Gender Specific Differences in Postoperative Sore Throat for Ambu® AuraGain™ Laryngeal Mask (LadyLAMA)

Evaluation of Gender Specific Differences in Postoperative Sore Throat Following General Anaesthesia With Ambu® AuraGain™ Laryngeal Mask

The purpose of this study is to evaluate gender specific risk factors and the influence of cuff pressure in the occurrence of postoperative sore throat and hoarseness following general anaesthesia using Ambu® AuraGain™ Laryngeal Mask.

Study Overview

• Status: Completed
• Conditions: Postoperative Complications; Postoperative Pain
• Intervention / Treatment: Device: Ambu® AuraGain™ Laryngeal Mask (LM)

Detailed Description

The history and physical examinations of all patients scheduled for surgery are screened preoperatively for exclusion criteria. Patient recruitment is conducted by one of the study physicians. After eligibility is confirmed and written informed consent is obtained, enrolled participants are randomized depending on their gender (400 men, 400 women) in a single-blinded manner (patients) 24 hours before the intervention in a 1:1 ratio to low cuff pressure (45 cmH2O) or normal cuff pressure (60 cmH2O). Patient questioning via questionnaire is conducted in postoperative anaesthetic care unit, 24h, 48h and 72h until freedom of symptoms.

• Study Type: Interventional
• Enrollment (Actual): 814
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Rhineland-Palatine
    • Mainz, Rhineland-Palatine, Germany, 55131
      • Department of Anaesthesiology, University Medical Center of the Johannes Gutenberg-University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• elective surgery in ophthalmology under general anaesthesia with laryngeal mask
• Age > 18
• informed written consent

Exclusion Criteria:

• Anticipated difficult airway with indication for awake tracheal intubation
• Indication for RSI or elevated risk for aspiration;
• Pregnant or breastfeeding;
• Age < 18 years;
• Obesity
• Out-patient surgery (Geb. 505);
• Limited mouth opening;
• Pre-existing hoarseness and sore throat
• Participant in other studies
• Unable to provide informed written consent or under guardianship

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Women - low cuff pressure; A cuff pressure of 45 cm H2O is used to block the laryngeal mask	Device: Ambu® AuraGain™ Laryngeal Mask (LM); Depending on the gender and randomization, the LM is either blocked with 45 cmH2O or with 60 cmH2O cuff pressure. Following general anaesthesia, patients are questioned for postop complications, with focus on postoperative sore throat and hoarseness.; Other Names: Cuff pressure
Other: Men - low cuff pressure; A cuff pressure of 45 cm H2O is used to block the laryngeal mask	Device: Ambu® AuraGain™ Laryngeal Mask (LM); Depending on the gender and randomization, the LM is either blocked with 45 cmH2O or with 60 cmH2O cuff pressure. Following general anaesthesia, patients are questioned for postop complications, with focus on postoperative sore throat and hoarseness.; Other Names: Cuff pressure
Other: Women - normal cuff pressure; A cuff pressure of 60 cm H2O is used to block the laryngeal mask	Device: Ambu® AuraGain™ Laryngeal Mask (LM); Depending on the gender and randomization, the LM is either blocked with 45 cmH2O or with 60 cmH2O cuff pressure. Following general anaesthesia, patients are questioned for postop complications, with focus on postoperative sore throat and hoarseness.; Other Names: Cuff pressure
Other: Men - normal cuff pressure; A cuff pressure of 60 cm H2O is used to block the laryngeal mask	Device: Ambu® AuraGain™ Laryngeal Mask (LM); Depending on the gender and randomization, the LM is either blocked with 45 cmH2O or with 60 cmH2O cuff pressure. Following general anaesthesia, patients are questioned for postop complications, with focus on postoperative sore throat and hoarseness.; Other Names: Cuff pressure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gender specific differences in sore throat 24 hours postoperative	Comparing the incidence of postoperative sore throat between males and females within the first 24 hours after general anaesthesia with a second-generation Ambu® AuraGain™ Laryngeal Mask for elective, ophthalmological surgery	24 hours after general anaesthesia (removal of laryngeal mask)
Differences in sore throat 24 hours postoperatively in correlation to cuff pressure	Comparing the incidence of postoperative sore throat within the first 24 hours after general anaesthesia with a second-generation Ambu® AuraGain™ Laryngeal Mask for elective, ophthalmological surgery in correlation to cuff pressure (45 cmH2O and 60 cmH2O)	24 hours after general anaesthesia (removal of laryngeal mask)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Risk factors for postoperative sore throat in correlation to gender and cuff pressure	Evaluating the effect of cuff pressure (45 cmH2O vs 60 cmH2O) stratified by gender on the incidence of postoperative sore throat (%). Furthermore, incidence of postoperative sore throat and hoarseness in PACU, at 48 and 72 hours until freedom of symptoms in correlation to gender and cuff pressure. In addition, influence of gender and cuff pressure on duration of pain and pain quality (measured via a pain scale of 0 = no pain, 1 = less than a cold, 2 = like a cold, 3 = more than a cold) will be evaluated.	From end of general anaesthesia (removal of laryngeal mask) until at minimum Day 3. If symptoms persist past Day 3 postoperatively, the maximum observation period is 100 days or until freedom of symptoms (whichever comes first)

Collaborators and Investigators

• Sponsor: Johannes Gutenberg University Mainz

Publications and helpful links

General Publications

• Jaensson M, Gupta A, Nilsson U. Gender differences in sore throat and hoarseness following endotracheal tube or laryngeal mask airway: a prospective study. BMC Anesthesiol. 2014 Jul 19;14:56. doi: 10.1186/1471-2253-14-56. eCollection 2014.
• Epp K, Przybylski U, Luz C, Kriege M, Wittenmeier E, Schmidtmann I, Pirlich N. Evaluation of gender differences in postoperative sore throat and hoarseness following the use of Ambu AuraGain laryngeal mask: the randomised controlled LadyLAMA trial study protocol. BMJ Open. 2022 Jan 31;12(1):e056465. doi: 10.1136/bmjopen-2021-056465.

Study record dates

Study Major Dates

• Study Start (Actual): December 6, 2021
• Primary Completion (Actual): August 30, 2023
• Study Completion (Actual): August 30, 2023

Study Registration Dates

• First Submitted: May 21, 2021
• First Submitted That Met QC Criteria: June 4, 2021
• First Posted (Actual): June 7, 2021

Study Record Updates

• Last Update Posted (Actual): April 16, 2024
• Last Update Submitted That Met QC Criteria: April 14, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: laryngeal mask; postoperative sore throat and hoarseness (POST)
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Postoperative Complications; Pharyngitis
• Other Study ID Numbers: 13715

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No