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

Study Overview
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Brief Summary
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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.

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

Conditions
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Nursing Caries, Critical Care

Intervention / Treatment
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* Procedure: Nursing care


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort for nursing care<br>Patients in ICU under oxygen and/or mechanical ventilation and/or vasoactive drugs and/or non-invasive ventilation | Procedure: Nursing care<br>* The nursing care will be defined as a lateral mobibization and a length of care superior or equal to 10 min<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of occurrence of at least one serious avderse event (SAE) (defined below) during the nursing care while the study period (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 | 72 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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critical care