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

NCT04915534 | Completed

• 1 other identifier: 13715
• Study Type: interventional
• Target: 814
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postoperative Complications; Postoperative Pain

Keywords

postoperative sore throat and hoarseness (POST); laryngeal mask

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Risk factors for postoperative sore throat in correlation to gender and cuff pressure

  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)

Study Arms (4)

Women - low cuff pressure

OTHER

A cuff pressure of 45 cm H2O is used to block the laryngeal mask

Device: Ambu® AuraGain™ Laryngeal Mask (LM)

Men - low cuff pressure

OTHER

A cuff pressure of 45 cm H2O is used to block the laryngeal mask

Device: Ambu® AuraGain™ Laryngeal Mask (LM)

Women - normal cuff pressure

OTHER

A cuff pressure of 60 cm H2O is used to block the laryngeal mask

Device: Ambu® AuraGain™ Laryngeal Mask (LM)

Men - normal cuff pressure

OTHER

A cuff pressure of 60 cm H2O is used to block the laryngeal mask

Device: Ambu® AuraGain™ Laryngeal Mask (LM)

Interventions

Ambu® AuraGain™ Laryngeal Mask (LM) DEVICE

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.

Also known as: Cuff pressure

Men - low cuff pressure; Men - normal cuff pressure; Women - low cuff pressure; Women - normal cuff pressure

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Biological gender (gender specific physiology of the Larynx)
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johannes Gutenberg University Mainz: lead

Study Sites (1)

Department of Anaesthesiology, University Medical Center of the Johannes Gutenberg-University

Mainz, Rhineland-Palatine, 55131, Germany

Location

Related Publications (2)

• 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.

  PMID: 25061426 BACKGROUND

• 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.

  PMID: 35105650 DERIVED

MeSH Terms

Conditions

Postoperative Complications; Pain, Postoperative; Hoarseness

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Voice Disorders; Laryngeal Diseases; Respiratory Tract Diseases; Respiration Disorders; Otorhinolaryngologic Diseases; Nervous System Diseases; Signs and Symptoms, Respiratory

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patients are allocated to the cuff pressure groups via block randomization
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.med. Katharina Epp

Model Details: prospective, randomized, controlled, single-blinded

Study Record Dates

• First Submitted: May 21, 2021
• First Posted: June 7, 2021
• Study Start: December 6, 2021
• Primary Completion: August 30, 2023
• Study Completion: August 30, 2023
• Last Updated: April 16, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)