NCT03687177

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 20, 2018

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

September 25, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 27, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 22, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 22, 2019

Completed
Last Updated

September 27, 2018

Status Verified

September 1, 2018

Enrollment Period

1.1 years

First QC Date

September 25, 2018

Last Update Submit

September 25, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Measurement of the angle of elevation of the head of patients with invasive mechanical ventilation

    3 times a day

Study Arms (2)

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

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.

Other: With visual cue and nurses informed

Interventions

Using visual cue or no visual cue with to estimate the angle of elevation of the head of intubated patients with prevention of nurse

Experimental group

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

Control group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Pregnancy
  • Spinal trauma
  • Brain trauma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpitaux Universitaires de Strasbourg

Strasbourg, 67000, France

RECRUITING

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 25, 2018

First Posted

September 27, 2018

Study Start

September 20, 2018

Primary Completion

October 22, 2019

Study Completion

October 22, 2019

Last Updated

September 27, 2018

Record last verified: 2018-09

Locations