Clinical trial NCT02810080: FiO2 Closed Loop Control Ventilation
Official title: FiO2 Closed Loop Control Using the ZOLL 731 Series Ventilator
Study type: INTERVENTIONAL
Overall status: COMPLETED
Conditions: Wounds and Injuries
Respiratory Failure
Lead sponsor: Zoll Medical Corporation
Sponsor class: INDUSTRY
Collaborators: name: United States Air Force
First posted: 2016-06-22
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 delivery using a continuous ventilator.

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. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Relative Duration With Oxygen Saturation (SpO2) Within Target Range [Time Frame: 12 Hours]
timeFrame: 12 hours
measure: Number of Participants With SpO2 Less Than 88% at Anytime While on Study Device
timeFrame: 24 hours after intervention
Secondary outcomes:
measure: Relative Duration of Time With SpO2 92 to 96% When FiO2 is Greater Than 21% and SpO2 is Greater Than or Equal to 92% When Fi02 "Relative Duration With Oxygen Saturation (SpO2) Within Target Range [Time Frame: 12 Hours]
timeFrame: 12 hours
Other outcomes:
Locations:
city: Saint Paul
country: United States
facility: Regions Hospital
state: Minnesota
Study officials:
References: