First-in-man evaluation of a rapid, real-time, arterial oxygen sensor in the critically ill

First-in-man evaluation of a fibre optic sensor to monitor ventilatory oscillations in the arterial partial pressure of oxygen in real-time: a feasibility study in patients with the acute respiratory distress syndrome

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN10257246

Enrollment

Registered

2023-04-11

Start date

2023-06-01

Completion date

Unknown

Last updated

2023-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critically ill, mechanically ventilated patients with acute respiratory distress syndrome (ARDS) Respiratory

Interventions

Mechanically ventilated ARDS patients will be equipped with a real-time oxygen sensor inserted in an indwelling arterial catheter (already in place for clinical reasons) and connected to a monitoring

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Adult patient =18 years 2. Mechanically ventilated and sedated in controlled ventilation 3. PaO2 to inspired oxygen fraction (FiO2) ratio (P/F) =26.6 kPa 4. Indwelling arterial catheter 5. Planned for a PEEP change from 15 to 5 cmH2O to measure the recruitment to inflation ratio (R/I ratio)

Exclusion criteria

Exclusion criteria: 1. Pregnancy 2. Respiratory failure due to acute heart failure 3. Severe hemodynamic instability defined as either continuous infusion of noradrenaline (NA) at a rate >0.5 micrograms/kg/minute, or the presence of at least one cardiac support device: intra-aortic balloon pump (IABP), Impella, Veno-arterial extra-corporeal membrane oxygenation (VA-ECMO) 4. Tidal volume (Vt) 30 breaths/minute 6. Peripheral oxygen saturation (SpO2) <90%

Design outcomes

Primary

Measure	Time frame
The amplitude of PaO2 oscillations (peak to trough difference) is measured with the real-time oxygen sensor at the two levels of positive end expiratory pressure (PEEP 15 vs 5 cmH2O) required to calculate the recruitment to inflation (R/I) ratio	—

Secondary

Measure	Time frame
The phase of PaO2 oscillations (phase angle between PaO2 oscillations and airway pressure curve) is measured offline by superimposing the PaO2 and airway pressure signals (respectively from the oxygen sensor and the ventilator) obtained at the two levels of positive end expiratory pressure (PEEP 15 vs 5 cmH2O) required to calculate the recruitment to inflation (R/I) ratio. The amplitude and phase of PaO2 oscillations (measured as above) and other routinely monitored variables (see below) will be assessed during the following manoeuvres if and when the attending physician considers that they might be beneficial for the patient: 1. At the two levels of positive end expiratory pressure (PEEP 15 vs 5 cmH2O) required to assess the recruitment to inflation (R/I) ratio. 2. At the two levels of positive end expiratory pressure (PEEP 5 vs 45 cmH2O) required to measure static lung recruitability during lung computed tomography scan (CT scan). 3. Before and after a change in body position (e.g., from supine to prone, and/or from prone to supine) 4. Before and after any change in ventilatory or extracorporeal support settings 5. During any manoeuvre performed to assess lung mechanics (e.g., inspiratory/expiratory pause, static/dynamic pressure-volume loop) From the ventilator: airway pressures, flow, tidal volume (Vt), inspiratory to expiratory time ratio (I:E), respiratory system compliance, lung stress and strain, airway opening pressure; from the extracorporeal membrane oxygenator if present: extracorporeal sweep gas flow (SGF), blood flow, fraction of extracorporeal oxygen (FdO2)); from the analysis of CT scan if performed: functional residual capacity (FRC)), well-aerated/poorly aerated/non-aerated/hyperinflated lung volume; from the electrical impedence tomography (EIT) if present: lung impedance; from the ICU monitor: peripheral oxygen saturation (SpO2),	—

Measure

Time frame

The phase of PaO2 oscillations (phase angle between PaO2 oscillations and airway pressure curve) is measured offline by superimposing the PaO2 and airway pressure signals (respectively from the oxygen sensor and the ventilator) obtained at the two levels of positive end expiratory pressure (PEEP 15 vs 5 cmH2O) required to calculate the recruitment to inflation (R/I) ratio. The amplitude and phase of PaO2 oscillations (measured as above) and other routinely monitored variables (see below*) will be assessed during the following manoeuvres if and when the attending physician considers that they might be beneficial for the patient: 1. At the two levels of positive end expiratory pressure (PEEP 15 vs 5 cmH2O) required to assess the recruitment to inflation (R/I) ratio. 2. At the two levels of positive end expiratory pressure (PEEP 5 vs 45 cmH2O) required to measure static lung recruitability during lung computed tomography scan (CT scan). 3. Before and after a change in body position (e.g., from supine to prone, and/or from prone to supine) 4. Before and after any change in ventilatory or extracorporeal support settings 5. During any manoeuvre performed to assess lung mechanics (e.g., inspiratory/expiratory pause, static/dynamic pressure-volume loop) *From the ventilator: airway pressures, flow, tidal volume (Vt), inspiratory to expiratory time ratio (I:E), respiratory system compliance, lung stress and strain, airway opening pressure; from the extracorporeal membrane oxygenator if present: extracorporeal sweep gas flow (SGF), blood flow, fraction of extracorporeal oxygen (FdO2)); from the analysis of CT scan if performed: functional residual capacity (FRC)), well-aerated/poorly aerated/non-aerated/hyperinflated lung volume; from the electrical impedence tomography (EIT) if present: lung impedance; from the ICU monitor: peripheral oxygen saturation (SpO2),

—

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026