search
Back to results

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

Primary Purpose

Postoperative Complications, Postoperative Pain

Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Ambu® AuraGain™ Laryngeal Mask (LM)
Sponsored by
Johannes Gutenberg University Mainz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Complications focused on measuring postoperative sore throat and hoarseness (POST), laryngeal mask

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Other

Other

Other

Other

Arm Label

Women - low cuff pressure

Men - low cuff pressure

Women - normal cuff pressure

Men - normal cuff pressure

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

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
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)

Secondary Outcome Measures

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.

Full Information

First Posted
May 21, 2021
Last Updated
July 16, 2023
Sponsor
Johannes Gutenberg University Mainz
search

1. Study Identification

Unique Protocol Identification Number
NCT04915534
Brief Title
Gender Specific Differences in Postoperative Sore Throat for Ambu® AuraGain™ Laryngeal Mask
Acronym
LadyLAMA
Official Title
Evaluation of Gender Specific Differences in Postoperative Sore Throat Following General Anaesthesia With Ambu® AuraGain™ Laryngeal Mask
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 6, 2021 (Actual)
Primary Completion Date
July 2023 (Anticipated)
Study Completion Date
July 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Johannes Gutenberg University Mainz

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Complications, Postoperative Pain
Keywords
postoperative sore throat and hoarseness (POST), laryngeal mask

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
prospective, randomized, controlled, single-blinded
Masking
Participant
Masking Description
Patients are allocated to the cuff pressure groups via block randomization
Allocation
Randomized
Enrollment
800 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Women - low cuff pressure
Arm Type
Other
Arm Description
A cuff pressure of 45 cm H2O is used to block the laryngeal mask
Arm Title
Men - low cuff pressure
Arm Type
Other
Arm Description
A cuff pressure of 45 cm H2O is used to block the laryngeal mask
Arm Title
Women - normal cuff pressure
Arm Type
Other
Arm Description
A cuff pressure of 60 cm H2O is used to block the laryngeal mask
Arm Title
Men - normal cuff pressure
Arm Type
Other
Arm Description
A cuff pressure of 60 cm H2O is used to block the laryngeal mask
Intervention Type
Device
Intervention Name(s)
Ambu® AuraGain™ Laryngeal Mask (LM)
Other Intervention Name(s)
Cuff pressure
Intervention Description
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.
Primary Outcome Measure Information:
Title
Gender specific differences in sore throat 24 hours postoperative
Description
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
Time Frame
24 hours after general anaesthesia (removal of laryngeal mask)
Title
Differences in sore throat 24 hours postoperatively in correlation to cuff pressure
Description
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)
Time Frame
24 hours after general anaesthesia (removal of laryngeal mask)
Secondary Outcome Measure Information:
Title
Risk factors for postoperative sore throat in correlation to gender and cuff pressure
Description
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.
Time Frame
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)

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
Biological gender (gender specific physiology of the Larynx)
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Katharina Epp, MD
Phone
0049 6131 17 2854
Email
katharina.epp@uniklinik-mainz.de
First Name & Middle Initial & Last Name or Official Title & Degree
Nina Pirlich, MD
Phone
0049 6131 17 2816
Email
pirlich@uni-mainz.de
Facility Information:
Facility Name
Department of Anaesthesiology, University Medical Center of the Johannes Gutenberg-University
City
Mainz
State/Province
Rhineland-Palatine
ZIP/Postal Code
55131
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katharina Epp, M.D.
Email
kathaepp@uni-mainz.de
First Name & Middle Initial & Last Name & Degree
Nina Pirlich, M.D.
Email
pirlich@uni-mainz.de

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25061426
Citation
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.
Results Reference
background
PubMed Identifier
35105650
Citation
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs