Condition category
Respiratory
Date applied
14/05/2012
Date assigned
06/06/2012
Last edited
06/06/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and aims
Intensive care is often a life saving process in critically ill patients. In this condition even a slight change in physiological status could have severe effects. Nursing procedures such as changing the patient's position and removal of secretions from the airways are essential to prevent side effects like pressure sores, contractures (loss of joint motion) and hospital-acquired infections.
Nursing procedures may have adverse effects like changes in blood pressure or accidental awakening that may worsen the critically ill patients’ condition. These procedures are not well investigated to date. Therefore we intend to carry out this study in an attempt to evaluate a potential common problem during intensive care.

Who can participate?
To take part you need to be:
1. Critically ill and mechanical ventilated.
2. Be admitted to an intensive care unit.
3. Aged above 18 years.

What does the study involve?
The study protocol is strictly observational and therefore no intervention will be performed. A researcher not included in the regular care will observe the participant during a twelve-hour period from 06 AM to 06 PM. All observed adverse effects, procedures causing the adverse effects and any interventions that follows an adverse effect will be recorded by the researcher.

What are the possible benefits and risks of participating?
Since this study examines the effect of routine procedures, no added risk exists. There are no direct benefits, but participation in the study could lead to improved knowledge in the field of intensive care. It is also possible that the knowledge gained could help future intensive care patients.

Where is the study run from?
The study is run from Uppsala Academic Hospital.

When is study starting and how long is it expected to run for?
The study will be open to participants, from approximately June 2012 until December 2013.

Who is funding the study?
This study is being funded by Uppsala County Council.

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

Trial website

Contact information

Type

Scientific

Primary contact

Prof Anders Larsson

ORCID ID

Contact details

Uppsala University
Department of Anesthesiology and Intensive Care Medicine
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

Adverse effects of nursing procedures in critically ill patients - improving or impairing patient health? A clinical observational study in the intensive care unit at Uppsala University Hospital

Acronym

Study hypothesis

Critically ill patients in the intensive care unit suffer from adverse effects during nursing routine procedures (e.g. endotracheal suctioning, position change etcetera).

The aim of the study is to investigate this hypothesis with the primary end-point of alternation in consciousness, respiratory and circulatory parametric changes.

1. Is there any adverse effects from nursing routine procedures in critically ill patients in the intensive care unit?
2. What kinds of adverse effects are there and how often do they occur?

Ethics approval

Regional Ethical Review Board, Uppsala [Regionala etikprövningsnämnden i Uppsala], 15 June 2011, ref: 2011/151.

Study design

Single-centre prospective observational study with consecutive inclusion

Primary study design

Observational

Secondary study design

Non randomised controlled trial

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

Patient information material can be found at www.physix.se/forskning/ae_studyinfo.pdf (Swedish)

Condition

Critically ill patients with an acute respiratory failure treated with mechanical ventilation

Intervention

Sixteen patients admitted to the intensive care unit will be consecutively enrolled in this clinical observational study. Informed consent will be obtained from the next in kin before measurements are made.

The observational session will start at 06.00 AM and proceed for 12 hours. The scientist will not be included in the regular care. The patient will only be included once. Under the 12-hour period the scientist will record all nursing procedures and if any adverse effects occur, time, type of adverse effect and any intervention to reduce the adverse effect will also be recorded. The observational protocol will not record any personal data of the medical or nursing staff.

Data that will be collected in the study protocol is changes in tidal volume [Vt], respiratory rate [RR], end-inspiratory plateau pressure [EIP], SpO2, blood pressure, pulse rate and RASS [Richmond Agitation Sedation Scale].

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Are there any adverse effects from nursing routine procedures (e.g. endotracheal suctioning, position change, etc) in critically ill patients at an intensive care unit?

Secondary outcome measures

What kind of adverse effects are there and how often do they occur?

Overall trial start date

01/06/2012

Overall trial end date

31/12/2013

Reason abandoned

Eligibility

Participant inclusion criteria

1. All patients with respiratory failure treated in the Intensive care unit (ICU) with controlled mechanical ventilatory support
2. Need of fraction of inspired oxygen ≥ 0.45 and positive end expiratory pressure ≥ 8 cmH2O
3. Need of vasoactive drugs (norepinephrine ≥ 0.05 µg/kg/min)
4. Not fulfilling any of the exclusion criteria

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

The aim is to include 16 patients.

Participant exclusion criteria

1. Patients without an intra-arterial access
2. Patients without an informed consent from next of kin
3. Patients with limitation of treatment
4. Pregnant patients
5. Patients under the age of 18

Recruitment start date

01/06/2012

Recruitment end date

31/12/2013

Locations

Countries of recruitment

Sweden

Trial participating centre

Uppsala University
Uppsala
75185
Sweden

Sponsor information

Organisation

Uppsala County Council (Sweden)

Sponsor details

Box 602
Uppsala
S-75125
Sweden

Sponsor type

Government

Website

http://www.uas.se/templates/page____43080.aspx

Funders

Funder type

Government

Funder name

Uppsala County Council (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

Publication citations

Additional files

Editorial Notes