NCT04149665

Brief Summary

It's based in an observational trial in mechanical ventilated patients. The investigators assess the head of bed elevation angle in the routine treatment of the unit. The investigators decide to assess the time the patient has a semirecumbent position \>35°.

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
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2020

Shorter than P25 for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 31, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 4, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

January 11, 2020

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2020

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2020

Completed
Last Updated

June 16, 2020

Status Verified

June 1, 2020

Enrollment Period

4 days

First QC Date

October 31, 2019

Last Update Submit

June 13, 2020

Conditions

Mechanical Ventilation ComplicationVentilator Associated PneumoniaCompliance, Treatment

Outcome Measures

Primary Outcomes (1)

  • Compliance of semirecumbent position in mechanical ventilated patients

    Assess how long are mechanical ventilated patient with a head of bed elevation above 35°.

    November 2019 to April 2020

Secondary Outcomes (1)

  • Demographic and disease characteristics of involved patients.

    November 2019 to April 2020

Interventions

simple blind observationDEVICE

Device that measures continuously the angle of bed by mechanical Ventilation to assess the time the bed is above 35°.

Eligibility Criteria

Age19 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

We aim to include every mechanical ventilated patients any reason.

You may qualify if:

  • Every ventilated patients

You may not qualify if:

  • Patients excluded are those lower that 18 years old or neurocritical patients that require flat position.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bürgerspital Solothurn

Solothurn, 4500, Switzerland

RECRUITING

Related Publications (6)

  • Kollef MH. Ventilator-associated pneumonia. A multivariate analysis. JAMA. 1993 Oct 27;270(16):1965-70.

    PMID: 8411554BACKGROUND

  • Deye N, Lellouche F, Maggiore SM, Taille S, Demoule A, L'Her E, Galia F, Harf A, Mancebo J, Brochard L. The semi-seated position slightly reduces the effort to breathe during difficult weaning. Intensive Care Med. 2013 Jan;39(1):85-92. doi: 10.1007/s00134-012-2727-5. Epub 2012 Oct 24.

    PMID: 23093247BACKGROUND

  • Drakulovic MB, Torres A, Bauer TT, Nicolas JM, Nogue S, Ferrer M. Supine body position as a risk factor for nosocomial pneumonia in mechanically ventilated patients: a randomised trial. Lancet. 1999 Nov 27;354(9193):1851-8. doi: 10.1016/S0140-6736(98)12251-1.

    PMID: 10584721BACKGROUND

  • van Nieuwenhoven CA, Vandenbroucke-Grauls C, van Tiel FH, Joore HC, van Schijndel RJ, van der Tweel I, Ramsay G, Bonten MJ. Feasibility and effects of the semirecumbent position to prevent ventilator-associated pneumonia: a randomized study. Crit Care Med. 2006 Feb;34(2):396-402. doi: 10.1097/01.ccm.0000198529.76602.5e.

    PMID: 16424720BACKGROUND

  • Alexiou VG, Ierodiakonou V, Dimopoulos G, Falagas ME. Impact of patient position on the incidence of ventilator-associated pneumonia: a meta-analysis of randomized controlled trials. J Crit Care. 2009 Dec;24(4):515-22. doi: 10.1016/j.jcrc.2008.09.003. Epub 2009 Feb 13.

    PMID: 19327314BACKGROUND

  • Vincent JL, Bihari DJ, Suter PM, Bruining HA, White J, Nicolas-Chanoin MH, Wolff M, Spencer RC, Hemmer M. The prevalence of nosocomial infection in intensive care units in Europe. Results of the European Prevalence of Infection in Intensive Care (EPIC) Study. EPIC International Advisory Committee. JAMA. 1995 Aug 23-30;274(8):639-44.

    PMID: 7637145RESULT

MeSH Terms

Conditions

Pneumonia, Ventilator-AssociatedPatient Compliance

Condition Hierarchy (Ancestors)

Healthcare-Associated PneumoniaCross InfectionInfectionsPneumoniaRespiratory Tract InfectionsLung DiseasesRespiratory Tract DiseasesIatrogenic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Central Study Contacts

Marcos Delgado

CONTACT

+41326273820marcos.delgado@spital.so.ch

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

October 31, 2019

First Posted

November 4, 2019

Study Start

January 11, 2020

Primary Completion

January 15, 2020

Study Completion

August 15, 2020

Last Updated

June 16, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)