Clinical trial NCT03812081: A Comparative Study of the Baska Mask Vs Proseal Laryngeal Mask Regarding Airway Sealing Pressure
Official title: A Comparative Study of the Baska Mask Vs Proseal Laryngeal Mask Regarding Airway Sealing Pressure According to Confirmation by Fiberoptic Position
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Baska Mask
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-01-22
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: DIAGNOSTIC

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

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 ).

Primary outcomes:
measure: Airway sealing pressure in cmH2O
timeFrame: 15 Minutes
Secondary outcomes:
measure: Laryngeal view grades recorded by fiberoptic bronchoscopes.
timeFrame: 15 Minutes
measure: Device Complications:
timeFrame: Through study completion
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ahmed Abdalla Mohamed
Study officials:
References: