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…
ID
Bron
Verkorte titel
Aandoening
N/A
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Respiratory rate
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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.
Onderzoeksopzet
6 hours
Onderzoeksproduct en/of interventie
Measuring breathing frequency due Respir8 mask during 6 hours postoperative
Publiek
Albinusdreef 2
M. Velzen, van
Leiden 2333 ZA
The Netherlands
+31 (0)71 5262301
m.van_velzen@lumc.nl
Wetenschappelijk
Albinusdreef 2
M. Velzen, van
Leiden 2333 ZA
The Netherlands
+31 (0)71 5262301
m.van_velzen@lumc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
• 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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
• Head, neck and facial surgery
• Inability to wear or retain a standard oxygen mask post-operatively
• Emergency (non-elective) surgery
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL4075 |
| NTR-old | NTR4778 |
| Ander register | P14.159 : RespiR8 |