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Comparison of two different strategies to control the intra-cuff pressure during laryngeal mask anaesthesia - digital palpation technique versus continuous cuff pressure measurement

Comparison of two different strategies to control the intra-cuff pressure during laryngeal mask anaesthesia - digital palpation technique versus continuous cuff pressure measurement - LMA

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00008719
Enrollment
180
Registered
2015-07-03
Start date
2015-08-01
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

The participants of the study will be recruited consecutively from patients undergoing elective surgery under general anesthesia using a laryngeal mask. Medical specialities: surgery, orthopedic surgery, gynecology, plastic surgery

Interventions

Group 1: Group 1 (Digital palpation technique) LMAs will be inflated by applying the air volume recommended by the manufacturer (i.e. 20 ml size III, 30 ml size IV and 40 ml size V). Females below 50

Sponsors

Park-Klinik WeissenseeAbteilung Anästhesiologie Intensivmedizin
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients undergoing elective surgery under laryngeal mask anaesthesia Minimum age of 18 years ASA-classification I-III Good knowledge of German for understanding

Exclusion criteria

Exclusion criteria: Lack of willingness to accept storage and transfer of pseudonymised health data Emergency surgery Pregnancy Inoperable regarding the ASA-classification All operation procedures not suited for laryngeal mask anaesthesia Lack of an informed consent Age under 18 years Participation in an other study during the last three month Mental disorders

Design outcomes

Primary

MeasureTime frame
Frequency and severity of sore throats (acquired by postoperative questionnaire) Modified external quality assurance questionnaire EQS Hamburg for anesthesia. The survey will be conducted on the discharge day of the patients.

Secondary

MeasureTime frame
Frequency and severity of hoarseness (p.o. questionnaire, Modified and evaluated Hamburg EQS-questionnaire, conducted on discharge day) Frequency and severity of dysphagia (p.o. questionnaire, Modified and evaluated Hamburg EQS-questionnaire, conducted on discharge day) Duration of afflictions (p.o. questionnaire) Quality of airway (intraoperative evaluation, 10 minutes after induction of anesthesia) Inflated air volume (postoperative evaluation, at the end of operation procedure) Maximum cuff pressure (postoperative evaluation, at the end of operation procedure) Accordance between measured and estimated value (postoperative evaluation, at the end of operation procedurs). All measurements as well as documentation will be performed by an independent investigator

Countries

Germany

Contacts

Public ContactMario Hensel

Park-Klinik Weissensee

hensel@park-klinik.com0049 30 9628 3502

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026