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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03687177
Other study ID # 6793
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 20, 2018
Est. completion date October 22, 2019

Study information

Verified date September 2018
Source University Hospital, Strasbourg, France
Contact Sylvie L'HOTELLIER
Phone 03.88.12.79.14
Email sylvie.l'hotellier@chru-strasbourg.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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). 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 180
Est. completion date October 22, 2019
Est. primary completion date October 22, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

- Pregnancy

- Spinal trauma

- Brain trauma

Study Design


Related Conditions & MeSH terms


Intervention

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
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

Locations

Country Name City State
France Hôpitaux Universitaires de Strasbourg Strasbourg

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Measurement of the angle of elevation of the head of patients with invasive mechanical ventilation 3 times a day
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