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

NCT03812081 | Completed

• 1 other identifier: N_50_2018
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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 ).

Conditions

Baska Mask

Outcome Measures

Primary Outcomes (1)

• Airway sealing pressure in cmH2O

  The airway sealing pressure is the pressure at which leak starts; in cmH2O at 5 mints post placement, this leak pressure will calculate as the plateau airway pressure reach with fresh gas flow 6 l/min, and pressure adjustment valve set at 70 cmH2O, and observing of the rise of the ventilator's airway pressure. A ''puffing'' sound was heard near the patient's mouth (release of pressure) indicating the airway seal pressure

  15 Minutes

Secondary Outcomes (2)

• Laryngeal view grades recorded by fiberoptic bronchoscopes.

  15 Minutes

• Device Complications:

  Through study completion

Study Arms (2)

Group A Baska Mask

ACTIVE COMPARATOR

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

Device: Group A : Baska Mask Airway

Group B Proseal Mask

ACTIVE COMPARATOR

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.

Device: Group B: Proseal Laryngeal Mask Airway

Interventions

Group A : Baska Mask Airway 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

Group A Baska Mask

Group B: Proseal Laryngeal Mask Airway 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 B Proseal Mask

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy adult ASA I-II patients,
• Both genders, aged 18-45 years,
• Body weight between 50 and 90 kg who BMI \> 30 kg/m2
• Non-urgent surgery of planned duration up to 2 hrs

You may not qualify if:

• Patient refusal
• Patients having known tendency to nausea/vomiting or pharyngeal pathology
• Morbid obese patients with body mass index \>30 kg/m2
• Patients known to have gastro-esophageal reflux disease (GERD), hiatus hernia or previous upper gastrointestinal tract surgery
• History of difficult intubation, measured the common predictive indices for difficult intubation (BMI, thyromental distance,Mallampati grade, inter-incisor distance, dentition and neck movement ).

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Ahmed Abdalla Mohamed

Cairo, 11451, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: 72 Patients are randomly divided by computer designed lists and then concealed in closed envelopes into 2 equal groups: Group A (n= 37), in which Baska Mask Airway \ (size 3,4,5) will used for ventilation according of patient body weight. Group B (n= 37), in which Laryngeal Mask Airway- Proseal LMA\ (size 3,4,5) was used for ventilation according of patient body weight
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesia &I.C.U and Pain Clinic, Cairo University

Model Details: Following approval from EL Kasr Al-Ainy teaching hospital ethical committee and an informed patient consent, the investigators enrolled 74adult patients ASA I and II, non-obese (BMI\<30) ranging from18-45 yrs. of age, Patients underwent a variety of elective surgical procedures in the supine position with SAD placement for ≤ 2 hours duration. Patients randomly divided by computer designed lists and then concealed in closed envelopes into 2 equal groups: Group A (n= 37), in which Baska Mask Airway \_ (size 3,4,5) will used for ventilation according of patient body weight. Group B (n= 37), in which Laryngeal Mask Airway- Proseal LMA\_ (size 3,4,5) was used for ventilation according of patient body weight.

Study Record Dates

• First Submitted: January 11, 2019
• First Posted: January 22, 2019
• Study Start: December 5, 2018
• Primary Completion: February 5, 2019
• Study Completion: February 7, 2019
• Last Updated: February 20, 2019

Record last verified: 2019-02

Locations

EG (1)