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

A Comparative Study of the Baska Mask Vs Proseal Laryngeal Mask Regarding Airway Sealing Pressure According to Confirmation by Fiberoptic Position

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 ).

Study Overview

• Status: Completed
• Conditions: Baska Mask
• Intervention / Treatment: Device: Group A : Baska Mask Airway; Device: Group B: Proseal Laryngeal Mask Airway

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

• Study Type: Interventional
• Enrollment (Actual): 74
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11451
    • Ahmed Abdalla Mohamed

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 ).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: 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	Device: 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
ACTIVE_COMPARATOR: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Laryngeal view grades recorded by fiberoptic bronchoscopes.	fiberoptic bronchoscopes can record Laryngeal view grades	15 Minutes
Device Complications:	Patients will be monitoring for the following complications: arterial oxygen desaturation, lip damage; blood staining on mask removal and laryngospasm, the incidence and severity of throat pain, dysphagia, Heart burn, Nausea and Vomiting at arrival and discharge from the recovery unit and on the first postoperative day	Through study completion

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 5, 2018
• Primary Completion (ACTUAL): February 5, 2019
• Study Completion (ACTUAL): February 7, 2019

Study Registration Dates

• First Submitted: January 11, 2019
• First Submitted That Met QC Criteria: January 18, 2019
• First Posted (ACTUAL): January 22, 2019

Study Record Updates

• Last Update Posted (ACTUAL): February 20, 2019
• Last Update Submitted That Met QC Criteria: February 18, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: N_50_2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Till Press

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No