Cardiospire study

JRCT ID: jRCTs062210080

Registered date:28/02/2022

Basic Information

• Recruitment status: Suspended
• Health condition(s) or Problem(s) studied: Cases requiring pulmonary artery catheter for usual clinical care
• Date of first enrollment: 23/06/2023
• Target sample size: 100
• Study type: Interventional

Intervention(s)

For patients on mechanical ventilation, a Cardiospire is connected to the ventilator circuit to measure cardiogenic oscillation signal to calculate cardiac output and pulmonary arterial pressure.
Aftert evaluating the eligibility, each subject will have at least two instances of fluid bolus (300-500ml) or passive leg raise maneuver (legs raised to a 30 degree angle and held in this position for 2 minutes).

Outcome(s)

• Primary Outcome: Cardiac output and pulmonary arterial pressure.
• Secondary Outcome: Not applicable

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. Patient must 18 or more years of age
2. Patient must be intubated
3. Patient must have a pulmonary artery catheter placed as part of usual clinical care
4. Patient or patient's legally authorized representative is able to provide informed consent

Exclude criteria

1.Subjects who, at the principal investigator's determination, would not be appropriate for this study.
2.Patient is not able to provide informed consent due to cognitive impairment.

Related Information

• Primary Sponsor: Morimatsu Hiroshi
• Secondary Sponsor: Respirix, Inc.