ClinicalTrials.gg
Status unknownNCT04149665Updated Jun 16, 2020

Semirecumbent Position by Mechanical Ventilation

An observational study in Mechanical Ventilation Complication, Ventilator Associated Pneumonia and Compliance, Treatment, sponsored by Bürgerspital Solothurn. Status unknown at 1 site in Switzerland. Open to participants aged 19 Years to 99 Years. Per ClinicalTrials.gov, last updated 2020-06-16.

Sponsored by Bürgerspital Solothurn · Observational

The sponsor has not verified this record recently (last verified Jun 2020), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
30
Ages
19 Years to 99 Years
Sex
All
01

Study 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°.

Read the 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.

02

Conditions studied

  • Mechanical Ventilation Complication
  • Ventilator Associated Pneumonia
  • Compliance, Treatment
03

In context

Pneumonia, Ventilator-Associated

420 studies on the registry are indexed under Pneumonia, Ventilator-Associated; 85 are open to participants now.

This study's planned enrollment of 30 is below the median of 170 across 132 observational studies indexed under Pneumonia, Ventilator-Associated.

Browse Pneumonia, Ventilator-Associated studies →

Lead sponsor

Bürgerspital Solothurn is the lead sponsor of 5 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
19 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

We aim to include every mechanical ventilated patients any reason.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Every ventilated patients

Exclusion criteria

Exclusion Criteria:

  • Patients excluded are those lower that 18 years old or neurocritical patients that require flat position.
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
30 participants (estimated)
Target follow-up
6 Months
Patient registry
Yes

Interventions

  • Devicesimple blind observation

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

06

What researchers measure

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°.

    Time frame: November 2019 to April 2020

Secondary outcomes

  1. Demographic and disease characteristics of involved patients.

    Time frame: November 2019 to April 2020

07

Study locations

1 of 1 sites recruiting
  • Bürgerspital Solothurn
    Solothurn, 4500, Switzerland
    Recruiting
08

References and documents

Publications

  • Kollef MH. Ventilator-associated pneumonia. A multivariate analysis. JAMA. 1993 Oct 27;270(16):1965-70. PubMed 8411554 ↗
  • 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. PubMed 23093247 ↗
  • 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. PubMed 10584721 ↗
  • 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. PubMed 16424720 ↗
  • 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. PubMed 19327314 ↗
  • 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. PubMed 7637145 ↗

Individual participant data

Plan to share: No

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2020 to primary completion in Jan 2020, 0 months.

Of 63 non-industry observational studies under Pneumonia, Ventilator-Associated, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 38. This study's 0 months is below that.

Counting every sponsor, half of 63 studies reached it within 20 months; a quarter within 12 and three quarters within 38.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 31, 2019
First posted
Nov 4, 2019
StartActual
Jan 11, 2020
Primary completionActual
Jan 15, 2020
CompletionEst.
Aug 15, 2020
Last update
Jun 16, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 16, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04149665
Lead sponsor
Bürgerspital Solothurn
Responsible party
Marcos Delgado (Principal investigator, Bürgerspital Solothurn) — Principal investigator
First posted
Nov 4, 2019
Start date
Jan 11, 2020
Primary completion
Jan 15, 2020
Completion
Aug 15, 2020 (estimated)
Last update
Jun 16, 2020

Study contacts

Marcos Delgado
Contact
marcos.delgado@spital.so.ch
+41326273820

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.

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