ProSeal Laryngeal Mask Airway (LMA) Size 3 vs 4 in Non-paralyzed Female Patients

Comparison of the Size 3 ProsealTM Laryngeal Mask Airway Versus Size 4 in Anaesthetized, Non-paralyzed Women: A Randomised Controlled Trial

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01184677

Enrollment

154

Registered

2010-08-19

Start date

2010-08-31

Completion date

2012-02-29

Last updated

2012-08-27

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

Conditions

Oropharyngeal Injury

Brief summary

The investigators hypothesize that ProSeal laryngeal mask airway (PLMA) of smaller size would reduce the incidence of mucosal injury.

Detailed description

The ProSealTM laryngeal mask airway (PLMA; Laryngeal Mask Co. Limited, Mahe, Seychelles) is a laryngeal mask device with an added dorsal cuff to improve the seal and a drainage tube to prevent aspiration and gastric insufflations(Brain, Verghese et al. 2000).Despite its utility, there are complications associated with PLMA insertion such as sore throat and mucosal injury including oropharyngeal blood. The purpose of this randomized controlled study is to determine if size 3 PLMA would induce less mucosal damage indicated by blood on the cuff than size 4 in non-paralyzed female patients. The secondary objective of this study is to compare insertion time, number of attempts, oropharyngeal leak pressure, hemodynamic variables, and incidence of complications with size 3 and 4 PLMA.

Interventions

DEVICEinsertion of the ProSeal LMA (PLMA)

ProSeal LMA size 3 is inserted to the patients of Group size 3.

DEVICEinsertion of the PLMA

ProSeal LMA size 4 is inserted to the patients of Group size 4.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

* female * aged 18-80 yr * American Society of Anesthesiologists physical status Ⅰ-Ⅱ * scheduled to undergo short outpatient gynecological procedures using ProSealTM LMA (PLMA) for anesthesia

Exclusion criteria

* a known or predicted difficult airway * recent sore throat * mouth opening less than 2.5 cm * body mass index \> 35 kg/m2 * at risk of aspiration.

Design outcomes

Primary

Measure	Time frame	Description
blood on the ProSeal LMA	from the start of ProSeal LMA insertion until the end of the anesthesia (around 30min , mostly less than 60min)	The incidence of blood on the proseal LMA upon removal of the device is assessed in each group.

Secondary

Measure	Time frame	Description
hemodynamic variables	from induction of anesthesia until immediately after the Proseal LMA insertion	mean arterial pressure and heart rate before and after the Proseal LMA insertion are measured.
insertion time	from grasping the Proseal LMA until an effective airway is established	—
seal pressure	after successful insertion of Proseal LMA	oropharyngeal leak pressure
other intraoperative complications	from successful insertion of PLMA until the end of the anesthesia	airway leak, failed ventilation, regurgitation/aspiration, laryngospasm, cough/gag/retching/hiccup.
postoperative complications	from removal of Proseal LMA until discharge from recovery room	sore throat and hoarseness

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026