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Evaluation of a New Airway Device - the YO2(R) Catheter in Patients Under Sedation

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2012 by The University of Hong Kong.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01709890
First Posted: October 18, 2012
Last Update Posted: October 31, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
The University of Hong Kong
  Purpose
Patients under sedation not uncommonly develop upper airway obstruction or other respiratory complications and no airway device is available to provide reliable maintenance of the airway at present. I believe the YO2(R)airway catheter can improve the maintenance of patent airway in most sedated patients and improve O2 delivery to the airway. In addition it may also greatly facilitate the monitoring of expired CO2, which is widely recognised as the most important monitor of adequacy of breathing, yet frequently impossible to perform satisfactorily in sedated patients at the moment.

Condition Intervention
Patients Undergoing Anesthesiologist-administered iv Sedation During Diagnostic/ Therapeutic Procedures Device: YO2(R) catheter

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Further study details as provided by The University of Hong Kong:

Estimated Enrollment: 50
Study Start Date: December 2012
Groups/Cohorts Assigned Interventions
Airway catheter during sedation Device: YO2(R) catheter

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoing anesthesiologist-administered sedation for diagnostic/ therapeutic procedures
Criteria

Inclusion Criteria:

  1. Adult patient, age >18 and <80
  2. Undergoing anesthesiologist-administered sedation for diagnostic/ therapeutic procedures

Exclusion Criteria:

  1. Expected procedure require access to or involve the nostrils.
  2. Obesity (BMI >=30)
  3. Chronic lung diseases (e.g. COPD) associated with chronic hypoxia
  4. Pregnant or lactating women.
  5. Known chronic liver or renal disease.
  6. Mentally incapable of providing informed consent
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01709890


Contacts
Contact: Kwok F.J. Ng, MBChB, MD, FANZCA, FHKAM +852 22553303 jkfng@hku.hk

Locations
China, Hong Kong
Department of Anaesthesiology, The University of Hong Kong Not yet recruiting
Hong Kong, Hong Kong, China, HKSAR
Contact: Kwok F.J. Ng, MBChB, MD, FANZCA, FHKAM    +852 22553303    jkfng@hku.hk   
Sponsors and Collaborators
The University of Hong Kong
  More Information

Responsible Party: The University of Hong Kong
ClinicalTrials.gov Identifier: NCT01709890     History of Changes
Other Study ID Numbers: SZENG1.0
First Submitted: October 16, 2012
First Posted: October 18, 2012
Last Update Posted: October 31, 2012
Last Verified: October 2012


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