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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03475238
Acronym
NURSIE
Enrollment
262
Registered
2018-03-23
Start date
2018-03-29
Completion date
2019-02-13
Last updated
2019-02-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical Care, Nursing Caries

Keywords

critical care

Brief summary

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.

Interventions

PROCEDURENursing care

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

Sponsors

French Society for Intensive Care
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

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

Countries

Belgium, France, Luxembourg, Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026