A research to evaluate and compare two medical devices (Air-Q Blocker and ProSeal Laryngeal Mask Airway), used to ventilate patients undergoing general surgery.

Comparative evaluation of Air-Q Blocker and ProSeal Laryngeal Mask Airway in patients undergoing elective surgery under general anaesthesia.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2016/04/006833

Enrollment

Registered

2016-04-19

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: Air-Q Blocker: Will be used to maintain the patency of airway during general anaesthesia. The device will be inserted only after the induction of anaesthesia. Control Intervention1: Pro

Eligibility

Inclusion criteria

Inclusion criteria: The following patients will be included in the study 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: The following patients will be excluded from the study 1.Patients with anticipated difficult airway (Airway Difficulty Score >8) 25 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
To compare the oropharyngeal leak pressure of Air-Q Blocker and ProSeal laryngeal mask airway in patients undergoing elective surgery under general anaesthesiaTimepoint: Immediately after the placement of device	—

Secondary

Measure	Time frame
To evaluate the efficacy of Air-Q Blocker and comparing with ProSeal laryngeal mask airway for device insertion success, ease of gastric tube placement, fibreoptic visualization of glottis, hemodynamic and ventilatory parameters in patients undergoing elective surgery under general anaesthesiaTimepoint: 1. Ease of device insertion, ease of gastric tube placement and fibreoptic visualisation- will be observed immediately after the placement of device. 2.Hemodynamic and ventilatory parameters- will be recorded at the time points- Baseline, after induction, just after device insertion and at 5, 10 and 15 minutes.	—

Measure

Time frame

To evaluate the efficacy of Air-Q Blocker and comparing with ProSeal laryngeal mask airway for device insertion success, ease of gastric tube placement, fibreoptic visualization of glottis, hemodynamic and ventilatory parameters in patients undergoing elective surgery under general anaesthesiaTimepoint: 1. Ease of device insertion, ease of gastric tube placement and fibreoptic visualisation- will be observed immediately after the placement of device. 2.Hemodynamic and ventilatory parameters- will be recorded at the time points- Baseline, after induction, just after device insertion and at 5, 10 and 15 minutes.

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Countries

India

Contacts

Public ContactDr Ankita Mittal

Government Medical College & Hospital, Chandigarh

lkanand11@gmail.com9646121522

Outcome results