FiO2 Closed Loop Control Ventilation (CLC)

FiO2 Closed Loop Control Using the ZOLL 731 Series Ventilator

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.

Study Overview

• Status: Completed
• Conditions: Wounds and Injuries; Respiratory Failure
• Intervention / Treatment: Device: Closed Loop Control Ventilation; Device: Manual Control Ventilation

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.

• Study Type: Interventional
• Enrollment (Actual): 210

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Saint Paul, Minnesota, United States, 55101
      • Regions Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Closed Loop Control Ventilation; automatic adjustment of the ZOLL 731 ventilator FiO2 by the closed loop control software	Device: Closed Loop Control Ventilation; Closed loop control ventilation using ZOLL 731 ventilator with physiologic closed-loop control software
Active Comparator: Manual Control Ventilation; manual adjustment of the ZOLL 731 ventilator FiO2 by the treatment team based on physician order	Device: Manual Control Ventilation; Manual control ventilation using ZOLL 731 ventilator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relative Duration With Oxygen Saturation (SpO2) Within Target Range [Time Frame: 12 Hours]	Relative duration is (time within SpO2 target of 92-96%)/12 hours where higher value demonstrates better ability of FiO2 control method to maintain appropriate oxygen saturation. Relative time the patient's SpO2 was maintained within target over the 12 hours on the study device, calculated as total time each patient had SpO2 within the 92 - 96% range divided by 12 hours with arcsin square root transformation	12 hours
Number of Participants With SpO2 Less Than 88% at Anytime While on Study Device	Number of participants with SpO2 less than 88% at anytime while on study device	24 hours after intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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]	Relative duration is (time within SpO2 target of either a) 92-96% when FiO2 is greater than 21% or b) greater than or equal to 92% when FiO2 equals 21%)/12 hours where higher value demonstrates better ability of FiO2 control method to maintain appropriate oxygen saturation. Relative time the patient's SpO2 was maintained within target over the 12 hours on the study device, calculated as total time each patient had SpO2 within the range divided by 12 hours with arcsin square root transformation	12 hours

Collaborators and Investigators

• Sponsor: Zoll Medical Corporation
• Collaborators: United States Air Force

Study record dates

Study Major Dates

• Study Start: December 1, 2016
• Primary Completion (Actual): December 1, 2020
• Study Completion (Actual): December 1, 2020

Study Registration Dates

• First Submitted: June 20, 2016
• First Submitted That Met QC Criteria: June 20, 2016
• First Posted (Estimated): June 22, 2016

Study Record Updates

• Last Update Posted (Actual): August 15, 2024
• Last Update Submitted That Met QC Criteria: August 8, 2024
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency; Wounds and Injuries
• Other Study ID Numbers: 9703

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO