Comparison of Reduced Cuff-pressure of the Laryngeal Tube Under General Anesthesia (LTS)

Comparative Study of the Tightness of the Laryngeal Tube Under Mechanical Ventilation Before and After Reduction of Cuff Pressure on 60cmH₂O, 50cmH₂O, 40cmH₂O or 30cmH₂O

Optimization the cuff pressure of the laryngeal tube (LT) in relation of the mechanical ventilation, and the reduction of potential leakage mucosal trauma. Comparison of the tightness of LT between the filling volume specified by the manufacturer (connectors are color coded syringe and blocker), 60cmH₂O, 50cmH₂O, 40cmH₂Ound 30cmH₂O. The measurement of the leakage occurs in ml / kg body weight.

Study Overview

• Status: Completed
• Conditions: Airway Morbidity
• Intervention / Treatment: Device: Reduce Cuff pressure

Detailed Description

The ventilation of both cuffs of the laryngeal tube by using the color coding of syringe and connector is a simple, fast and easy way to stabilize the tube and secure seal against the surrounding tissue.

The user of this method has only knowledge of the volume (ml), with which the cuff is vented, but not over the cuff pressure (cmH₂O) itself.

Permanently high pressures can cause to a lesions to necrosis in the adjacent tissue, on the other hand, the material of the bulging cuff fits less well the anatomy of the patient, leading to leaks in the breathing circuit.

Studies of pediatric anesthesia show that on 40cmH₂O reduces the volume of the leak in the laryngeal mask airway by reducing the cuff pressure and the ventilation is improved in sequence.

In the proposed study, the volume of leakage at the fill volume specified by the manufacturer (color coding), 60cmH₂O, 50cmH₂O, 40cmH₂O and 30cmH₂O to be captured.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Rhineland-Palatinate
    • Mainz, Rhineland-Palatinate, Germany, D55131
      • Department of Anesthesiology,Prof. C. Werner, Universitätsmedizin of the JG University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age ≥ 18 Years
• No concurrent participation in another study
• capacity to consent
• Present written informed consent of the research participant
• Elective surgery under general anesthesia
• Height> 150cm

Exclusion Criteria:

• Age <18 years
• Existing pregnancy
• Lack of consent
• inability to consent
• emergency patients
• Emergency situations in the context of a Difficult Airway Management
• ASA classification> 3
• situations where the possibility of accumulated gastric contents
• Indications for intubation with endotracheal tube
• Height <150cm
• Participation in another study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Reduce Cuff Pressure; Cuff Pressure difference between inspiration and expiration is measured.	Device: Reduce Cuff pressure; We reduce the Cuff Pressure from the LTS-D (Laryngeal Tube suction) from 60 to 50 to 40 to 30cmH2O and measure the Delta from Inspiration to Expiration Tidalvolume (Delta Vt). The Delta Vt shows the actual leakage.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of Leakage between the different Cuff Pressure	We want to measure the tightness of the reduced Cuff Pressure	< 5 Minutes

Collaborators and Investigators

• Sponsor: Johannes Gutenberg University Mainz
• Investigators: Principal Investigator: Rüdiger Noppens, MD, University JG, Mainz

Publications and helpful links

General Publications

• Janig C, Marquardt S, Dietze T, Nitsche T. Laryngeal tube placement on manikin by laypersons: is there a possibility for 'public access airway management'? Eur J Emerg Med. 2014 Feb;21(1):65-8. doi: 10.1097/MEJ.0b013e328364a152.
• Kriege M, Alflen C, Eisel J, Ott T, Piepho T, Noppens RR. Evaluation of the optimal cuff volume and cuff pressure of the revised laryngeal tube "LTS-D" in surgical patients. BMC Anesthesiol. 2017 Feb 2;17(1):19. doi: 10.1186/s12871-017-0308-4.

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (Actual): January 1, 2015
• Study Completion (Actual): January 1, 2015

Study Registration Dates

• First Submitted: November 20, 2014
• First Submitted That Met QC Criteria: November 24, 2014
• First Posted (Estimate): November 25, 2014

Study Record Updates

• Last Update Posted (Estimate): January 19, 2015
• Last Update Submitted That Met QC Criteria: January 16, 2015
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Keywords: laryngeal mask; leakage; cuff pressure; laryngeal tube
• Other Study ID Numbers: JohannesGU