Semirecumbent Position by Mechanical Ventilation

Compliance of Recommended Semirecumbent Position in Ventilated Patients

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°.

Study Overview

• Status: Unknown
• Conditions: Compliance, Treatment; Ventilator Associated Pneumonia; Mechanical Ventilation Complication
• Intervention / Treatment: Device: simple blind observation

Detailed Description

A Semirecumbent-bed position in mechanical ventilated patients is recommended in every international guidelines in order to avoiding Ventilator Associated Pneumonia (VAP). Despite being a simple and cheap measure, the literature describe a low compliance. Globally, every intensive care unit tends to use different maneuvers that help or improve compliance of this recommendation. However, there are multiple factors in daily work that hinder compliance. Before taking actions, it would be convenient to know the current state of the unit.

Investigators aim to evaluate the quality with which the recommendation is carried out in the unit in order to maintain a semirecumbent position. To conduct the Trial it will be used a device that measures continuously (every 5 minutes) the angle of the bed without giving any information to caregivers. Once patients are extubated the data will be collected.

• Study Type: Observational
• Enrollment (Anticipated): 30

Contacts and Locations

• Study Contact: Name: Marcos Delgado; Phone Number: +41326273820; Email: marcos.delgado@spital.so.ch

Study Locations

• Switzerland
  • Solothurn, Switzerland, 4500
    • Recruiting
    • Bürgerspital Solothurn
    • Contact: Marcos Delgado, Doctor; Phone Number: +41786724377; Email: marcos.delgado@spital.so.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 99 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

We aim to include every mechanical ventilated patients any reason.

Description

Inclusion Criteria:

• Every ventilated patients

Exclusion Criteria:

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
Demographic and disease characteristics of involved patients.	November 2019 to April 2020

Collaborators and Investigators

• Sponsor: Bürgerspital Solothurn

Publications and helpful links

General Publications

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

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 11, 2020
• Primary Completion (ACTUAL): January 15, 2020
• Study Completion (ANTICIPATED): August 15, 2020

Study Registration Dates

• First Submitted: October 31, 2019
• First Submitted That Met QC Criteria: November 1, 2019
• First Posted (ACTUAL): November 4, 2019

Study Record Updates

• Last Update Posted (ACTUAL): June 16, 2020
• Last Update Submitted That Met QC Criteria: June 13, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia; Lung Diseases; Disease Attributes; Cross Infection; Iatrogenic Disease; Healthcare-Associated Pneumonia; Pneumonia, Ventilator-Associated
• Other Study ID Numbers: Req-2019-01052

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No