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

NCT ID: NCT02300337

Last Updated: 2015-01-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-30
• Study Completion Date: 2015-01-31

Brief 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.

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.

Conditions

Airway Morbidity

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Reduce Cuff Pressure

Cuff Pressure difference between inspiration and expiration is measured.

Group Type: EXPERIMENTAL

Reduce Cuff pressure

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johannes Gutenberg University Mainz

OTHER

Sponsor Role: lead

Responsible Party

Marc Kriege

Marc Kriege,MD, Rüdiger Noppens, MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rüdiger Noppens, MD

Role: PRINCIPAL_INVESTIGATOR

University JG, Mainz

Locations

Department of Anesthesiology,Prof. C. Werner, Universitätsmedizin of the JG University

Mainz, Rhineland-Palatinate, Germany

Countries

Germany

References

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.

Reference Type: RESULT

PMID: 23887642 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 28152975 (View on PubMed)

Other Identifiers

JohannesGU

Identifier Type: -

Identifier Source: org_study_id