Patients Undergoing Anesthesiologist-administered iv Sedation During Diagnostic/ Therapeutic ProceduresNCT01709890
Evaluation of a New Airway Device - the YO2(R) Catheter in Patients Under Sedation
An observational study of Patients Undergoing Anesthesiologist-administered iv Sedation During Diagnostic/ Therapeutic Procedures, run by The University of Hong Kong at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Patients Undergoing Anesthesiologist-administered iv Sedation During Diagnostic/ Therapeutic Procedures
- What is being tested?
- YO2(R) catheter
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- Dec 2012to not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing anesthesiologist-administered sedation for diagnostic/ therapeutic procedures
Who may be able to join
- Adult patient, age >18 and <80
- Undergoing anesthesiologist-administered sedation for diagnostic/ therapeutic procedures
Who cannot join
- Expected procedure require access to or involve the nostrils.
- Obesity (BMI >=30)
- Chronic lung diseases (e.g. COPD) associated with chronic hypoxia
- Pregnant or lactating women.
- Known chronic liver or renal disease.
- Mentally incapable of providing informed consent
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Anaesthesiology, The University of Hong Kong
Hong Kong, Hong Kong, HKSAR
Kwok F.J. Ng, MBChB, MD, FANZCA, FHKAM, +852 22553303, jkfng@hku.hk
About this study
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.
- Being tested
- YO2(R) catheter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YO2(R) catheterDevice
| Study group | Role | What they receive |
|---|---|---|
| Airway catheter during sedation | Not described Receives: Device: YO2(R) catheter |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2012 (estimated)
- Study startDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients Undergoing Anesthesiologist-administered iv Sedation During Diagnostic/ Therapeutic ProceduresStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01709890
- Sponsor's protocol ID
- SZENG1.0
- Status last verified
- Oct 2012
- First submitted
- 16 Oct 2012
- Last updated
- 31 Oct 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a New Airway Device - the YO2(R) Catheter in Patients Under Sedation
- ClinicalTrials.gov ID
- NCT01709890
- Acronym / sponsor ID
- SZENG1.0
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- Dec 2012
- First posted
- 18 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Airway catheter during sedation | – | Device: YO2(R) catheter |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing anesthesiologist-administered sedation for diagnostic/ therapeutic procedures
Key inclusion criteria (2 listed)
- Adult patient, age >18 and <80
- Undergoing anesthesiologist-administered sedation for diagnostic/ therapeutic procedures
Key exclusion criteria (6 listed)
- Expected procedure require access to or involve the nostrils.
- Obesity (BMI >=30)
- Chronic lung diseases (e.g. COPD) associated with chronic hypoxia
- Pregnant or lactating women.
- Known chronic liver or renal disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| YO2(R) catheter | Device | Airway catheter during sedation |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2012.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patients Undergoing Anesthesiologist-administered iv Sedation During Diagnostic/ Therapeutic Procedures, run by The University of Hong Kong at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kwok F.J. Ng, MBChB, MD, FANZCA, FHKAM (+852 22553303, jkfng@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2012.