Anesthesia; Functional Clinical Trial
Official title:
The Air-Q Intubating Laryngeal Airway Versus the LMA-Proseal: A Prospective, Randomized Trial of Airway Seal Pressure
Verified date | July 2012 |
Source | University of Wisconsin, Madison |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
Introduction:
The air-QⓇ Intubating Laryngeal Airway (ILA) is a newer supraglottic airway. It is approved
for use as a primary airway and as an aid for intubation in situations of anticipated or
unanticipated difficult airways. A unique feature of this device as compared to other
airways on the market is the size of the inner diameter (ID) and length of its airway tube.
Direct placement of tracheal tubes > 7.5 mm ID through the airway tube is possible.
The ProSealTM LMA is considered the gold standard for supraglottic devices with respect to
airway seal pressure. On average, it is reported to be approximately 28 cmH2O. This is
significantly higher than that of the first generation LMA, the LMA-ClassicTM, which has a
maximum seal pressure of 20 cmH2O, but averages 16-18 cmH2O in actual practice.
In this study the investigators aim to test whether the air-QⓇ creates an airway seal
pressure that is similar to the LMA-ProSealTM, whether the position of the air-QⓇ in
relation to the vocal cords, as assessed by fiberoptic endoscopy, is similar to that of the
LMA-ProSealTM and whether airway morbidity is similar between the air-QⓇ and the
LMA-ProSealTM.
Status | Completed |
Enrollment | 100 |
Est. completion date | April 2010 |
Est. primary completion date | April 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patients who are 18 years or greater may be included if they presenting for any elective surgery or procedure to take place in any anesthetic location and require placement of a LMA for their surgery or procedure. Exclusion Criteria: - non-English speaking - pregnant - are a minor - are a prisoner - have impaired decision-making capacity or any condition for which the primary anesthesia team deems intubation with a tracheal tube to be necessary |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
United States | University of Wisconsin School of Medicine and Public Health | Madison | Wisconsin |
Lead Sponsor | Collaborator |
---|---|
University of Wisconsin, Madison |
United States,
Cook TM, Lee G, Nolan JP. The ProSeal laryngeal mask airway: a review of the literature. Can J Anaesth. 2005 Aug-Sep;52(7):739-60. Review. — View Citation
Wong DT, McGuire GP. Endotracheal intubation through a laryngeal mask/supraglottic airway. Can J Anaesth. 2007 Jun;54(6):489-91; author reply 491. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Airway Seal Pressure | The airway seal pressure will then be assessed by closing the APL valve on the anesthesia machine with a fresh gas flow of 5 liters/minute until an audible leak is observed. | Intraoperative (day 1) | Yes |
Secondary | Grossly Visible Blood or Bile on LMA | At the conclusion of the case, when the patient is breathing on their own and is awake enough, as judged by the anesthesia provider, the LMA will be removed, as would be otherwise done as standard of care. The study LMA will be examined by a data collector for the presence of grossly visible blood or bile, and its presence or absence will be recorded. | Upon LMA removal | Yes |
Secondary | Glottic View | Once the LMA has been placed and secured and the patient is stable from an anesthetic point of view, a flexible fiberoptic camera will be place into the airway tube of the LMA and the view of the patient's vocal cords in relation to the cuff of the LMA will be assessed. | Intraoperative (day 1) | No |
Secondary | Airway Pathology | In the recovery area, once the patient is fully awake, as judged by the recovery staff, an observer will administer a standard oral questionnaire to the patient to determine if a sore throat is present. | Postoperative (day 1) in recovery room | Yes |
Secondary | Airway Pathology | The patient will be called 24 hours later by the data collector who will administer a standard oral questionnaire to the patient to determine if a sore throat is present. | Postoperative Day Two | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02012257 -
Success Rate of Anterior Middle Superior Alveolar (AMSA) Nerve Block in Three Different Sites of Injection
|
N/A | |
Not yet recruiting |
NCT05525351 -
The Application and Validation of Triple Drug Response Surface Models on Density Spectral Array in Clinical Anesthesia
|
||
Not yet recruiting |
NCT02937337 -
Laryngeal Mask Airway With Video-stylet
|
N/A | |
Recruiting |
NCT03786211 -
IANB Success Rate With and Without Panoramic Help
|
Phase 2/Phase 3 | |
Completed |
NCT03874403 -
Anesthetic Component Research on VATS and NIVATS
|
N/A | |
Recruiting |
NCT04376307 -
Minimal Flow Application in One Lung Ventilation
|
N/A | |
Completed |
NCT03533452 -
The Impact of a Preoperative Nerve Block on the Consumption of Sevoflurane
|
Phase 2/Phase 3 | |
Completed |
NCT03386630 -
Effects of Analgesics in Cesarean Section Elective
|
Phase 4 | |
Completed |
NCT05404269 -
AGC Mode vs Minimal Flow in Breast Surgery
|
||
Recruiting |
NCT05603442 -
Thoracic Intervertebral Foramen Block
|
N/A | |
Recruiting |
NCT05754515 -
Evaluation of Oxygenation Parameters in Patients Undergoing Rhinoplasty Under General Anesthesia
|
||
Completed |
NCT02455921 -
Neuromuscular Blockade Reversal Agent Effect on Postoperative Cognitive Function and Behaviour in Children
|
Phase 4 | |
Completed |
NCT03480165 -
The Efficacy of 20 mg Parecoxib as an Adjunct to 0.75% Ropivacaine in Supraclavicular Brachial Plexus Block for Upper Limb Surgery
|
Phase 3 | |
Completed |
NCT03140982 -
Is Anesthetic Loss of Consciousness a Top Down or Bottom up Phenomenon. What Does the Neurologic Examination Say?.
|
N/A | |
Completed |
NCT03486106 -
Music Distraction and Its Influence on Anesthetic Requirements During Elective Knee Surgery
|
N/A | |
Completed |
NCT03021421 -
Comparison of Two Regional Technics In Knee Artroplasty
|
Phase 0 | |
Completed |
NCT06249113 -
Effectiveness of Continous Adjuvant Lidocaine on General Anaesthesia on Tumor Craniotomy Surgery
|
N/A | |
Completed |
NCT03438253 -
Unwanted Penile Engorgement in Pediatric Patients Under Anesthesia.
|
N/A | |
Completed |
NCT03913858 -
Low Flow Anesthesia in Morbid Obesity
|
N/A | |
Completed |
NCT04813952 -
The Effect of Minimal Flow Sevoflurane Anesthesia
|
N/A |