Respiratory Rate ChangesNCT01120951
Clinical Assessment of the Use of the R8 Respiratory Rate Counter in Post-Operative Recovery in Adults and Adolescents
An observational study of Respiratory Rate Changes, run by Anaxsys Technology Ltd at 4 sites in United Kingdom.
Trial summary
The study aims to to establish whether or not measurement of respiratory rate taken using the Anaxsys Technology Ltd Respiratory Counter (R8 Counter) are equivalent to manual respiratory rate counting methods in patients receiving oxygen via a face mask. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Respiratory Rate Changes
- How many people
- 220 participants
- Where
- 4 sitesUnited Kingdom
- Study dates
- Jan 2010to Apr 2010
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Male or female patients aged 12 years and above following elective surgery under general anaesthesia
Who may be able to join
- Male or female patients aged 12 years and above following elective surgery under general anaesthesia
Who cannot join
- Patients admitted for emergency surgery
- Patients having ASA rating of 3 or greater
- Patients not receiving general anaesthesia
- Patients expected to be in post-operative recovery for less than 15 minutes
Trial locations and contacts
4 sites in 1 country.
United Kingdom4 sites
Papworth Hospital NHS Foundation Trust
Cambridge, Cambridgeshire, CB23 3RE
Russells Hall Hospital
Dudley, West Midlands, DY1 2HQ
St. Peter's and Ashford Hospital NHS Trust
Guildford, Surrey, KT16 0PZ
University Hospital of North Staffordshire
Stoke-on-Trent, Staffordshire, ST4 6QG
About this study
The study aims to to establish whether or not measurement of respiratory rate taken using the Anaxsys Technology Ltd Respiratory Counter (R8 Counter) are equivalent to manual respiratory rate counting methods in patients receiving oxygen via a face mask.
- Conditions
- Respiratory Rate Changes
- Keywords
- Respiratory rate R8 Anaxsys
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2010 (estimated)
- Study startJan 2010
- Primary completionApr 2010
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Rate ChangesStudies of the same condition, open and under way.
- 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
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anaxsys Technology Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01120951
- Sponsor's protocol ID
- ATL01009
- Status last verified
- May 2010
- First submitted
- 9 May 2010
- Last updated
- 18 May 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Assessment of the Use of the R8 Respiratory Rate Counter in Post-Operative Recovery in Adults and Adolescents
- ClinicalTrials.gov ID
- NCT01120951
- Acronym / sponsor ID
- ATL01009
- Conditions
- Respiratory Rate Changes
- Keywords
- Respiratory rate R8 Anaxsys
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Anaxsys Technology LtdIndustry (pharma, biotech, devices)
- Study start
- Jan 2010
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 11 May 2010 (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.
The study aims to to establish whether or not measurement of respiratory rate taken using the Anaxsys Technology Ltd Respiratory Counter (R8 Counter) are equivalent to manual respiratory rate counting methods in patients receiving oxygen via a face mask.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Male or female patients aged 12 years and above following elective surgery under general anaesthesia
Key inclusion criteria (1 listed)
- Male or female patients aged 12 years and above following elective surgery under general anaesthesia
Key exclusion criteria (4 listed)
- Patients admitted for emergency surgery
- Patients having ASA rating of 3 or greater
- Patients not receiving general anaesthesia
- Patients expected to be in post-operative recovery for less than 15 minutes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2010.
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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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Rate Changes, run by Anaxsys Technology Ltd at 4 sites in United Kingdom.
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 1 inclusion and 4 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: finished, as of the sponsor's last update on 18 May 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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 18 May 2010.