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

NCT ID: NCT01709890

Last Updated: 2012-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Airway catheter during sedation

YO2(R) catheter

Intervention Type DEVICE

Interventions

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YO2(R) catheter

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Department of Anaesthesiology, The University of Hong Kong

Hong Kong, Hong Kong, China

Site Status

Countries

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China

Central Contacts

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Kwok F.J. Ng, MBChB, MD, FANZCA, FHKAM

Role: CONTACT

Phone: +852 22553303

Email: [email protected]

Facility Contacts

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Kwok F.J. Ng, MBChB, MD, FANZCA, FHKAM

Role: primary

Other Identifiers

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SZENG1.0

Identifier Type: -

Identifier Source: org_study_id