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

NCT02300337 | Completed

• 1 other identifier: JohannesGU
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Airway Morbidity

Keywords

laryngeal tube; cuff pressure; leakage; laryngeal mask

Outcome Measures

Primary Outcomes (1)

• Comparison of Leakage between the different Cuff Pressure

  We want to measure the tightness of the reduced Cuff Pressure

  < 5 Minutes

Study Arms (1)

Reduce Cuff Pressure

EXPERIMENTAL

Cuff Pressure difference between inspiration and expiration is measured.

Device: Reduce Cuff pressure

Interventions

Reduce Cuff pressure 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.

Reduce Cuff Pressure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johannes Gutenberg University Mainz: lead

Study Sites (1)

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

Mainz, Rhineland-Palatinate, D55131, Germany

Location

Related Publications (2)

• 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.

  PMID: 23887642 RESULT

• 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.

  PMID: 28152975 DERIVED

Study Officials

• Rüdiger Noppens, MD

  University JG, Mainz

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Marc Kriege,MD, Rüdiger Noppens, MD

Study Record Dates

• First Submitted: November 20, 2014
• First Posted: November 25, 2014
• Study Start: November 1, 2014
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: January 19, 2015

Record last verified: 2015-01

Locations

DE (1)