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

Airway Morbidity Clinical Trial

— LTS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02300337
• Other study ID #: JohannesGU
• Status: Completed
• Phase: N/A
• First received: November 20, 2014
• Last updated: January 16, 2015
• Start date: November 2014
• Est. completion date: January 2015

Study information

• Verified date: January 2015
• Source: Johannes Gutenberg University Mainz
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Airway Morbidity

Intervention

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.

Locations

Country	Name	City	State
Germany	Department of Anesthesiology,Prof. C. Werner, Universitätsmedizin of the JG University	Mainz	Rhineland-Palatinate

Sponsors (1)

Lead Sponsor	Collaborator
Johannes Gutenberg University Mainz

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Jänig 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of Leakage between the different Cuff Pressure	We want to measure the tightness of the reduced Cuff Pressure	< 5 Minutes	No