Pulmonary InfectionPREVIPNCT03687177
Visual Cue as Prevention of Pulmonary Infection Under Mechanical Ventilation
A study testing With visual cue and nurses informed and Without visual cue and nurses informed in people with Pulmonary Infection, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Nosocomial pneumonia is the third causes of nosocomial infection. In intensive care unit, their incidence is even higher, of the order of 10 to 30% in patients with invasive mechanical ventilation (IMV). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Infection
- What is being tested?
- With visual cue and nurses informed and Without visual cue and nurses informed
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteFrance
- Study dates
- 20 Sep 2018to 22 Oct 2019
- Phase
- Interventional
- 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
Who may be able to join
- Patient admitted to intensive care with invasive mechanical ventilation more than two days
Who cannot join
- Pregnancy
- Spinal trauma
- Brain trauma
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hôpitaux Universitaires de Strasbourg
Strasbourg, 67000
Sylvie L'Hotellier, 03.88.12.79.14, sylvie.l'hotellier@chru-strasbourg.fr
About this study
Nosocomial pneumonia is the third causes of nosocomial infection. In intensive care unit, their incidence is even higher, of the order of 10 to 30% in patients with invasive mechanical ventilation (IMV). One of the main mechanisms behind VAP (Ventilator-Associated Pneumonia) is the passage of germs colonizing the oropharynx to the subglottic airways. The presence of a nasogastric tube, immobilization, and strict dorsal decubitus increase the risk of colonization of the tracheobronchial tree and pneumonia in these patients. To reduce the incidence of VAP, several strategies have been developed in intensive care to try to control these different risk factors. These sets of measures, also called "bundle" systematically include the control of the elevation of the patient's head more than 30 °. Nevertheless, the strict and permanent control of the elevation of the patient's head is difficult to obtain. One of the reasons that may explain the difficulty of ensuring a correct elevation is the absence of visual cues that are easy to obtain on the beds of patients. An easily identifiable visual cue at the head of the bed would probably provide a satisfactory elevation (greater than 30 °) in patients intubated in intensive care. Our hypothesis is that the addition to the head of the patient's bed of a visible mark that is easily visible and easily interpretable by all the nurses will improve the elevation of the head of the patients in intensive care.
- Conditions
- Pulmonary Infection
- Being tested
- With visual cue and nurses informed, Without visual cue and nurses informed
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
With visual cue and nurses informedOther
Using visual cue or no visual cue with to estimate the angle of elevation of the head of intubated patients with prevention of nurse
Without visual cue and nurses informedOther
Not using visual cue or no visual cue with to estimate the angle of elevation of the head of intubated patients with prevention of nurse
| Study group | Role | What they receive |
|---|---|---|
| Control group | Other | Nurses from intensive care informed on the prevention of VAP and without visual cue to estimate the angle of elevation of the head of intubated patients Receives: Other: Without visual cue and nurses informed |
| Experimental group | Other | Nurses from intensive care informed on the prevention of VAP with visual cue to estimate the angle of elevation of the head of intubated patients. Receives: Other: With visual cue and nurses informed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of the angle of elevation of the head of patients with invasive mechanical ventilation
Measured: 3 times a day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2018
- Study start20 Sep 2018
- Primary completion22 Oct 2019 (estimated)
- Study completion22 Oct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary InfectionStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- 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
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03687177
- Sponsor's protocol ID
- 6793
- Acronym
- PREVIP
- Status last verified
- Sep 2018
- First submitted
- 25 Sep 2018
- Last updated
- 27 Sep 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Visual Cue as Prevention of Pulmonary Infection Under Mechanical Ventilation
- ClinicalTrials.gov ID
- NCT03687177
- Acronym / sponsor ID
- PREVIP / 6793
- Conditions
- Pulmonary Infection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 20 Sep 2018 (actual)
- Primary completion
- 22 Oct 2019 (estimated)
- Study completion
- 22 Oct 2019 (estimated)
- First posted
- 27 Sep 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.
Nosocomial pneumonia is the third causes of nosocomial infection. In intensive care unit, their incidence is even higher, of the order of 10 to 30% in patients with invasive mechanical ventilation (IMV). One of the main mechanisms behind VAP (Ventilator-Associated Pneumonia) is the passage of germs colonizing the oropharynx to the subglottic airways. The presence of a nasogastric tube, immobilization, and strict dorsal decubitus increase the risk of colonization of the tracheobronchial tree and pneumonia in these patients. To reduce the incidence of VAP, several strategies have been developed in intensive care to try to control these different risk factors. These sets of measures, also called "bundle" systematically include the control of the elevation of the patient's head more than 30 °. Nevertheless, the strict and permanent control of the elevation of the patient's head is difficult to obtain. One of the reasons that may explain the difficulty of ensuring a correct elevation is the absence of visual cues that are easy to obtain on the beds of patients. An easily identifiable visual cue at the head of the bed would probably provide a satisfactory elevation (greater than 30 °) in patients intubated in intensive care. Our hypothesis is that the addition to the head of the patient's bed of a visible mark that is easily visible and easily interpretable by all the nurses will improve the elevation of the head of the patients in intensive care.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Other | Other: Without visual cue and nurses informedNurses from intensive care informed on the prevention of VAP and without visual cue to estimate the angle of elevation of the head of intubated patients |
| Experimental group | Other | Other: With visual cue and nurses informedNurses from intensive care informed on the prevention of VAP with visual cue to estimate the angle of elevation of the head of intubated patients. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patient admitted to intensive care with invasive mechanical ventilation more than two days
Key exclusion criteria (3 listed)
- Pregnancy
- Spinal trauma
- Brain trauma
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 |
|---|---|---|
| With visual cue and nurses informedUsing visual cue or no visual cue with to estimate the angle of elevation of the head of intubated patients with prevention of nurse | Other | Experimental group |
| Without visual cue and nurses informedNot using visual cue or no visual cue with to estimate the angle of elevation of the head of intubated patients with prevention of nurse | Other | Control group |
Primary outcome
Measurement of the angle of elevation of the head of patients with invasive mechanical ventilation
Time frame: 3 times a day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2018.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing With visual cue and nurses informed and Without visual cue and nurses informed in people with Pulmonary Infection, run by University Hospital, Strasbourg, France 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 1 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 27 Sep 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sylvie L'HOTELLIER (03.88.12.79.14 ext. 033, sylvie.l'hotellier@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of the angle of elevation of the head of patients with invasive mechanical ventilation (time frame: 3 times a day). 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 27 Sep 2018; AzTrials last refreshed its copy on 7 Nov 2026.