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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified October 2012 by The University of Hong Kong
Sponsor:
Information provided by (Responsible Party):
The University of Hong Kong
ClinicalTrials.gov Identifier:
NCT01709890
First received: October 16, 2012
Last updated: October 29, 2012
Last verified: October 2012
  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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: The University of Hong Kong
ClinicalTrials.gov Identifier: NCT01709890     History of Changes
Other Study ID Numbers: SZENG1.0
Study First Received: October 16, 2012
Last Updated: October 29, 2012
Health Authority: Hong Kong: Ethics Committee

ClinicalTrials.gov processed this record on July 28, 2014