Altered Mental StatusNCT05604430
Pre-hospital Ventilation Clinical Study
An observational study of Altered Mental Status and Sepsis, run by Zoll Medical Corporation at 5 sites in United States.
Trial summary
This study will collect and characterize ventilator use during patient care with a ZOLL 731 Series ventilator in a pre-hospital setting. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Altered Mental Status, Sepsis, Heart Failure
- What is being tested?
- 731 Series Ventilator
- Type of treatment
- Medical device
- How many people
- 500 participants
- Where
- 5 sitesUnited States
- Study dates
- 30 Jun 2022to 30 Apr 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Cases where participating EMS Agencies use ZOLL 731 Series ventilator in accordance with device labeling and Agency protocols in a pre-hospital setting
Who may be able to join
- Candidates for this study must meet all of the following Inclusion criteria:
- Ventilated using ZOLL 731 Series ventilator with Release 5 (or greater) software
- Data recorded in ventilator data file
Who cannot join
- None
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites
East Baton Rouge EMS
Baton Rouge, Louisiana, 70807
MedStar
Fort Worth, Texas, 76116
Aetna Ambulance Service, Inc
Hartford, Connecticut, 06106
Gig Harbor Fire Department
Rosedale, Washington, 98332
Uxbridge Fire
Uxbridge, Massachusetts, 01569
About this study
This study will collect and characterize ventilator use during patient care with a ZOLL 731 Series ventilator in a pre-hospital setting.
Read the detailed description
This is a prospective, observational study.
ZOLL will develop a methodology to collect and transfer ventilator data from the device to ZOLL to allow for a characterization of ventilator use in the pre-hospital setting. This knowledge and experience will subsequently be used to inform development of a mechanism to allow for automatic data collection and transmission from ZOLL ventilators to a central data repository. These data will be used to provide feedback, reporting, and benchmarking to individual agencies and departments on their ventilator use as well as aggregate use data from all ventilators to allow for comparisons.
Enrollment in this study is expected to take approximately 24 months. No patient outcome data will be collected.Participants are enrolled once data have been downloaded from the ventilator via RescueNet® VentReview software. Participants will not be followed after the assessment of study objectives.
- Conditions
- Altered Mental Status, Sepsis, Heart Failure, Hemorrhage, Respiratory Distress Syndrome, Adult, Cardiac Arrest
- Being tested
- 731 Series Ventilator
- Keywords
- Ventilation, Pre-Hospital
- Medical subject headings
- Sepsis, Heart Failure, Hemorrhage, Respiratory Distress Syndrome, Heart Arrest, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
731 Series VentilatorDevice
FDA cleared ventilator indicated for use in the management of acute or chronic respiratory failure or during resuscitation.
| Study group | Role | What they receive |
|---|---|---|
| Ventilator patients | Patients being ventilated by the ZOLL 731 Series ventilator in accordance with device labeling and Agency protocols in a pre-hospital setting. Receives: Device: 731 Series Ventilator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ventilator modes used
Characterizing how often ventilator modes are used during mechanical ventilation
Measured: Through study completion, an average 1 hour
Ventilator settings used
Characterizing how often ventilator settings are changed during mechanical ventilation
Measured: Through study completion, an average 1 hour
Ventilator Alarm type
Characterize type of alarms triggered during mechanical ventilation
Measured: Through study completion, an average 1 hour
Ventilator Alarm Frequency
Characterize frequency of alarms triggered during mechanical ventilation
Measured: Through study completion, an average 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2022
- Study start30 Jun 2022
- Primary completion30 Apr 2030 (estimated)
- Study completion30 Apr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Altered Mental StatusStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zoll Medical Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05604430
- Sponsor's protocol ID
- 76701
- Status last verified
- Aug 2026
- First submitted
- 11 Jul 2022
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-hospital Ventilation Clinical Study
- ClinicalTrials.gov ID
- NCT05604430
- Acronym / sponsor ID
- 76701
- Conditions
- Altered Mental Status, Sepsis, Heart Failure, Hemorrhage, Respiratory Distress Syndrome, Adult, Cardiac Arrest
- Keywords
- Ventilation, Pre-Hospital
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Zoll Medical CorporationIndustry (pharma, biotech, devices)
- Study start
- 30 Jun 2022 (actual)
- Primary completion
- 30 Apr 2030 (estimated)
- Study completion
- 30 Apr 2030 (estimated)
- First posted
- 3 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will collect and characterize ventilator use during patient care with a ZOLL 731 Series ventilator in a pre-hospital setting.
Detailed description
This is a prospective, observational study.
ZOLL will develop a methodology to collect and transfer ventilator data from the device to ZOLL to allow for a characterization of ventilator use in the pre-hospital setting. This knowledge and experience will subsequently be used to inform development of a mechanism to allow for automatic data collection and transmission from ZOLL ventilators to a central data repository. These data will be used to provide feedback, reporting, and benchmarking to individual agencies and departments on their ventilator use as well as aggregate use data from all ventilators to allow for comparisons.
Enrollment in this study is expected to take approximately 24 months. No patient outcome data will be collected.Participants are enrolled once data have been downloaded from the ventilator via RescueNet® VentReview software. Participants will not be followed after the assessment of study objectives.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ventilator patients | – | Device: 731 Series VentilatorPatients being ventilated by the ZOLL 731 Series ventilator in accordance with device labeling and Agency protocols in a pre-hospital setting. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Cases where participating EMS Agencies use ZOLL 731 Series ventilator in accordance with device labeling and Agency protocols in a pre-hospital setting
Key inclusion criteria (3 listed)
- Candidates for this study must meet all of the following Inclusion criteria:
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| 731 Series VentilatorFDA cleared ventilator indicated for use in the management of acute or chronic respiratory failure or during resuscitation. | Device | Ventilator patients |
Primary outcome
Ventilator modes used
Time frame: Through study completion, an average 1 hour
Characterizing how often ventilator modes are used during mechanical ventilation
Ventilator settings used
Time frame: Through study completion, an average 1 hour
Characterizing how often ventilator settings are changed during mechanical ventilation
Ventilator Alarm type
Time frame: Through study completion, an average 1 hour
Characterize type of alarms triggered during mechanical ventilation
Ventilator Alarm Frequency
Time frame: Through study completion, an average 1 hour
Characterize frequency of alarms triggered during mechanical ventilation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Altered Mental Status and Sepsis, run by Zoll Medical Corporation at 5 sites 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 3 inclusion and 1 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: enrolling by invitation, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
This study is still under way. Results are not available in the source record yet.
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?
Ventilator modes used (time frame: Through study completion, an average 1 hour). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Sep 2026.