of device. 2.Haemodynamic and ventilatory parameters-at 1,2,3,4,5 and 10 minutes

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Countries

India

Contacts

Public ContactDrJasveer Singh

Government Medical college and Hospital, Sector 32, Chandigarh.

drjassy18@gmail.com9646121664

Outcome results