We hypothesize that the Respir8 is more accurate and reliable in measuring respiration rate than conventional methods like the stopwatch method (counting respiration rate by hand), capnography and the ECG-method. Furthermore we hypothise that…
ID
Bron
Verkorte titel
Aandoening
- respiration rate
- SpO2
- Respir8
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
1. Respiratory rate measured by the Respir8, the stopwatch method, capnography and ECG;<br>
2. Oxygen saturation.
Achtergrond van het onderzoek
The trial consist of three phases. Phase 1 and 2 are in healthy volunteers. Phase 3 is in patients.
Phase 1: Observe respiratory rate under normal breathing conditions and with a 50% increase and decrease in respiratory rate. RR will be measured with the new device the Respir8. Data collected from this device will be compared with the conventional methods capnography and stopwatch method.
Phase 2: Observe respiratory rate and SpO2 after an iv single bolus of remifentanil (50 ug/70 kg) under normal are conditions and with 50% oxygen. This allows assessment of the difference in speed of response between RR and SpO2 measurements.
Postoperative patients:
Phase 3: observe respiratory rate with the Respir8, capnography, stopwatch method and ECG-method and oxygen saturation in the recovery room in postoperative patients. This will allow comparison between the different methods regarding the best way to monitor the airway after surgery.
Doel van het onderzoek
We hypothesize that the Respir8 is more accurate and reliable in measuring respiration rate than conventional methods like the stopwatch method (counting respiration rate by hand), capnography and the ECG-method.
Furthermore we hypothise that insufficient breathing (and by this lowering of the oxygen saturation) will be noticed earlier by the respir8 compared to the conventional oxygen saturation measurement method (SpO2-probe).
Onderzoeksopzet
Phase 1. Respiratory rate will be measured for 1 minute every 5 minutes over a period of 20 minutes;
Phase 2. Respiratory rate and Spo2 will be monitored continuously for 20 minutes;
Phase 3. Respiratory rate and SpO2 will be measured will be collected every 10 minutes for the period the patient is in the recovery room.
Onderzoeksproduct en/of interventie
Healthy volunteers:
Phase 1: Observe respiratory rate under normal breathing conditions and with a 50% increase and decrease in respiratory rate;
Phase 2: Observe respiratory rate and SpO2 after an iv single bolus of remifentanil (50 ug/70 kg) under normal are conditions and with 50% oxygen.
Postoperative patients:
Phase 3: Observe respiratory rate (with three methods) and oxygen saturation on the recovery room in postoperative patients.
Publiek
Department of Anesthesiology,
P.O. Box 9600
Albert Dahan
Albinusdreef 2
Leiden 2300 RC
The Netherlands
+31 (0)71 5262301
a.dahan@lumc.nl
Wetenschappelijk
Department of Anesthesiology,
P.O. Box 9600
Albert Dahan
Albinusdreef 2
Leiden 2300 RC
The Netherlands
+31 (0)71 5262301
a.dahan@lumc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
Healthy volunteers and post-operative patients being able to give informed consent.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
For healthy volunteers:
1. Obesity (BMI > 35);
2. Presence of medical disease (heart-, lung-, liver-, kidney-, neurologic disease; diabetes m.; pyrosis; diaphragmatic hernia);
3. Presence of psychiatric disease;
4. History of chronic alcohol or illicit drug use;
5. Allergy to study medications;
6. Expected difficulty to hold to subject on mask causing leakage and inability to perform mask ventilation (i.e., Mallampati classification 3 or greater);
7. For females, we require the use of contraceptives.
For post-opartive patients: Presence of cardiopulmonary diseases.
Opzet
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL3015 |
| NTR-old | NTR3163 |
| Ander register | METC LUMC : P11-172 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |