Analysis of Factors Related to Occurrence of Serious Adverse Events During Nursing in Intensive Care Units

Patients who are hospitalized in intensive care unit (ICU) require basic nursing care to improve patient hygiene, to promote comfort, to prevent pressure ulcer, and foot or hand's retractations.

Those nursing cares require mobilization very frequently which expose critically ill patients to occurrence of serious adverse events (SAE) such as i) hemodynamic, neurologic, and respiratory variations ii) unplanned dislodgement (lines, drains, catheters, endotracheal tube..)

Few study have evaluated relation between SAE occurence and several patient's, service's, health-care provider's caracteristics. We plan to analyse those factors to find some ways to prevent SAE occurence during nursing and hygiene cares.

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Key information

Conditions

Nursing Caries Critical Care

Sex eligibility

All sexes

Study type

Observational

Primary location

Hopital de Bruxelles, Brussels, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Health-care affiliated
Length of ICU stay < 72 h
Patient with endotracheal tube
Patient with tracheostomy
Patient receiving vasoactives drugs (norepinephrine, epinephrine, Dobutamine)
Patient undergoing no invasive ventilation during 1hour minimum of 24 hours before the selection
Patient undergoing hight flow oxygen therapy heated and humidified

Exclusion criteria

Patient already included in this study
Medical contraindication to the bed bath with lateral mobilization
Withdrawal of life sustaining treatment
Spinal trauma

Treatment and study plan

Nursing care

Procedure

The nursing care will be defined as a lateral mobibization and a length of care superior or equal to 10 min

Primary outcomes

Incidence of occurrence of at least one serious avderse event (SAE) (defined below) during the nursing care while the study period (72 hours)

Time frame: 72 hours
Determinate incidence of occurrence of at least one SAE (defined below) during the nursing care while the study period (72 hours) The nursing care will be defined as a lateral mobibization and a length of care sup or equal to 10min

SAE are considered according to litterature as :
- Cardiac arest
- Unplanned extubation
- Episode of Spo2 riequiring therapeutic intervention
- Artificial airway obstruction requiring endotracheal suctionning
- Unplanned dislodgements related to lines or catheters drains
- Hypotension with therapeutic intervention
- Cardiac rhythm disorders with therapeutic intervention
- Agitation with therapeutic intervention
- Equipment failure or dysfunction
- Patient fall
- Need for doctor help
- Increased intracranial pressure > 20 mmHg
- Acute painful crisis

Sponsors and collaborators

Lead sponsor

French Society for Intensive Care

Other

Registry information

Official study title

Nursing Research on the Occurrence of Serious Adverse Events in Intensive Care Unit During Bed Bath and Nursing Care. NURSIE Study

Acronym: NURSIE

Important dates

Study start: 2018
Primary completion: 2018
Study completion: 2019
First posted: Mar 23, 2018
Registry last updated: Feb 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed