N/A
N=206
FiO2 Closed Loop Control Ventilation
Wounds and Injuries · Respiratory Failure
Bottom Line
View on ClinicalTrials.gov: NCT02810080 ↗Enrolled (actual)
206
Serious AEs
4.4%
Results posted
Aug 2024
Primary outcome: Primary: Relative Duration With Oxygen Saturation (SpO2) Within Target Range [Time Frame: 12 Hours] — 0.53; 0.61 arbitrary units
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Closed Loop Control Ventilation (Device); Manual Control Ventilation (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Zoll Medical Corporation
- Primary completion
- Dec 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Relative Duration With Oxygen Saturation (SpO2) Within Target Range [Time Frame: 12 Hours] |
0.53; 0.61 | — |
| PRIMARY Number of Participants With SpO2 Less Than 88% at Anytime While on Study Device |
31; 49 | — |
| SECONDARY 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] |
0.92; 0.83 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT02810080). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.