Acute Conditions in Intensive CarePREVENIRNCT02881645
Prevention of Critical Incidents Related to the Nursing With Patients in Intensive Care Units
An observational study of Acute Conditions in Intensive Care, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
The purpose of this study is to assess the effectiveness of a best practices nursing protocol in intensive care units on the occurrence of critical incidents compared to the common practices. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Conditions in Intensive Care
- What is being tested?
- Best practices
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 59,400 participants
- Where
- 1 siteFrance
- Study dates
- 6 May 2019to Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients in intensive care units
Who may be able to join
- Patient in intensive care units
- Patient who has received complete information on the organization of the research and who has not objected to his participation and the exploitation of his data
Who cannot join
- Moribund patients
- Nursing made in the chair or in the shower stretcher
- Patient able to wash and dress alone (or just with the assistance of a nurse)
- Person under legal protection
- Person deprived of liberty by a judicial or administrative decision
- Person being the object of psychiatric care by virtue of articles L. 3212-1 and L. 3213-1 of the french Code of Public Health
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevention of Critical Incidents Related to the Nursing With Patients in Intensive Care Units PREVENIR Study.
The purpose of this study is to assess the effectiveness of a best practices nursing protocol in intensive care units on the occurrence of critical incidents compared to the common practices.
Read the detailed description
To develop the best practices nursing protocol in intensive care units, three steps were necessary:
- An incidence study of occurrence of critical incidents linked to nursing was conducted during a month in nine intensive care units to identify high risk clinical situations
- A qualitative study (individual interviews and focus groups) with nurses was led to elicit nurse's risk anticipatory strategies during nursing
- Based on the results of the two previous step, a working group proposed a best nursing practices protocol to limit critical incidents
Methodology to assess the effectiveness of the protocol of best nursing practices:
The statistical unit is the nursing act for one patient meeting the inclusion criteria (a patient is nursed two times or more per day) Nine intensive care units are included in the study Intensive care units includes 127 beds, their average occupancy rate is approximately 80 % which means about 330 nursing a day and about 9900 nursing a month.
An occurrence of critical incidents (primary outcome measure) of 25% is expected (approximately 2475 critical incidents per month). To show a reduction of 50% of critical incidents in the interventional group, 6 month inclusion will be necessary, whatever the value of the inflation coefficient.
The patient will be under observation during 60 min if a critical incident occurs. And only during nursing if no critical incident occurs.
Data will be collected at bedside.
Patients will be included for the entire duration of the hospitalization in intensive care unit, if inclusion criteria are still met.
Data collection:
- Characteristics of the intensive care unit
- Characteristics of the patient
- Characteristics of the nurse
- Characteristics of the medical equipment of the patient
- Physiological parameters before, during and after nursing (see primary outcome measures)
The best nursing practices protocol will be consider as efficient if a reduction of 50% of critical incident can be established.
Statistical analysis will be in the intent-to-treat.
Hospitals as part of qualitative policy request a declaration of each critical incident. This circus of declaration will not be changed.
- Conditions
- Acute Conditions in Intensive Care
- Being tested
- Best practices
- Keywords
- Intensive care units, Nursing Care, Critical incidents, Best practices
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Best practicesBehavioural
Nurses in intensive care units will be trained to the best practices protocol for a period of two-month preceding the trial
| Study group | Role | What they receive |
|---|---|---|
| Best practices | Assessment of critical incidents linked to nursing with a best practices protocol Receives: Behavioral: Best practices | |
| Common practices | Assessment of critical incidents linked to nursing in common practices |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of critical incidents linked to nursing
The need to call a doctor Or the presence of three failures (desaturation, desadaptation, hypotension, hypertension, bradycardia, tachycardia, cardiac rhythm disorder, Pain) Or one failure persisting more than 60 min Or accidental remove of invasive equipment during nursing Or death
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2016 (estimated)
- Study start6 May 2019
- Primary completionDec 2019 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Conditions in Intensive CareStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 59,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martine LESNY, Principal investigator, CHRU NANCY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02881645
- Sponsor's protocol ID
- PHRIP 2013/PREVENIR-LESNY/NK
- Acronym
- PREVENIR
- Status last verified
- Jun 2019
- First submitted
- 24 Aug 2016
- Last updated
- 10 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Lesny M, Conrad M, Latarche C, Sylvestre A, Gaujard E, Dubois V, Quignard C, Citro V, Thomas JC, Bridey C, Weber AM, Simon C, Klein S, Gibot S, Bollaert PE. Adverse events during nursing care procedure in intensive care unit: The PREVENIR study. Intensive Crit Care Nurs. 2020 Oct;60:102881. doi: 10.1016/j.iccn.2020.102881. Epub 2020 Jun 1.
