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Clinical Trials/NCT03475238
NCT03475238
Completed
Not Applicable

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

French Society for Intensive Care26 sites in 4 countries262 target enrollmentMarch 29, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Nursing Caries
Sponsor
French Society for Intensive Care
Enrollment
262
Locations
26
Primary Endpoint
Incidence of occurrence of at least one serious avderse event (SAE) (defined below) during the nursing care while the study period (72 hours)
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 29, 2018
End Date
February 13, 2019
Last Updated
7 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
French Society for Intensive Care
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

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

Study Sites (26)

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