Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00500916
Other study ID # UN2532
Secondary ID
Status Completed
Phase N/A
First received July 11, 2007
Last updated December 3, 2007
Start date March 2007
Est. completion date December 2007

Study information

Verified date December 2007
Source Medical University Innsbruck
Contact n/a
Is FDA regulated No
Health authority Austria: Federal Ministry for Health and Women
Study type Interventional

Clinical Trial Summary

The ProSeal laryngeal mask airway (PLMA) is a new laryngeal mask device with a modified cuff to improve the seal and a drain tube to prevent aspiration and gastric insufflation. The manufacturer recommends inserting the PLMA using digital manipulation, like the Classic LMA, or with an introducer tool (IT), like the Intubating LMA. The mean (range) frequency of insertion success at the first attempt for these techniques is 84% (81-100) and 95% (90-100) respectively, with the main causes of insertion difficulty being impaction at the back of the mouth and failure of the distal cuff to reach the hypopharynx. Howarth et al described an insertion technique which overcomes these difficulties by using a gum elastic bougie (GEB) placed in the esophagus to guide the PLMA around the back of the mouth and into its correct position in the hypopharynx. Howarth et al reported no failed uses from 100 consecutive insertions. In the following study, we test the hypothesis that GEB-guided insertion is more frequently successful than the digital and IT techniques in patients with difficult airway.


Recruitment information / eligibility

Status Completed
Enrollment 0
Est. completion date December 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Female
Age group 19 Years to 70 Years
Eligibility Inclusion Criteria:

- Female patient

- 19-70 yr

- Body mass index <35 kg/m2

- Difficult airway

Exclusion Criteria:

- < 19 yr

- Body mass index >35 kg/m2

- Risk of aspiration

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Device:
ProSeal LMA
GEB vs digital vs introducer tool

Locations

Country Name City State
Austria Department of Anesthesia and Intensive Care Innsbruck

Sponsors (1)

Lead Sponsor Collaborator
Medical University Innsbruck

Country where clinical trial is conducted

Austria, 

Outcome

Type Measure Description Time frame Safety issue
Primary Insertion success rate 5 min No
Secondary Time to successful insertion 5 min No
See also
  Status Clinical Trial Phase
Recruiting NCT06063798 - Respiratory Effects of Flow-Controlled Ventilation and Jet Ventilation in Patients Undergoing Laryngotracheal Surgery N/A
Completed NCT03657368 - Ventilation Strategy During General Anesthesia for Orthopedic Surgery N/A
Completed NCT02943863 - Regional Ventilation During High Flow Nasal Cannula and Conventional Nasal Cannula in Patients With Hypoxia N/A
Completed NCT01056939 - Neurally Adjusted Ventilatory Assist (NAVA) in Pediatric Patients N/A
Completed NCT03287752 - BASKA Mask Versus Endo Tracheal Tube in Gynecological Laparoscopic Surgery
Completed NCT00779090 - Functional Residual Capacity (FRC) Guided Alveolar Recruitment Strategy Phase 4
Completed NCT04014920 - Non-invasive Ventilation Following Extubation (Prophylactic) to Prevent Extubation Failure in Critically Obese Patients N/A
Completed NCT04281589 - End-tidal Carbon Dioxide Monitoring in Low Tidal Volume Ventilation N/A
Completed NCT02751047 - Manual Ventilation Versus Pressure Controlled Mechanical Ventilation in Children N/A
Completed NCT03139448 - Comparison of Oxygenation and Ventilation With a Novel Nasal Mask Versus Standard of Care During Colonoscopy N/A
Recruiting NCT05823688 - Electrical Impedance Tomography (EIT) Monitoring of Regional Ventilation During Pediatric Laparoscopy
Recruiting NCT03106974 - A Comparison of Tracheal Intubation Using the Totaltrack vs the Macintosh Laryngoscope in Obese Patients N/A
Completed NCT03996161 - Effect of Semi-sitting Position on Mask Ventilation N/A
Completed NCT03083379 - Pilot Evaluation Comparing Regional Distribution of Ventilation During Lung Expansion Therapy N/A
Completed NCT05523752 - Insertion of Different Supraglottic Airway Devices on Manikin N/A
Completed NCT00919971 - Bispectral Index (BIS) on Ventilated Patients in the Prehospital Setting N/A
Completed NCT05388266 - Effect of Paratracheal Pressure on Mask Ventilation N/A
Completed NCT03368352 - Effects of Melatonin on Sleep, Ventilatory Control and Cognition at Altitude. Early Phase 1
Completed NCT01168557 - Stress Echo and Electric Impedance Tomography (EIT) Pilot Study N/A
Completed NCT01053455 - Observational Crossover Study Comparing Oxygenation and Ventilation Using SiPAP Versus CPAP in LBW Infants N/A