Mechanical Ventilation ComplicationNCT04149665
Semirecumbent Position by Mechanical Ventilation
An observational study of Mechanical Ventilation Complication and Ventilator Associated Pneumonia, run by Bürgerspital Solothurn at 1 site in Switzerland.
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°. Read more about this study
- Who is it for?
- Ages 19 to 99 years
- Conditions the study is for
- Mechanical Ventilation Complication, Ventilator Associated Pneumonia, Compliance, Treatment
- What is being tested?
- simple blind observation
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteSwitzerland
- Study dates
- 11 Jan 2020to 15 Aug 2020
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: We aim to include every mechanical ventilated patients any reason.
Who may be able to join
- Every ventilated patients
Who cannot join
- Patients excluded are those lower that 18 years old or neurocritical patients that require flat position.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
Bürgerspital Solothurn
Solothurn, 4500
Marcos Delgado, Doctor, +41786724377, marcos.delgado@spital.so.ch
About this study
Official title: 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°.
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.
- Conditions
- Mechanical Ventilation Complication, Ventilator Associated Pneumonia, Compliance, Treatment
- Being tested
- simple blind observation
- Medical subject headings
- Pneumonia, Ventilator-Associated, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
simple blind observationDevice
Device that measures continuously the angle of bed by mechanical Ventilation to assess the time the bed is above 35°.
What is being measured
The primary outcome is the main question the study is designed to answer.
Compliance of semirecumbent position in mechanical ventilated patients
Assess how long are mechanical ventilated patient with a head of bed elevation above 35°.
Measured: November 2019 to April 2020
Secondary outcomes (1)
Demographic and disease characteristics of involved patients.
Measured: November 2019 to April 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2019
- Study start11 Jan 2020
- Primary completion15 Jan 2020
- Study completion15 Aug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Mechanical Ventilation ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Bürgerspital Solothurn
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marcos Delgado, Bürgerspital Solothurn
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04149665
- Sponsor's protocol ID
- Req-2019-01052
- Status last verified
- Jun 2020
- First submitted
- 31 Oct 2019
- Last updated
- 16 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kollef MH. Ventilator-associated pneumonia. A multivariate analysis. JAMA. 1993 Oct 27;270(16):1965-70.
PubMed 8411554Deye 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 23093247Drakulovic 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 10584721van 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 16424720Alexiou 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 19327314Vincent 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
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compliance of Recommended Semirecumbent Position in Ventilated Patients
- ClinicalTrials.gov ID
- NCT04149665
- Acronym / sponsor ID
- Req-2019-01052
- Conditions
- Mechanical Ventilation Complication, Ventilator Associated Pneumonia, Compliance, Treatment
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Bürgerspital SolothurnUniversity, hospital or other
- Study start
- 11 Jan 2020 (actual)
- Primary completion
- 15 Jan 2020 (actual)
- Study completion
- 15 Aug 2020 (estimated)
- First posted
- 4 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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°.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 19 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- We aim to include every mechanical ventilated patients any reason.
Key inclusion criteria (1 listed)
- Every ventilated patients
Key exclusion criteria (1 listed)
- Patients excluded are those lower that 18 years old or neurocritical patients that require flat position.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| simple blind observationDevice that measures continuously the angle of bed by mechanical Ventilation to assess the time the bed is above 35°. | Device | – |
Primary outcome
Compliance of semirecumbent position in mechanical ventilated patients
Time frame: November 2019 to April 2020
Assess how long are mechanical ventilated patient with a head of bed elevation above 35°.
1 secondary outcome
Demographic and disease characteristics of involved patients.
Time frame: November 2019 to April 2020
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2020.
- Background: PubMed 8411554Kollef MH. Ventilator-associated pneumonia. A multivariate analysis. JAMA. 1993 Oct 27;270(16):1965-70.
- Background: PubMed 23093247Deye 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.
- Background: PubMed 10584721Drakulovic 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.
- Background: PubMed 16424720van 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.
- Background: PubMed 19327314Alexiou 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.
- Results publication: PubMed 7637145Vincent 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mechanical Ventilation Complication and Ventilator Associated Pneumonia, run by Bürgerspital Solothurn at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marcos Delgado (+41326273820, marcos.delgado@spital.so.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compliance of semirecumbent position in mechanical ventilated patients (time frame: November 2019 to April 2020). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04149665, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2020.