NCT02100735

Brief Summary

The purpose of this study is to evaluate how the investigators provide sedation (medicine that make you sleepy) in the investigators intensive care unit (ICU). This study will look at a new way of using sedation in the ICU to see what effect it has on patients and if it decreases the amount of time spent on mechanical ventilation (machine that breathes for you), and in the ICU.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2019

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 21, 2014

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 1, 2014

Completed
5.5 years until next milestone

Study Start

First participant enrolled

September 13, 2019

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2021

Completed
Last Updated

October 19, 2020

Status Verified

October 1, 2020

Enrollment Period

1.6 years

First QC Date

March 21, 2014

Last Update Submit

October 15, 2020

Conditions

Effect of Protocolized Sedation on Days of Mechanical Ventilation in the ICU

Keywords

sedativesanalgesicsprotocolmechanical ventilationanalgosedation

Outcome Measures

Primary Outcomes (1)

  • Days on mechanical ventilation

    Participants will be assessed daily for the duration of their stay in the ICU, an expected average of 4-5 days

Secondary Outcomes (2)

  • ICU Length of stay

    Participants will be followed for the entire length of their ICU stay, expected average of 4-7 days

  • 28 day mortality

    Participants will be followed for 28 days from enrollment into the study

Study Arms (2)

Sedation protocol

EXPERIMENTAL

Sedation protocol is a document that will be used to guide the adjustment of sedation in the ICU.

Other: Sedation protocol

Standard of care

ACTIVE COMPARATOR

Current practices

Other: Sedation protocol

Interventions

Sedation protocolOTHER

Nursing driven sedation protocol

Also known as: The sedation protocol is a document that wil lbe used by healthcare providers to guide sedation used in the ICU
Sedation protocolStandard of care

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients 18 years of age and older
  • Patients expected to require mechanical ventilation for greater than 48 hrs

You may not qualify if:

  • Need for continuous neuromuscular blockade
  • Severe chronic neurocognitive dysfunction
  • Tracheostomy at the time of study enrollment
  • Alcohol withdrawal risk or symptoms
  • Drug overdose
  • Chronic use of narcotics
  • Active seizures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beatrice Adams

Riverview, Florida, 33569, United States

Location
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Pharmacotherapy Specialist

Study Record Dates

First Submitted

March 21, 2014

First Posted

April 1, 2014

Study Start

September 13, 2019

Primary Completion

April 1, 2021

Study Completion

April 1, 2021

Last Updated

October 19, 2020

Record last verified: 2020-10

Locations

US(1)