Status:
COMPLETED
FiO2 Closed Loop Control Ventilation
Lead Sponsor:
Zoll Medical Corporation
Collaborating Sponsors:
United States Air Force
Conditions:
Wounds and Injuries
Respiratory Failure
Eligibility:
All Genders
18-65 years
Brief Summary
A randomized, multi-center trial involving critically-ill patients comparing conventional, manual control of inspired oxygen (FiO2) within a target range, with a computer-controlled, closed-loop FiO2 ...
Detailed Description
The trial will use a proportional-integral-derivative (PID) type controller for automatic adjustment of FiO2 to maintain the SpO2 within a target range, based on continuous use of pulse oximetry. Intu...
Eligibility Criteria
Inclusion
- The subject's legally authorized representative will provide signed and dated informed consent.
- Age 18 - 65, inclusive.
- Admission to a surgical or neurosurgical intensive care unit following traumatic injury or acute surgical illness
- Requirement for endotracheal intubation
- Requirement for mechanical ventilation
- Patient is currently receiving inspired oxygen concentration (FiO2) \>=40%
Exclusion
- Age under 18 or over 65
- Isolated or severe head injury (Glasgow Coma Scale = 6 or less) with expected survival less than 24 hours
- Brain death
- Anticipated survival less than 48 hours
- Pregnant female
- Patient in whom a pulse oximeter cannot detect a reliable signal due to hypotension, hypothermia, or other injury
- Known carbon monoxide poisoning
- Uncontrolled diabetic
- Patient who is unable to maintain SpO2 level of 88% at an FiO2 of 100% due to their medical condition. (NOTE: Being in the trial would impose no additional risk to a patient who presents with this condition however, data from a patient presenting with this pathophysiology would not provide insight into the performance of the controller as it would simply maintain that patient on an FiO2 of 100%.)
- Patient with chronic hypercarbia.
- Patient where a physician believes that FiO2 PCLC could be detrimental to the management of the patient.
- Prisoner
- SpO2 to SaO2 difference \>4%
- Patient with core temperature \<35 C
Key Trial Info
Start Date :
December 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2020
Estimated Enrollment :
210 Patients enrolled
Trial Details
Trial ID
NCT02810080
Start Date
December 1 2016
End Date
December 1 2020
Last Update
August 15 2024
Active Locations (1)
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1
Regions Hospital
Saint Paul, Minnesota, United States, 55101