N/A N=102 Randomized Single-blind Treatment

Safety and Efficacy of Laryngeal Mask Airways in Sinonasal Surgery

Conditions Requiring Sinonasal Surgery

Bottom Line

View on ClinicalTrials.gov: NCT02311153 ↗

Enrolled (actual)

102

Serious AEs

0.0%

Results posted

Jun 2018

Primary outcome: Primary: Number of Participants With Presence or Absence of Blood/Secretions in Trachea and Larynx Based on Soiling Score — 12; 10; 15; 21 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Mallinckrodt Endotracheal Tube (ETT) (Device); Laryseal Laryngeal mask airway (LMA) (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Vanderbilt University Medical Center
Primary completion: Jul 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Presence or Absence of Blood/Secretions in Trachea and Larynx Based on Soiling Score	12; 10; 15; 21; 15; 10	—
SECONDARY Anesthesia Time in Minutes	61; 49	—
SECONDARY Recovery Time in Minutes	34.5; 30; 37.5; 40	—
SECONDARY Presence of Laryngeal Spasm	0; 0	—
SECONDARY Post-op Pain Med Requirements	0; 0; 2; 3; 3; 8	—
SECONDARY Presence or Absence of Airway Complications	0; 0; 53; 49	—

Summary

Laryngeal mask airways (LMA) have been shown to be a safe mode of airway management when delivering general anesthesia to patients during a variety of operative procedures. LMA's have been studied in a wide range of otolaryngologic procedures, and are generally safe and accepted by both anesthesia providers and surgeons alike. This study will aim to demonstrate the safety and efficacy of LMA for airway management during sinonasal surgery by directly comparing them to endotracheal intubation in a prospective randomized single-blind study.

Eligibility Criteria

Inclusion Criteria

Adult patients (18 yo or older) undergoing elective sinonasal procedures including rhinoplasty, septoplasty, and paranasal sinus surgery estimated blood loss will be less than 300cc and the length of the procedure will be expected to last 2 hours or less
American Society of Anesthesiologists (ASA) scores 1-3
Mallampati classification 1-3

Exclusion Criteria

Currently pregnant
History of obstructive sleep apnea with history of difficulty with ventilation
Mouth opening less than 3cm
Indications for fiberoptic intubation present
Upper aerodigestive tract mass or malignancy
Procedure deemed emergent
Severe gastroesophageal reflux, severe cardiac, pulmonary, renal or hepatic co-morbidities
Unable to consent to study

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02311153). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.