A Comparative Study of the Baska Mask Vs Proseal Laryngeal Mask Regarding Airway Sealing Pressure

NCT ID: NCT03812081

Last Updated: 2019-02-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-05
• Study Completion Date: 2019-02-07

Brief Summary

Baska mask air way(BM) in comparative study with Proseal laryngeal mask airway (PLMA) regarding performance of Baska mask improves the safety and efficacy of airway management for in patients undergoing general anesthesia by mechanical ventilation confirmation of position by fiber optic view of glottis opening and success of gastric tube insertion , Airway sealing pressure, Leak fraction, insertion time and "overall insertion" success rates, and post-operative complications (airway trauma, hoarseness, sore throat and Dysphagia ).

Detailed Description

Maintenance of a patent airway is a major responsibility for the anesthesiologists, interruption of gas exchange, even for a few minutes, can result in catastrophic outcomes such as brain damage or death.

Supraglottic airway devices are devices that ventilate patients by delivering anaesthetic gases/oxygen above the level of the vocal cord. Since the development of the laryngeal mask airway, many other supraglottic devices have been introduced in the clinical practice of airway management, trying to offer a simple and effective alternative to endotracheal tube.

However, following experience with such simple cases, clinicians soon become comfortable with more complex cases, such as cases of longer duration, cases with sicker patient reported favorable outcomes in safety profile, risk, ease of insertion, recovery of patients and cost analyses. However, there is an under reporting of complications aris¬ing during ventilation with this device and the risk factors associated with such complications in adult patients. These include Hypoxia, laryngospasm, and difficulty with insertion, suboptimal ventilation, bronchospasm, aspiration, desaturation, hy¬potension and conversion to intubation with ETT. These can be significantly serious and life threatening

Conditions

Baska Mask

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: DOUBLE

Study Groups

Group B Proseal Mask

In which Laryngeal Mask Airway- Proseal LMA (size 3,4,5) was used for ventilation according of patient body weight.Size selection is based on the manufacturer's recommendation of weight-based estimate plus clinical judgment.

Group Type: ACTIVE_COMPARATOR

Group B: Proseal Laryngeal Mask Airway

Intervention Type: DEVICE

Proseal LMA (size 3,4,5) was used for ventilation according of patient body weight.Size selection is based on the manufacturer's recommendation of weight-based estimate plus clinical judgment.

Group A Baska Mask

In which Baska Mask Airway (size 3,4,5) will used for ventilation according of patient body weight.Size selection is based on the manufacturer's recommendation of weight-based estimate plus clinical judgment. The Baska Mask is available in four sizes: size three (30 to 50 kg), size four (50 to 70 kg), size five (70 to 100 kg),The membranous cuff of the Baska Mask appears bulkier than the equivalent inflatable cuff on cuffed laryngeal masks. The mask can easily be decreased in size during insertion by compressing the proximal, firmer part of the mask below the airway tube, between the thumb and two fingers

Group Type: ACTIVE_COMPARATOR

Group A : Baska Mask Airway

Intervention Type: DEVICE

Size selection is based on the manufacturer's recommendation of weight-based estimate plus clinical judgment. The Baska Mask is available in four sizes: size three (30 to 50 kg), size four (50 to 70 kg), size five (70 to 100 kg),The membranous cuff of the Baska Mask appears bulkier than the equivalent inflatable cuff on cuffed laryngeal masks. The mask can easily be decreased in size during insertion by compressing the proximal, firmer part of the mask below the airway tube, between the thumb and two fingers

Interventions

Group A : Baska Mask Airway

Size selection is based on the manufacturer's recommendation of weight-based estimate plus clinical judgment. The Baska Mask is available in four sizes: size three (30 to 50 kg), size four (50 to 70 kg), size five (70 to 100 kg),The membranous cuff of the Baska Mask appears bulkier than the equivalent inflatable cuff on cuffed laryngeal masks. The mask can easily be decreased in size during insertion by compressing the proximal, firmer part of the mask below the airway tube, between the thumb and two fingers

Intervention Type: DEVICE

Group B: Proseal Laryngeal Mask Airway

Proseal LMA (size 3,4,5) was used for ventilation according of patient body weight.Size selection is based on the manufacturer's recommendation of weight-based estimate plus clinical judgment.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Healthy adult ASA I-II patients,

2. Both genders, aged 18-45 years,

3. Body weight between 50 and 90 kg who BMI > 30 kg/m2

4. Non-urgent surgery of planned duration up to 2 hrs

Exclusion Criteria

1. Patient refusal

2. Patients having known tendency to nausea/vomiting or pharyngeal pathology

3. Morbid obese patients with body mass index >30 kg/m2

4. Patients known to have gastro-esophageal reflux disease (GERD), hiatus hernia or previous upper gastrointestinal tract surgery

5. History of difficult intubation, measured the common predictive indices for difficult intubation (BMI, thyromental distance,Mallampati grade, inter-incisor distance, dentition and neck movement ).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Abdalla

Professor of Anesthesia &I.C.U and Pain Clinic, Cairo University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ahmed Abdalla Mohamed

Cairo, , Egypt

Countries

Egypt

Other Identifiers

N_50_2018

Identifier Type: -

Identifier Source: org_study_id