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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT01709890
Other study ID # SZENG1.0
Secondary ID
Status Not yet recruiting
Phase N/A
First received October 16, 2012
Last updated October 29, 2012
Start date December 2012

Study information

Verified date October 2012
Source The University of Hong Kong
Contact Kwok F.J. Ng, MBChB, MD, FANZCA, FHKAM
Phone +852 22553303
Email jkfng@hku.hk
Is FDA regulated No
Health authority Hong Kong: Ethics Committee
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 50
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms

  • Patients Undergoing Anesthesiologist-administered iv Sedation During Diagnostic/ Therapeutic Procedures

Intervention

Device:
YO2(R) catheter


Locations

Country Name City State
China Department of Anaesthesiology, The University of Hong Kong Hong Kong Hong Kong

Sponsors (1)

Lead Sponsor Collaborator
The University of Hong Kong

Country where clinical trial is conducted

China,