Evaluation of an Analgosedation Protocol in Mechanically Ventilated Patients

NCT ID: NCT02100735

Last Updated: 2020-10-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-13

Study Completion Date

2021-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Sedation protocol

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

Group Type EXPERIMENTAL

Sedation protocol

Intervention Type OTHER

Nursing driven sedation protocol

Standard of care

Current practices

Group Type ACTIVE_COMPARATOR

Sedation protocol

Intervention Type OTHER

Nursing driven sedation protocol

Interventions

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Sedation protocol

Nursing driven sedation protocol

Intervention Type OTHER

Other Intervention Names

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The sedation protocol is a document that wil lbe used by healthcare providers to guide sedation used in the ICU

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tampa General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Beatrice Adams

Pharmacotherapy Specialist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Beatrice Adams

Riverview, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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Pro00016830

Identifier Type: -

Identifier Source: org_study_id

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