Condition category
Respiratory
Date applied
15/03/2012
Date assigned
29/03/2012
Last edited
12/08/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and aims
Lung collapse occurs when the positive pressure drops in mechanically ventilated patients with acute respiratory failure. The aim in this study is to investigate whether a short, routine disconnection to change the bacterial filter in a mechanical ventilator circle would affect lung function.

Who can participate?
Critically ill and mechanical ventilated patients who are admitted to an intensive care unit and are above 18 years of age.

What does the study involve?
All participants will receive the same treatment. Before a routine filter change, blood pressure and pulse rate will be registered and a blood sample will be drawn. One hour and fifteen minutes after the filter change the same measurements will be repeated.

What are the possible benefits and risks of participating?
Since this study examines the effect of a routine procedure, no risk (more than in the normal routine care) exists. There are no direct benefits, but participation in the study could lead to gained knowledge in the field of respiratory care. It is also possible that the gained knowledge could help future intensive care patients.

Where is the study run from?
Uppsala Academic Hospital, Sweden

When is the study starting and how long is it expected to run for?
The study will be open to participants from approximately February 2011 until January 2013.

Who is funding the study?
Local hospital grants

Who is the main contact?
Mr Joakim Engström
joakim.engstorm@akademiska.se

Trial website

Contact information

Type

Scientific

Primary contact

Prof Anders Larsson

ORCID ID

Contact details

Department of Anesthesiology and Intensive Care Medicine
Uppsala University
Akademiska sjukhuset
ANIVA Ing70
1 tr
Uppsala
75185
Sweden

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Routinely ventilator disconnection on critically ill patients - effect on oxygenation and lung function. A clinical observational study in the intensive care unit at Uppsala University Hospital

Acronym

Study hypothesis

Even a short disconnection from a ventilator during a daily change of a High-Efficiency Particulate Air (HEPA) filter may cause deterioration of lung function in critically ill patients.

Aim:
To test this hypothesis with the primary end-point of lung function expressed by oxygenation and compliance in a clinical prospective observational study in an intensive care unit (ICU) at Uppsala University Hospital.

Ethics approval

Regional Ethical Review Board in Uppsala [Regionala etikprövningsnämnden i Uppsala], 09/12/2010, ref: 2010/317

Study design

Single-centre prospective observational study with consecutive inclusion

Primary study design

Observational

Secondary study design

Cross sectional study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

http://www.physix.se:1080/forskning/disc_studyinfo.pdf [Swedish]

Condition

Critically ill patients with an acute respiratory failure treated with mechanically ventilation.

Intervention

Twenty patients admitted to the intensive care unit will be consecutively enrolled in this clinical prospective observational study. The study is approved by the Regional Ethical Review Board in Uppsala, Sweden. Informed consent will be obtained from the next in kin before measurements is made.
Before the routinely filter change tidal volume [Vt], respiratory rate, end-inspiratory plateau pressure [EIP] and PEEP (Positive End Expiratory Pressure, will be registered. Compliance of the respiratory system (Crs) will be calculated as VT/(EIP-PEEP). Both EIP and PEEP is measured after a prolonged pause of 10 seconds. A decrease of Crs could suggest that lung collapse has occurred. The fraction of inspired oxygen [FiO2], blood pressure and pulse rate will be registered and an arterial blood gas sample for determination of PaO2, PaCO2, pH and BE will be drawn from the patient. A decrease in PaO2 could also suggest that lung collapse has occurred. Fifteen minutes and one hours after the filter change the same measurements will be repeated.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

The difference in PaO2 (kPa) between baseline, 15 minutes and 60 minutes after the HEPA filter change.

Secondary outcome measures

The difference in pulmonary compliance between baseline, 15 minutes and 60 minutes after the HEPA filter change.

Overall trial start date

14/02/2011

Overall trial end date

01/01/2013

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients with respiratory failure treated in the ICU with controlled mechanical ventilatory support
2. Need for fraction of inspired oxygen ≥ 0.5 and positive end expiratory pressure ≥ 10 cmH2O

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

The aim is to include 20 patients

Participant exclusion criteria

1. Patients with spontaneous mechanical ventilatory treatment, patients without an arterial access, 2. Patients without an informed consent from next of kin
3. Pregnant patients
4. Patients under the age of 18
5. Patients that do not meet the inclusion criteria

Recruitment start date

14/02/2011

Recruitment end date

01/01/2013

Locations

Countries of recruitment

Sweden

Trial participating centre

Uppsala University
Uppsala
75185
Sweden

Sponsor information

Organisation

Uppsala University Hospital (Sweden)

Sponsor details

Akademiska sjukhuset
Uppsala
75185
Sweden

Sponsor type

Hospital/treatment centre

Website

http://www.uas.se/

Funders

Funder type

Hospital/treatment centre

Funder name

Uppsala University Hospital - Akademiska Sjukhuset (Sweden)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24282318

Publication citations

Additional files

Editorial Notes