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Comparison of the Clinical Performance of three airway devices(Ambu Auragain, Blockbuster and Protector laryngeal mask airway) in patients undergoing surgery under general anaesthesia

Comparison of the clinical performance of ambu auragain, blockbuster and protector laryngeal mask airway in paralyzed anesthetized patients. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/11/059416
Enrollment
120
Registered
2023-11-02
Start date
Unknown
Completion date
Unknown
Last updated
2023-11-13

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: Ambu Auragain, Blockbuster and Protector Laryngeal mask airway: To compare the clinical performance of Ambu Auragain, Blockbuster and Protector laryngeal mask airway in paralysed anaest

Sponsors

Department of Anaesthesia and Intensive care GMCH Chandigarh
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age between 18 -60 years of either sex 2. Patients with American Society of Anaesthesiologist (ASA) physical status class I II 3. Patients undergoing elective surgery requiring controlled ventilation under general anaesthesia

Exclusion criteria

Exclusion criteria: 1. Patients with anticipated difficult airway( Airway Difficulty score >8) 2. Morbid obesity (BMI >35Kg/m2) 3. Pregnant women 4. Major maxilla-facial trauma or cervical spine pathology 5. Severe cardiorespiratory, cerebrovascular, renal, hepatic or musculoskeletal diseases 6. Severe coagulopathy or history of anticoagulant use 7. Patient at increased risk of pulmonary aspiration such as gastroesophageal reflux disease, peptic ulcer disease. 8. Surgery in prone position

Design outcomes

Primary

MeasureTime frame
To compare oropharyngeal leak pressure of Ambu AuraGain, Blockbuster and Protector laryngeal mask airway in paralysed anaesthetised patientsTimepoint: To compare oropharyngeal leak pressure of Ambu AuraGain, Blockbuster and Protector laryngeal mask airway immediately and 5 minutes after successful insertion of the device which will be determined by presence of normal thoracoabdominal movement and a square wave capnograph on monitor while ventilating the patients.

Secondary

MeasureTime frame
Any other complications- device displacement, soft tissue oedema , dental trauma, blood stain on study deviceTimepoint: Device displacement, soft tissue oedema, dental trauma after successful insertion of the device & during the surgical procedure. Blood stain on study device immediately after removal of the device.;Complications such as sore throat, stridor or hoarsenessTimepoint: Complications such as sore throat, stridor or hoarseness after removing the device & shifting the patient in recovery room.;To compare fibreoptic assessment of glottic view through the deviceTimepoint: Fibreoptic assessment of glottic view through the device after successful insertion which will be determined by normal thoracoabdominal movements & a square wave capnograph on monitor while ventilating the patients.;To compare first attempt success rate of the device Timepoint: First attempt successful placement of the device will be identified just after insertion of the device by presence of normal thoracoabdominal movements & a square wave capnograph on monitor while ventilating the patients.;To compare hemodynamic parametersTimepoint: To compare hemodynamic parameters preoperatively,just before insertion, immediately after insertion, 1 minute, 5 minutes & 10 minutes after insertion of the device.;To compare insertion time of deviceTimepoint: Time taken for insertion of the device started with removal of face mask & ended with normal thoracoabdominal movements & square wave capnograph on monitor while ventilating the patients.;To compare number of insertion attempts of the deviceTimepoint: Number of attempts for successful device insertion will be determined just after insertion of device by the presence of normal thoracoabdominal movement & a square wave capnograph on monitor while ventilating the patients.

Countries

India

Contacts

Public ContactDr Dheeraj Kapoor

Government Medical College and Hospital, Sector 32, Chandigarh

kapoor.dheeraj72@gmail.com9646121549

Outcome results

None listed

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