Supraglottic Airway Devices and effect on phonation - comparison of Proseal LMA and I-gel airway

ASA 1 adults undergoing elective procedures with airway secured by either PLMA or I-gel airway and post-operative phonatory changes

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12613000719730

Enrollment

Registered

2013-07-01

Start date

2010-08-02

Completion date

2012-06-04

Last updated

2020-01-13

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

Conditions

None listed

Brief summary

Background: Nerve palsies with Proseal laryngeal mask airway (PLMA) are attributed to nerve compression by the inflated cuff. Cuffless anatomically pre-shaped sealers like I–gel airway (IGA) may minimize nerve compression. Materials and methods: Ninety ASA1 adults scheduled for surgeries lasting up to 60 to 120 min were included in the study. Participants were randomly allocated to group PLMA (n=43) and group IGA (n=43). Vocal cord function was evaluated by strobolaryngoscopy, perceptive and phonetic analysis of voice (Jitter, Shimmer and Harmonic to Noise Ratio) preoperatively and 24 hours after surgery. Voice of patients with pharyngolaryngeal complaints was categorized into rough, breathy, asthenic, strain or normal pattern. Results: Jitter (p<0.002), Shimmer (p<0.000) and Harmonic to noise ratio deteriorated significantly in both groups albeit the change being similar in both groups. Incidence of pharyngolaryngeal complaints was 20% and 22.5% in group PLMA and IGA respectively. 10% patients in group PLMA and 12.5% in group IGA developed breathy voice and demonstrated significant deterioration in all phonetic variables. Vocal fold anomalies on stroboscopy were detected in 2 patients in each group. Conclusion: PLMA and IGA both produce significant deterioration in phonetic variables suggesting vocal cord dysfunction after 1 – 2 hours of anaesthesia.

Interventions

Placement of Supraglottic Airway Devices - either I-gel or Proseal LMA under anaesthesia. Pre and Post operative strobolaryngoscopy and phonetic analysis of voice I-gel is a newly introduced supraglottic airway device, classified as a cuff less pharyngeal sealer. After administration of general anesthesia and muscle relaxation, airway is placed in oropharynx with tip resting in the upper esophageal sphincter. Square wave capon gram and effective chest raise confirms satisfactory placement.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Blinded (masking used) (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

Adults belonging to ASA 1 & 2 physical status undergoing surgeries for 60-120 min under general anaesthesia

Exclusion criteria

Head and neck surgeries, surgeries lasting >120 min, anticipated difficult airway, preoperative abnormality in voice

Outcome results