Wounds and InjuriesCLCNCT02810080

FiO2 Closed Loop Control Ventilation

A study of Wounds and Injuries and Respiratory Failure, run by Zoll Medical Corporation at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Wounds and Injuries, Respiratory Failure
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 210 participants
Where: 1 siteUnited States
Study dates: Dec 2016to Dec 2020
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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%

Who cannot join

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

Show all 14Show fewer

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 locations and contacts

1 site in 1 country.

United States1 site

Regions Hospital
Saint Paul, Minnesota, 55101

Other trials in United States

About this study

Official title: FiO2 Closed Loop Control Using the ZOLL 731 Series Ventilator

Read the 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.

Conditions: Wounds and Injuries, Respiratory Failure
Being tested: Closed Loop Control Ventilation, Manual Control Ventilation
Medical subject headings: Wounds and Injuries, Respiratory Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Closed Loop Control VentilationDevice
Closed loop control ventilation using ZOLL 731 ventilator with physiologic closed-loop control software
Manual Control VentilationDevice
Manual control ventilation using ZOLL 731 ventilator

Study groups in NCT02810080
Study group	Role	What they receive
Closed Loop Control Ventilation	Experimental	automatic adjustment of the ZOLL 731 ventilator FiO2 by the closed loop control software Receives: 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 Receives: Device: Manual Control Ventilation

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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
Measured: 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]
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
Measured: 12 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2016Dec 2020

First posted22 Jun 2016 (estimated)
Study startDec 2016
Primary completionDec 2020
Study completionDec 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Wounds and InjuriesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 210 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02810080
Sponsor's protocol ID: 9703
Acronym: CLC
Status last verified: Apr 2023
First submitted: 20 Jun 2016
Last updated: 15 Aug 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 15 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: FiO2 Closed Loop Control Using the ZOLL 731 Series Ventilator
ClinicalTrials.gov ID: NCT02810080
Acronym / sponsor ID: CLC / 9703
Conditions: Wounds and Injuries, Respiratory Failure
Study type: Interventional
Recruitment status: Completed
Enrolment: 210 participants (actual)
Lead sponsor: Zoll Medical CorporationIndustry (pharma, biotech, devices)
Collaborators: United States Air Force
Study start: Dec 2016
Primary completion: Dec 2020 (actual)
Study completion: Dec 2020 (actual)
First posted: 22 Jun 2016 (estimated)
Results: Posted 15 Aug 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Closed Loop Control Ventilation	Experimental	Device: Closed Loop Control Ventilationautomatic adjustment of the ZOLL 731 ventilator FiO2 by the closed loop control software
Manual Control Ventilation	Active comparator	Device: Manual Control Ventilationmanual adjustment of the ZOLL 731 ventilator FiO2 by the treatment team based on physician order

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (14 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Closed Loop Control VentilationClosed loop control ventilation using ZOLL 731 ventilator with physiologic closed-loop control software	Device	Closed Loop Control Ventilation
Manual Control VentilationManual control ventilation using ZOLL 731 ventilator	Device	Manual Control Ventilation

Primary outcome

Relative Duration With Oxygen Saturation (SpO2) Within Target Range [Time Frame: 12 Hours]
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
Number of Participants With SpO2 Less Than 88% at Anytime While on Study Device
Time frame: 24 hours after intervention
Number of participants with SpO2 less than 88% at anytime while on study device

1 secondary outcome

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]
Time frame: 12 hours

Results and safety

Results posted to the registry on 15 Aug 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Closed Loop Control Ventilation	104	97
Manual Control Ventilation	102	98

Primary outcome: Relative Duration With Oxygen Saturation (SpO2) Within Target Range [Time Frame: 12 Hours]

Time frame: 12 hours. Mean (Standard Deviation). Unit: arbitrary units

Measure	Closed Loop Control Ventilation n = 104	Manual Control Ventilation n = 102
Value	0.53 (0.37)	0.61 (0.36)

Primary outcome: Number of Participants With SpO2 Less Than 88% at Anytime While on Study Device

Time frame: 24 hours after intervention. Count of participants. Unit: Participants

Measure	Closed Loop Control Ventilation n = 104	Manual Control Ventilation n = 102
Value	31	49

1 secondary outcome is reported in the full results.

Adverse events

Time frame: From enrollment until 24 hours after study device discontinuation, a period of 36 to 48 hours after study device placement.. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Closed Loop Control Ventilation	0 of 104 (0%)	24 of 104 (23.1%)	0 of 104
Manual Control Ventilation	9 of 102 (8.8%)	17 of 102 (16.7%)	2 of 102

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study of Wounds and Injuries and Respiratory Failure, run by Zoll Medical Corporation at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Relative Duration With Oxygen Saturation (SpO2) Within Target Range [Time Frame: 12 Hours] (time frame: 12 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02810080.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2024.