This is a pilot study aimed at acquiring primary physiological data, describing and estimating the effects of a 5-HT3 receptor antagonist (ondansetron) on respiratory drive in patients with acute respiratory distress syndrome (ARDS). The results of this study will determine the interest and feasibility of assessing the clinical applications of ondansetron in reducing patient self-inflicted lung injury (P-SILI) in ARDS, in subsequent studies.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Single intravenous dose of 10 mL of sodium chloride (NaCl) 0.9% over 15 minutes.
Single intravenous dose of ondansetron hydrochloride dihydrate 0.15 mg/kg (maximum 16 mg) in 10 mL of NaCl 0.9% over 15 minutes.
Hôpital Sacré-Coeur de Montréal
Montreal, Quebec, Canada
RECRUITINGPressure-time product of the esophageal pressure per minute
Difference in mean pressure-time product of the esophageal pressure per minute between placebo phase and ondansetron phase
Time frame: Continuous measurement during each 2-hour phase
Respiratory rate
Difference in mean respiratory rate between placebo phase and ondansetron phase
Time frame: Continuous measurement during each 2-hour phase
Tidal volume
Difference in mean tidal volume between placebo phase and ondansetron phase
Time frame: Continuous measurement during each 2-hour phase
Pressure-time product of the esophageal pressure per breath
Difference in mean pressure-time product of the esophageal pressure per breath between placebo phase and ondansetron phase
Time frame: Continuous measurement during each 2-hour phase
Esophageal pressure swings
Difference in mean esophageal pressure swings between placebo phase and ondansetron phase
Time frame: Continuous measurement during each 2-hour phase
Transpulmonary pressure swings
Difference in mean transpulmonary pressure swings between placebo phase and ondansetron phase
Time frame: Continuous measurement during each 2-hour phase
Estimated occlusion pressure at 0.1 msec (P0.1)
Difference in mean estimated occlusion pressure at 0.1 msec (P0.1) between placebo phase and ondansetron phase
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Time frame: Continuous measurement during each 2-hour phase
Peak electrical activity of the diaphragm (Eadi)
Difference in mean peak Eadi between placebo phase and ondansetron phase
Time frame: Continuous measurement during each 2-hour phase
Area under the Eadi curve
Difference in area under the Eadi curve between placebo phase and ondansetron phase
Time frame: Continuous measurement during each 2-hour phase
End-tidal CO2 (EtCO2)
Difference in mean EtCO2 between placebo phase and ondansetron phase
Time frame: Continuous measurement during each 2-hour phase
Volume of expired CO2 (VCO2)
Difference in mean VCO2 between placebo phase and ondansetron phase
Time frame: Continuous measurement during each 2-hour phase
Oxygen saturation estimated by pulse oximetry (SpO2)
Difference in mean SpO2 between placebo phase and ondansetron phase
Time frame: Measurement every 5 minutes during each 2-hour phase
Partial pressure of carbon dioxide in arterial blood (PaCO2)
Difference in mean PaCO2 between placebo phase and ondansetron phase
Time frame: Measurement every 30 minutes during each 2-hour phase
Partial pressure of oxygen in arterial blood (PaO2)
Difference in mean PaO2 between placebo phase and ondansetron phase
Time frame: Measurement every 30 minutes during each 2-hour phase
Heart rate
Difference in mean heart rate between placebo phase and ondansetron phase
Time frame: Measurement every 5 minutes during each 2-hour phase
Mean arterial pressure (MAP)
Difference in mean MAP between placebo phase and ondansetron phase
Time frame: Measurement every 5 minutes during each 2-hour phase
Corrected QT length (QTc)
Difference in QTc between placebo phase and ondansetron phase
Time frame: Measurement once (at the 1 hour-mark) during each 2-hour phase
Temperature
Difference in mean temperature between placebo phase and ondansetron phase
Time frame: Hourly measurement during each 2-hour phase
Richmond Agitation and Sedation Scale (RASS)
Difference in mean Richmond Agitation and Sedation Scale (RASS) between placebo phase and ondansetron phase. This scale goes from -5 (unraousable) to +4 (combative).
Time frame: Hourly measurement during each 2-hour phase
Critical care Pain Observation Tool (CPOT)
Difference in mean Critical care Pain Observation Tool (CPOT) between placebo phase and ondansetron phase. This scale goes from 0 (lowest pain level) to 10 (highest pain level).
Time frame: Hourly measurement during each 2-hour phase