Mechanical VentilationSOH-VAPNCT03434821
Hyperoxemia and Ventilator-associated Pneumonia
An observational study of Mechanical Ventilation, run by University Hospital, Lille at 1 site in France.
Trial summary
The aim of this prospective cohort single-center observational study is to determine the impact of hyperoxemia on ventilator-associated pneumonia (VAP) occurrence. SpO2 will be continuously recorded in order to determine the percentage of time spent with hyperoxemia. Patients with VAP will be prospectively identified. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mechanical Ventilation
- How many people
- 534 participants
- Where
- 1 siteFrance
- Study dates
- 15 Mar 2018to 30 Apr 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients hospitalized in intensive care unit requiring invasive mechanical ventilation (IV) for more than 48 hours.
Who may be able to join
- Adult patients admitted to the ICU
- Expected duration of mechanical ventilation > 48h
- Signed informed consent
- Social insurance
Who cannot join
- Pregnancy or breast feeding
- No informed consent
- Hyperbaric oxygen treatment
- Prisoners and patients under guardianship
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Hyperoxemia on Incidence of Ventilator-associated Pneumonia
The aim of this prospective cohort single-center observational study is to determine the impact of hyperoxemia on ventilator-associated pneumonia (VAP) occurrence.
- SpO2 will be continuously recorded in order to determine the percentage of time spent with hyperoxemia.
- Patients with VAP will be prospectively identified.
- Patient characteristics and risk factors for VAP will be prospectively collected.
- Oxidant stress will be prospectively investigated in study patients: glutathion peroxidase (GPX), plasmatic superoxyde dismutase (SOD), total plasmatic antioxidant status (SAT) and urinary 8-isoprostanes will be performed at ICU admission, once a week, and at VAP occurrence.
Patients with VAP will be compared with those with no VAP
- Conditions
- Mechanical Ventilation
- Keywords
- Hyperoxemia, ventilator-associated, pneumonia, critical illness
- Medical subject headings
- Pneumonia, Critical Illness
What is being measured
The primary outcome is the main question the study is designed to answer.
VAP occurrence
hyperoxemia at ICU admission (PaO2 >120 mmHg)
Measured: 28 days after ICU admission
Secondary outcomes (3)
percentage of time spent with hyperoxemia during ICU stay
hyperoxemia is defined as peripheral O2 saturation (SaO2)>98%, SaO2 will be measured every 30 seconds, and the percentage of time spent with hyperoxemia will be calculated per day.
Measured: 28 days after ICU admission
relationship between hyperoxemia at ICU admission and the presence of acute lung injury (ALI)
the presence of hyperoxemia at ICU admission will be determined using blood gazes (arterial PaO2>120 mmHg). The percentage of patients with hyperoxemia will be compared between patients with Ali, and those with no ALI
Measured: 28 days after ICU admission
percentage of time spent with hyperoxemia during ICU stay, and the presence of acute lung injury
the percentage of time spent with hyperoxemia during ICU stay will be calculated as mentioned above (outcome 2). This percentage will be compared between patient with ALI and those with no ALI
Measured: 28 days after ICU admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2018
- Study start15 Mar 2018
- Primary completion30 Apr 2022
- Study completion30 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanical VentilationStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 534 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Saad Nseir, MD,PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03434821
- Sponsor's protocol ID
- 2016_73
- Other IDs
- 2017-A01934-49
- Acronym
- SOH-VAP
- Status last verified
- Jun 2022
- First submitted
- 6 Feb 2018
- Last updated
- 6 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Hyperoxemia on Incidence of Ventilator-associated Pneumonia
- ClinicalTrials.gov ID
- NCT03434821
- Acronym / sponsor ID
- SOH-VAP / 2016_73
- Conditions
- Mechanical Ventilation
- Keywords
- Hyperoxemia, ventilator-associated, pneumonia, critical illness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 534 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 15 Mar 2018 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 15 Feb 2018 (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.
The aim of this prospective cohort single-center observational study is to determine the impact of hyperoxemia on ventilator-associated pneumonia (VAP) occurrence.
- SpO2 will be continuously recorded in order to determine the percentage of time spent with hyperoxemia.
- Patients with VAP will be prospectively identified.
- Patient characteristics and risk factors for VAP will be prospectively collected.
- Oxidant stress will be prospectively investigated in study patients: glutathion peroxidase (GPX), plasmatic superoxyde dismutase (SOD), total plasmatic antioxidant status (SAT) and urinary 8-isoprostanes will be performed at ICU admission, once a week, and at VAP occurrence.
Patients with VAP will be compared with those with no VAP
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients hospitalized in intensive care unit requiring invasive mechanical ventilation (IV) for more than 48 hours.
Key inclusion criteria (4 listed)
- Adult patients admitted to the ICU
- Expected duration of mechanical ventilation > 48h
- Signed informed consent
- Social insurance
Key exclusion criteria (4 listed)
- Pregnancy or breast feeding
- No informed consent
- Hyperbaric oxygen treatment
- Prisoners and patients under guardianship
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
VAP occurrence
Time frame: 28 days after ICU admission
hyperoxemia at ICU admission (PaO2 >120 mmHg)
3 secondary outcomes
percentage of time spent with hyperoxemia during ICU stay
Time frame: 28 days after ICU admission
relationship between hyperoxemia at ICU admission and the presence of acute lung injury (ALI)
Time frame: 28 days after ICU admission
percentage of time spent with hyperoxemia during ICU stay, and the presence of acute lung injury
Time frame: 28 days after ICU admission
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2022.
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Development and Prospective Validation of the AutoEIT Foundation Model for ARDS
ARDS (Acute Respiratory Distress Syndrome), Respiratory Failure
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Predicting the Need for Invasive Mechanical Ventilation Using Different Risk Scores
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Early Identification of Pathogens in Children With Respiratory Tract Infection by Mechanical Ventilation Using mNGS
VAP - Ventilator Associated Pneumonia
Not yet recruitingObservational study
Detecting Early Weaning-induced Pulmonary Oedema Using Lung Impedance Negative Trend During Spontaneous Breathing Trials
Weaning-induced Pulmonary Edema, Mechanical Ventilation Weaning
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.
Saad Nseir, MD,PhD principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mechanical Ventilation, run by University Hospital, Lille at 1 site in France.
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 4 inclusion and 4 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 6 Jul 2022. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
VAP occurrence (time frame: 28 days after ICU admission). 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 6 Jul 2022.