Back to resultsVisual Cue as Prevention of Pulmonary Infection Under Mechanical Ventilation (PREVIP)
Primary Purpose
Pulmonary Infection
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
With visual cue and nurses informed
Without visual cue and nurses informed
Sponsored by
About this trial
This is an interventional prevention trial for Pulmonary Infection
Eligibility Criteria
Inclusion Criteria:
- Patient admitted to intensive care with invasive mechanical ventilation more than two days
Exclusion Criteria:
- Pregnancy
- Spinal trauma
- Brain trauma
Sites / Locations
- Hôpitaux Universitaires de StrasbourgRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Control group
Experimental group
Arm Description
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
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.
Outcomes
Primary Outcome Measures
Measurement of the angle of elevation of the head of patients with invasive mechanical ventilation
Secondary Outcome Measures
Full Information
NCT ID
NCT03687177
First Posted
September 25, 2018
Last Updated
September 25, 2018
Sponsor
University Hospital, Strasbourg, France
1. Study Identification
Unique Protocol Identification Number
NCT03687177
Brief Title
Visual Cue as Prevention of Pulmonary Infection Under Mechanical Ventilation
Acronym
PREVIP
Official Title
Visual Cue as Prevention of Pulmonary Infection Under Mechanical Ventilation
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Unknown status
Study Start Date
September 20, 2018 (Actual)
Primary Completion Date
October 22, 2019 (Anticipated)
Study Completion Date
October 22, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Strasbourg, France
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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). 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Infection
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
180 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
Other
Arm Description
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
Arm Title
Experimental group
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
With visual cue and nurses informed
Intervention Description
Using visual cue or no visual cue with to estimate the angle of elevation of the head of intubated patients with prevention of nurse
Intervention Type
Other
Intervention Name(s)
Without visual cue and nurses informed
Intervention Description
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
Primary Outcome Measure Information:
Title
Measurement of the angle of elevation of the head of patients with invasive mechanical ventilation
Time Frame
3 times a day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
- Patient admitted to intensive care with invasive mechanical ventilation more than two days
Exclusion Criteria:
Pregnancy
Spinal trauma
Brain trauma
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sylvie L'HOTELLIER
Phone
03.88.12.79.14
Ext
033
Email
sylvie.l'hotellier@chru-strasbourg.fr
Facility Information:
Facility Name
Hôpitaux Universitaires de Strasbourg
City
Strasbourg
ZIP/Postal Code
67000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sylvie L'Hotellier
Phone
03.88.12.79.14
Email
sylvie.l'hotellier@chru-strasbourg.fr
12. IPD Sharing Statement
Learn more about this trial
Visual Cue as Prevention of Pulmonary Infection Under Mechanical Ventilation
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