FiO2 Closed Loop Control Ventilation (CLC)

ZOLL Medical

Status: Completed

Conditions: Respiratory Failure; Wounds and Injuries

Treatments: Device: Closed Loop Control Ventilation; Device: Manual Control Ventilation

Study type: Interventional

Funder types: Industry; Other U.S. Federal agency

Identifiers

NCT02810080

9703

Details and patient eligibility

About

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 delivery using a continuous ventilator.

Full 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. Intubated subjects will be randomized to either manual control of FiO2 or closed-loop control of FiO2, during a 12-hour period. The PCLC is designed to respond to acute hypoxemia (SpO2 <88%) within seconds while preventing hypoxemia and minimizing exposure to excessive inspired oxygen levels.

Enrollment: 210 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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210 participants in 2 patient groups

Closed Loop Control Ventilation

Experimental group

Description:

automatic adjustment of the ZOLL 731 ventilator FiO2 by the closed loop control software

Treatment:

Device: Closed Loop Control Ventilation

Manual Control Ventilation

Active Comparator group

Description:

manual adjustment of the ZOLL 731 ventilator FiO2 by the treatment team based on physician order

Treatment:

Device: Manual Control Ventilation