PubMed 32499089
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Critical Incidents Related to the Nursing With Patients in Intensive Care Units PREVENIR Study.
- ClinicalTrials.gov ID
- NCT02881645
- Acronym / sponsor ID
- PREVENIR / PHRIP 2013/PREVENIR-LESNY/NK
- Conditions
- Acute Conditions in Intensive Care
- Keywords
- Intensive care units, Nursing Care, Critical incidents, Best practices
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 59,400 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 6 May 2019 (actual)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 29 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the effectiveness of a best practices nursing protocol in intensive care units on the occurrence of critical incidents compared to the common practices.
Detailed description
To develop the best practices nursing protocol in intensive care units, three steps were necessary:
- An incidence study of occurrence of critical incidents linked to nursing was conducted during a month in nine intensive care units to identify high risk clinical situations
- A qualitative study (individual interviews and focus groups) with nurses was led to elicit nurse's risk anticipatory strategies during nursing
- Based on the results of the two previous step, a working group proposed a best nursing practices protocol to limit critical incidents
Methodology to assess the effectiveness of the protocol of best nursing practices:
The statistical unit is the nursing act for one patient meeting the inclusion criteria (a patient is nursed two times or more per day) Nine intensive care units are included in the study Intensive care units includes 127 beds, their average occupancy rate is approximately 80 % which means about 330 nursing a day and about 9900 nursing a month.
An occurrence of critical incidents (primary outcome measure) of 25% is expected (approximately 2475 critical incidents per month). To show a reduction of 50% of critical incidents in the interventional group, 6 month inclusion will be necessary, whatever the value of the inflation coefficient.
The patient will be under observation during 60 min if a critical incident occurs. And only during nursing if no critical incident occurs.
Data will be collected at bedside.
Patients will be included for the entire duration of the hospitalization in intensive care unit, if inclusion criteria are still met.
Data collection:
- Characteristics of the intensive care unit
- Characteristics of the patient
- Characteristics of the nurse
- Characteristics of the medical equipment of the patient
- Physiological parameters before, during and after nursing (see primary outcome measures)
The best nursing practices protocol will be consider as efficient if a reduction of 50% of critical incident can be established.
Statistical analysis will be in the intent-to-treat.
Hospitals as part of qualitative policy request a declaration of each critical incident. This circus of declaration will not be changed.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Best practices | – | Behavioral: Best practicesAssessment of critical incidents linked to nursing with a best practices protocol |
| Common practices | – | –Assessment of critical incidents linked to nursing in common practices |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients in intensive care units
Key inclusion criteria (2 listed)
- Patient in intensive care units
- Patient who has received complete information on the organization of the research and who has not objected to his participation and the exploitation of his data
Key exclusion criteria (6 listed)
- Moribund patients
- Nursing made in the chair or in the shower stretcher
- Patient able to wash and dress alone (or just with the assistance of a nurse)
- Person under legal protection
- Person deprived of liberty by a judicial or administrative decision
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Best practicesNurses in intensive care units will be trained to the best practices protocol for a period of two-month preceding the trial | Behavioural | Best practices |
Primary outcome
Proportion of critical incidents linked to nursing
Time frame: 6 month
The need to call a doctor Or the presence of three failures (desaturation, desadaptation, hypotension, hypertension, bradycardia, tachycardia, cardiac rhythm disorder, Pain) Or one failure persisting more than 60 min Or accidental remove of invasive equipment during nursing Or death
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2019.
- Derived from this study: PubMed 32499089Lesny M, Conrad M, Latarche C, Sylvestre A, Gaujard E, Dubois V, Quignard C, Citro V, Thomas JC, Bridey C, Weber AM, Simon C, Klein S, Gibot S, Bollaert PE. Adverse events during nursing care procedure in intensive care unit: The PREVENIR study. Intensive Crit Care Nurs. 2020 Oct;60:102881. doi: 10.1016/j.iccn.2020.102881. Epub 2020 Jun 1.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martine LESNY principal investigator
CHRU NANCY
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Conditions in Intensive Care, run by Central Hospital, Nancy, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Martine LESNY (00 33 3 83 85 19 89, m.lesny@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of critical incidents linked to nursing (time frame: 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02881645, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2019.