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Baska mask versus Proseal laryngeal mask for reduction of laryngopharyngeal morbidity following elective surgery.

Impact of supraglottic airway device cuff pressure on the incidence of laryngopharyngeal morbidity following elective surgery under general anesthesia in young adults: Comparison of classic and Proseal laryngeal mask versus the Baska mask.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON29377
Enrollment
150
Registered
2013-04-02
Start date
2013-04-15
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients undergoing elective surgical procedure under general anesthesia with a supraglottic airway device

Interventions

Arm 1: Baska Mask Group
Arm 2: Cuffed Airway Group (PLM).

Sponsors

Ministry of Health (Oman) PO Box 393 Postcode 113 Muscat, Sultanate of Oman
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients who give informed consent; 2. Elective ambulatory surgery with an estimated duration of 30 to 60 minutes; 3. American Society of Anesthesiologists (ASA) status I-II; 4. Aged 18 to 50 years; 5. Body mass index (BMI) ≤ 35 kg/m2.

Exclusion criteria

Exclusion criteria: 1. Predictors of or a history of difficult intubation; 2. Immobilized cervical spine; 3. A history of uncontrolled gastroesophageal reflux or hiatus hernia; 4. Any pathologies of the mouth, pharynx or larynx, the access to the airway is restricted, or a difficult tracheal intubation is anticipated.

Design outcomes

Primary

MeasureTime frame
Sore throat score following the use of SADs. (Score 0 = no complaints, score 1 = minimal sore throat, score 2 = moderate sore throat, score 3 = severe sore throat: "never a SAD again").

Secondary

MeasureTime frame
1. Insertion time needed for placement of the SAD; 2. Number of attempts needed to correctly place the SAD; 3. Airway Sealing Pressure in cm H2O at 5 and 10 mins post-placement; 4. Ease of removal; 5. Blood on the device; 6. Duration for which the device remained in the oropharynx.

Contacts

Public ContactNaresh Kaul

PO Box 514

naresh.kumar@moh.gov.om

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)