|- candidate number||10581|
|- NTR Number||NTR3163|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||26-nov-2011|
|- Secondary IDs||P11-172 METC LUMC|
|- Public Title||A comparison between different methods to measure respiration rate.|
|- Scientific Title||Respiratory rate measurements: A comparison of methods in healthy volunteers and postoperative patients - a pilot study.|
|- ACRONYM||The Respir8 Study|
|- hypothesis||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).
|- Healt Condition(s) or Problem(s) studied||Respiration rate, SpO2|
|- Inclusion criteria||Healthy volunteers and post-operative patients being able to give informed consent.|
|- Exclusion criteria||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.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, non-randomized|
|- planned startdate ||1-dec-2011|
|- planned closingdate||1-dec-2012|
|- Target number of participants||50|
|- Interventions||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.
Phase 3: Observe respiratory rate (with three methods) and oxygen saturation on the recovery room in postoperative patients.
|- Primary outcome||1. Respiratory rate measured by the Respir8, the stopwatch method, capnography and ECG;|
2. Oxygen saturation.
|- Secondary outcome||No secondary outcomes will be measured in this study.|
|- Timepoints||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.
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Prof. Dr. Albert Dahan|
|- CONTACT for SCIENTIFIC QUERIES||Prof. Dr. Albert Dahan|
|- Sponsor/Initiator ||Leiden University Medical Center (LUMC)|
(Source(s) of Monetary or Material Support)
|Leiden University Medical Center (LUMC)|
|- Brief summary||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.
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.
|- Main changes (audit trail)|
|- RECORD||26-nov-2011 - 12-dec-2011|