No registrations found.
ID
Source
Brief title
Health condition
N/A
Sponsors and support
Intervention
Outcome measures
Primary outcome
Respiratory rate
Secondary outcome
Oxygen saturation
Background summary
After 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.
Study objective
The 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.
Study design
6 hours
Intervention
Measuring breathing frequency due Respir8 mask during 6 hours postoperative
Albinusdreef 2
M. Velzen, van
Leiden 2333 ZA
The Netherlands
+31 (0)71 5262301
m.van_velzen@lumc.nl
Albinusdreef 2
M. Velzen, van
Leiden 2333 ZA
The Netherlands
+31 (0)71 5262301
m.van_velzen@lumc.nl
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL4075 |
| NTR-old | NTR4778 |
| Other | P14.159 : RespiR8 |