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

NCT ID: NCT04915534

Last Updated: 2024-04-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 814 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-06
• Study Completion Date: 2023-08-30

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.

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.

Conditions

Postoperative Complications; Postoperative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Women - low cuff pressure

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

Group Type: OTHER

Ambu® AuraGain™ Laryngeal Mask (LM)

Intervention Type: 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.

Men - low cuff pressure

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

Group Type: OTHER

Ambu® AuraGain™ Laryngeal Mask (LM)

Intervention Type: 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.

Women - normal cuff pressure

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

Group Type: OTHER

Ambu® AuraGain™ Laryngeal Mask (LM)

Intervention Type: 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.

Men - normal cuff pressure

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

Group Type: OTHER

Ambu® AuraGain™ Laryngeal Mask (LM)

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

Cuff pressure

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Johannes Gutenberg University Mainz

OTHER

Sponsor Role: lead

Responsible Party

Katharina Epp

Dr.med. Katharina Epp

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Mainz, Rhineland-Palatine, Germany

Countries

Germany

References

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.

Reference Type: BACKGROUND

PMID: 25061426 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 35105650 (View on PubMed)

Other Identifiers

13715

Identifier Type: -

Identifier Source: org_study_id