Semirecumbent Position by Mechanical Ventilation

Mechanical Ventilation Complication Clinical Trial

Official title:

Compliance of Recommended Semirecumbent Position in Ventilated Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04149665
• Other study ID #: Req-2019-01052
• Status: Recruiting
• Start date: January 11, 2020
• Est. completion date: August 15, 2020

Study information

• Verified date: June 2020
• Source: Bürgerspital Solothurn
• Contact: Marcos Delgado
• Phone: +41326273820
• Email: marcos.delgado[@]spital.so.ch
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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°.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: August 15, 2020
• Est. primary completion date: January 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 99 Years

Eligibility

Inclusion Criteria:

• Every ventilated patients

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Compliance, Treatment
• Mechanical Ventilation Complication
• Pneumonia
• Pneumonia, Ventilator-Associated
• Ventilator Associated Pneumonia

Intervention

Device:
• simple blind observation
Device that measures continuously the angle of bed by mechanical Ventilation to assess the time the bed is above 35°.

Locations

Country	Name	City	State
Switzerland	Bürgerspital Solothurn	Solothurn

Sponsors (1)

Lead Sponsor	Collaborator
Bürgerspital Solothurn

Country where clinical trial is conducted

Switzerland, 

References & Publications (6)

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. — View Citation

Deye N, Lellouche F, Maggiore SM, Taillé 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. — View Citation

Drakulovic MB, Torres A, Bauer TT, Nicolas JM, Nogué 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. — View Citation

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

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. — View Citation

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) St — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Demographic and disease characteristics of involved patients.		November 2019 to April 2020