Visual Cue as Prevention of Pulmonary Infection Under Mechanical Ventilation (PREVIP)

September 25, 2018 updated by: University Hospital, Strasbourg, France
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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

- Patient admitted to intensive care with invasive mechanical ventilation more than two days

Exclusion Criteria:

  • Pregnancy
  • Spinal trauma
  • Brain trauma

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Control group
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
Other: Without visual cue and nurses informed
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
Other: Experimental group
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.
Other: With visual cue and nurses informed
Using visual cue or no visual cue with to estimate the angle of elevation of the head of intubated patients with prevention of nurse

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Measurement of the angle of elevation of the head of patients with invasive mechanical ventilation
Time Frame: 3 times a day
3 times a day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Strasbourg, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 20, 2018

Primary Completion (Anticipated)

October 22, 2019

Study Completion (Anticipated)

October 22, 2019

Study Registration Dates

First Submitted

September 25, 2018

First Submitted That Met QC Criteria

September 25, 2018

First Posted (Actual)

September 27, 2018

Study Record Updates

Last Update Posted (Actual)

September 27, 2018

Last Update Submitted That Met QC Criteria

September 25, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6793

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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