Impact of a Nurse Implemented Sedation and Analgesia Algorithm in Surgical Intensive Care Unit

Sedation Clinical Trial

— ALGOSEDA  

Official title:

Impact of a Nurse Implemented Sedation and Analgesia Algorithm on Complications of Critical Illness and Outcome of Surgical Intensive Care Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03186521
• Other study ID #: 15-147
• Status: Recruiting
• Phase: N/A
• First received: June 9, 2017
• Last updated: June 13, 2017
• Start date: December 2014
• Est. completion date: December 2017

Study information

• Verified date: June 2017
• Source: University Hospital, Caen
• Contact: Véronique POTTIER, MD
• Phone: 33231064736
• Email: pottier-v[@]chu-caen.fr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

To show that the nurse implementation of a sedation and analgesia algorithm is beneficial to the patient in terms of sedative drugs reduction and thus overall decrease in duration of mechanical ventilation and the morbidity and mortality which is associated with it, without altering patient comfort and tolerance of the environment. This, compared to the less frequent assessments by doctors and thus regular adjustments during the day as opposed to a fixed drug dose.

Description:

Outcome Measures : The primary objective of this non-invasive, non-interventional study is to show that the establishment of a titration algorithm for sedation and analgesia administered by nurses is more beneficial to the patient than the use of such a drug without a suitable regimen. The goal is to improve the quality of our painkillers and sedative drugs use needed in the intensive care environment in order to decrease the morbidity and mortality associated with it, without altering patient comfort and tolerance to the environment. For this we propose to collect a database including patient demographic details, pharmacological information and any possible complications during the ICU stay as well as a distant assessment exploring the psychological complications (3, 6 months and 1 year). The primary endpoint will be the duration of mechanical ventilation, and secondary endpoints, the length of stay in ICU and in hospital, mortality and other complications.

Methods: The two study populations will be in two distinct time periods, the first so-called control without any modification of practices, and the second, by introducing the algorithm with the same drugs being used. Quantitative comparisons of data following a normal distribution will be done using a Student's t test. Otherwise quantitative data will be compared using a Mann-Whitney test or Wilcoxon. The comparison of qualitative data will be done using a Fisher exact test. To increase the power of this before / after study, we calculated the number of patients to be included by period, based on the reduction in duration of mechanical ventilation with such protocols in the literature, and the mean duration of mechanical ventilation in our unit before the study.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Any patient sedated, intubated, ventilated whose anticipated duration of sedation is more than 48 hours.

• Age greater than 18 years.

Exclusion Criteria:

• Patient under guardianship or <18.

• Comatose, intracranial hypertension, brain damage, Acute respiratory distress syndrom, acute severe asthma (therapeutic sedation), Post Cardiac Arrest care, Pregnancy

• Neuromuscular blocking agents at the time of inclusion

Secondary Exclusion criteria:

• Extubation <48 hours after inclusion

• Deaths <48 hours after inclusion

Related Conditions & MeSH terms

• Sedation

Locations

Country	Name	City	State
France	POTTIER	Caen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of mechanical ventilation	Duration between endotracheale intubation and extubation	baseline