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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02300337
Acronym
LTS
Enrollment
60
Registered
2014-11-25
Start date
2014-11-30
Completion date
2015-01-31
Last updated
2015-01-19

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

Conditions

Airway Morbidity

Keywords

laryngeal tube, cuff pressure, leakage, laryngeal mask

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.

Interventions

DEVICEReduce 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.

Sponsors

Johannes Gutenberg University Mainz
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Comparison of Leakage between the different Cuff Pressure< 5 MinutesWe want to measure the tightness of the reduced Cuff Pressure

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 11, 2026