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An observational study measuring respiratory rate as assessed by RespiR8 in post operative patients aged 60 years and above


- candidate number19422
- NTR NumberNTR4778
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR9-sep-2014
- Secondary IDsRespiR8 P14.159
- Public TitleAn observational study measuring respiratory rate as assessed by RespiR8 in post operative patients aged 60 years and above
- Scientific TitleAn observational study measuring respiratory rate as assessed by RespiR8 in post operative patients aged 60 years and above
- ACRONYMRespiR8
- hypothesisThe primary objective is to estimate the frequency of subjects with at least one apnoeic episode, defined as respiratory rate ≤6, detected using the respiR8 device for up to 6 hours after surgery. Apnoea is defined as 10 seconds of no breathing activity or a respiratory rate ≤6 of undefined duration.
- Healt Condition(s) or Problem(s) studiedApnea, Respiration, Post operative
- Inclusion criteria Males and females having elective surgery
Having surgery requiring anaesthesia for at least 60 minutes
Aged ≥ 60 years
Expected to stay in hospital for at least 12 hours
General Anaesthesia / regional anaesthesia
Able to read and understand the English or Dutch Patient Information Leaflet and Consent Form.
- Exclusion criteria Head, neck and facial surgery
Inability to wear or retain a standard oxygen mask post-operatively
Emergency (non-elective) surgery
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeobservational
- planned startdate 14-mrt-2014
- planned closingdate1-dec-2014
- Target number of participants50
- InterventionsMeasuring breathing frequency due Respir8 mask during 6 hours postoperative
- Primary outcomeRespiratory rate
- Secondary outcomeOxygen saturation
- Timepoints6 hours
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES M. Velzen, van
- CONTACT for SCIENTIFIC QUERIES M. Velzen, van
- Sponsor/Initiator Anaxsys Technology Ltd
- Funding
(Source(s) of Monetary or Material Support)
Anaxsys Technology Ltd
- Publications
- Brief summaryAfter oral and written information is provided, informed consent is signed to collect demographic and medical information, measure respiratoir rate and saturation. Subject will wear the respiR8 mask 6 hours postoperative for continue measurement of respiratory rate and oxygen saturation. Respiratory rate ≤10, >18 and SpO2 level < 94% will be reported. Action and intervention taken by clinical staff will also be reported. Study is completed after 6 hours.
- Main changes (audit trail)
- RECORD9-sep-2014 - 1-okt-2014


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