Analysis of Factors Related to Occurrence of Serious Adverse Events During Nursing in Intensive Care Units (NURSIE)
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| ClinicalTrials.gov Identifier: NCT03475238 |
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Recruitment Status :
Completed
First Posted : March 23, 2018
Last Update Posted : February 15, 2019
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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.
| Condition or disease | Intervention/treatment |
|---|---|
| Nursing Caries Critical Care | Procedure: Nursing care |
| Study Type : | Observational |
| Actual Enrollment : | 262 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Nursing Research on the Occurrence of Serious Adverse Events in Intensive Care Unit During Bed Bath and Nursing Care. NURSIE Study |
| Actual Study Start Date : | March 29, 2018 |
| Actual Primary Completion Date : | July 15, 2018 |
| Actual Study Completion Date : | February 13, 2019 |
| Group/Cohort | Intervention/treatment |
|---|---|
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Cohort for nursing care
Patients in ICU under oxygen and/or mechanical ventilation and/or vasoactive drugs and/or non-invasive ventilation
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Procedure: Nursing care
The nursing care will be defined as a lateral mobibization and a length of care superior or equal to 10 min |
- 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
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| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Each participating unit will include all consecutive patients staying in the ICU.
Each day a screening of the patients will be released between 8 and 10 am.
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03475238
Show 26 study locations
| Study Director: | Mathieu Lloung | French Intensive Care Society | |
| Study Chair: | Jean Baptiste Lascarrou, MD | French Intensive Care Society |
| Responsible Party: | French Society for Intensive Care |
| ClinicalTrials.gov Identifier: | NCT03475238 |
| Other Study ID Numbers: |
2018-A00046-49 |
| First Posted: | March 23, 2018 Key Record Dates |
| Last Update Posted: | February 15, 2019 |
| Last Verified: | February 2019 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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critical care |