Effect of nursing procedures in critically ill patients - improving or impairing patient health?

ISRCTN ISRCTN73736539
DOI https://doi.org/10.1186/ISRCTN73736539
Secondary identifying numbers N/A
Submission date
14/05/2012
Registration date
06/06/2012
Last edited
21/01/2019
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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

Contact information

Prof Anders Larsson
Scientific

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

Study information

Study designSingle-centre prospective observational study with consecutive inclusion
Primary study designObservational
Secondary study designNon randomised controlled trial
Study setting(s)Hospital
Study typeQuality of life
Participant information sheet Patient information material can be found at www.physix.se/forskning/ae_studyinfo.pdf (Swedish)
Scientific titleAdverse 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
Study objectivesCritically 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(s)Regional Ethical Review Board, Uppsala [Regionala etikprövningsnämnden i Uppsala], 15 June 2011, ref: 2011/151.
Health condition(s) or problem(s) studiedCritically ill patients with an acute respiratory failure treated with mechanical ventilation
InterventionSixteen 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 typeOther
Primary outcome measureAre 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 measuresWhat kind of adverse effects are there and how often do they occur?
Overall study start date01/06/2012
Completion date31/12/2013

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participantsThe aim is to include 16 patients.
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment01/06/2012
Date of final enrolment31/12/2013

Locations

Countries of recruitment

  • Sweden

Study participating centre

Uppsala University
Uppsala
75185
Sweden

Sponsor information

Uppsala County Council (Sweden)
Government

Funders

Funder type

Government

Uppsala County Council (Sweden)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/01/2017 18/01/2019 Yes No

Editorial Notes

18/01/2019: Publication reference added