FiO2 Closed Loop Control Ventilation

NCT02810080 | Completed Results DMC

• 1 other identifier: 9703
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

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.

Conditions

Wounds and Injuries; Respiratory Failure

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• 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]

  12 hours

Study Arms (2)

Closed Loop Control Ventilation

EXPERIMENTAL

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

Device: Closed Loop Control Ventilation

Manual Control Ventilation

ACTIVE COMPARATOR

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

Device: Manual Control Ventilation

Interventions

Closed Loop Control Ventilation DEVICE

Closed loop control ventilation using ZOLL 731 ventilator with physiologic closed-loop control software

Closed Loop Control Ventilation

Manual Control Ventilation DEVICE

Manual control ventilation using ZOLL 731 ventilator

Manual Control Ventilation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• 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

Sponsors & Collaborators

• Zoll Medical Corporation: lead
• United States Air Force: collaborator

Study Sites (1)

Regions Hospital

Saint Paul, Minnesota, 55101, United States

Location

MeSH Terms

Conditions

Wounds and Injuries; Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Results Point of Contact

• Title: Nathan Burkhart
• Organization: ZOLL

nburkhart@zoll.com

763.367.0462

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2016
• First Posted: June 22, 2016
• Study Start: December 1, 2016
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: August 15, 2024
• Results First Posted: August 15, 2024

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)