Evaluation of an Analgosedation Protocol in Mechanically Ventilated Patients

October 15, 2020 updated by: Beatrice Adams, Tampa General Hospital
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Riverview, Florida, United States, 33569
        • Beatrice Adams

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 96 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sedation protocol
Sedation protocol is a document that will be used to guide the adjustment of sedation in the ICU.
Other: Sedation protocol
Nursing driven sedation protocol
Other Names:
  • The sedation protocol is a document that wil lbe used by healthcare providers to guide sedation used in the ICU
Active Comparator: Standard of care
Current practices
Other: Sedation protocol
Nursing driven sedation protocol
Other Names:
  • The sedation protocol is a document that wil lbe used by healthcare providers to guide sedation used in the ICU

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Days on mechanical ventilation
Time Frame: Participants will be assessed daily for the duration of their stay in the ICU, an expected average of 4-5 days
Participants will be assessed daily for the duration of their stay in the ICU, an expected average of 4-5 days

Secondary Outcome Measures

Outcome Measure
Time Frame
ICU Length of stay
Time Frame: Participants will be followed for the entire length of their ICU stay, expected average of 4-7 days
Participants will be followed for the entire length of their ICU stay, expected average of 4-7 days
28 day mortality
Time Frame: Participants will be followed for 28 days from enrollment into the study
Participants will be followed for 28 days from enrollment into the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tampa General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 13, 2019

Primary Completion (Anticipated)

April 1, 2021

Study Completion (Anticipated)

April 1, 2021

Study Registration Dates

First Submitted

March 21, 2014

First Submitted That Met QC Criteria

March 27, 2014

First Posted (Estimate)

April 1, 2014

Study Record Updates

Last Update Posted (Actual)

October 19, 2020

Last Update Submitted That Met QC Criteria

October 15, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Pro00016830

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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