Simulation for Continuous Veno-venous Hemofiltration in Intensive caRe

NCT02379234 | Completed

• 1 other identifier: 49RC13_0209
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

Brief Summary

Continuous Veno-Veinous Hemofiltration (CVVH) is a frequently used renal replacement therapy in intensive care units for patients with acute renal failure. In theory, this therapy should be continuous, 24 hours/day. However, it is wellknown that actual duration of CVVH sessions is much lower than scheduled, with frequent "circuit down-times" (between 1 to 6 hours/day). There are many reasons for premature ending of CVVH sessions (i.e. catheter dysfunction, wrong settings, low anticoagulation…), but early detection of any dysfunction may prevent (at least in part) the CVVH circuit coagulation. ICU Nurses are on the first line to manage CVVH sessions, particularly in case of alarms. High-fidelity simulation has been recently proposed for health care provider education. It has been consistently associated with large effects for outcomes of knowledge, skills, and behaviors but with moderate effects for patient related outcomes. Indeed, few studies have assess the impact of simulation on patient outcome following complexe procedures, that implies team work in addition to individual skills. In our 12-bed surgical ICU, investigators have decided to implement CVVH technics (in addition to the dialysis that we already used). Before implementing this new technic in the ICU, investigators designed this study in order assess wether a high-fidelity based ICU-nurses education program would improve the outcome of CVVH sessions, compared to the conventional education program, proposed by the CVVH manufacturer.

Conditions

Hemofiltration; Nurse Training; Health Care Provider Education

Keywords

CVVH; Renal replacement therapy; High fidelity simulation; Nurse training

Outcome Measures

Primary Outcomes (1)

• percentage of CVVH sessions ended prematurely as measured by a percentage

  Two years

Secondary Outcomes (3)

• Management of CVVH generator alarms during the sessions as measured by the number of 'calling for help' during the session

  72 hours

• efficacy of CVVH session measured by creatinine and bilirubin rate

  72 hours

• Evaluation of nurses satisfaction measured by a quiz

  72 hours

Study Arms (2)

Control

NO INTERVENTION

All nurses received a 4 hours formation, called "conventional formation", given by a professional trainer, that included 2 hours of theorical formation and 2 hours of practical training, based on CVVH generator demonstration. In addition, the trainer was present in the ICU during the first week of CVVH implementation, to answer any questions and to help nurses with their first CVVH sessions

Simulated

EXPERIMENTAL

The 'Simulated formation',used high fidelity mannequin and CVVH generator, is composed of 3 training sessions of 2 hours each one. This formation is associated with the 'conventional formation'.

Other: simulation

Interventions

simulation OTHER

Nurses received, in addition to the conventional formation (as in the control arm), a set of 3 high-fidelity simulation sessions. Each session lasted 1 to 2 hours, used high fidelity mannequin and CVVH generator and took place in an ICU room environment. For each session, a specific scenario was designed, the session began with a briefing and ended with a debriefing, based on video recording.

Simulated

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- All ICU-nurses were recruited.

You may not qualify if:

• \- None

Sponsors & Collaborators

• University Hospital, Angers: lead

Study Sites (1)

Pr Lasocki Sigismond

Angers, 49000, France

Location

Related Publications (1)

• Lemarie P, Husser Vidal S, Gergaud S, Verger X, Rineau E, Berton J, Parot-Schinkel E, Hamel JF, Lasocki S. High-Fidelity Simulation Nurse Training Reduces Unplanned Interruption of Continuous Renal Replacement Therapy Sessions in Critically Ill Patients: The SimHeR Randomized Controlled Trial. Anesth Analg. 2019 Jul;129(1):121-128. doi: 10.1213/ANE.0000000000003581.

  PMID: 29933269 RESULT

Study Officials

• Sigismond Lasocki

  University Hospital, Angers

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: We performed a 2-phase (training and evaluation), randomized, single-center, open study: During the training phase, intensive care unit nurses underwent a 6-hour training pro- gram and were randomized to receive (intervention) or not (control) an additional high-fidelity simulation training (6 hours). During the evaluation phase, management of CRRT sessions was randomized to either intervention or control nurses.

Study Record Dates

• First Submitted: February 12, 2015
• First Posted: March 4, 2015
• Study Start: January 1, 2014
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: November 17, 2020

Record last verified: 2020-11

Locations

FR (1)