Analysis of Factors Related to Occurrence of Serious Adverse Events During Nursing in Intensive Care Units
NCT ID: NCT03475238
Last Updated: 2019-02-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
262 participants
OBSERVATIONAL
2018-03-29
2019-02-13
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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
Nursing care
The nursing care will be defined as a lateral mobibization and a length of care superior or equal to 10 min
Interventions
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Nursing care
The nursing care will be defined as a lateral mobibization and a length of care superior or equal to 10 min
Eligibility Criteria
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Inclusion Criteria
* 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
* Medical contraindication to the bed bath with lateral mobilization
* Withdrawal of life sustaining treatment
* Spinal trauma
ALL
No
Sponsors
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French Society for Intensive Care
OTHER
Responsible Party
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Principal Investigators
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Mathieu Lloung
Role: STUDY_DIRECTOR
French Intensive Care Society
Jean Baptiste Lascarrou, MD
Role: STUDY_CHAIR
French Intensive Care Society
Locations
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Hopital de Bruxelles
Brussels, , Belgium
CHU Charleroi
Charleroi, , Belgium
Hopital Civil Marie Curie
Charleroi, , Belgium
CH Andre Migniot
Versailles, A, France
CHU Besançon
Besançon, , France
CHU Ambroise Paré
Boulogne-Billancourt, , France
CH Sud Francilien
Corbeil-Essonnes, , France
CH de Dax
Dax, , France
CH de la Dracénie
Draguignan, , France
CHRU Lille
Lille, , France
Hopital Jeanne De Flandre
Lille, , France
CHU Marseille
Marseille, , France
CHU Nantes
Nantes, , France
CHU Nice
Nice, , France
CHU Nimes
Nîmes, , France
CHR Orléans
Orléans, , France
CHU La Pitié Salpétrière
Paris, , France
CHU Lariboisière
Paris, , France
CHU Necker Enfant Malade
Paris, , France
Hopital Europeen George Pompidou
Paris, , France
CHU Strasbourg
Strasbourg, , France
CHU Toulouse
Toulouse, , France
CH Valence
Valence, , France
CHI Lucie & Raymond Aubrac
Villeneuve-Saint-Georges, , France
Centre Hospitalier Emile Mayrisch
Luxembourg, , Luxembourg
Hopital de la Tour
Meyrin, , Switzerland
Countries
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Other Identifiers
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2018-A00046-49
Identifier Type: -
Identifier Source: org_study_id
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