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WithdrawnNCT02100735Updated Oct 19, 2020

Evaluation of an Analgosedation Protocol in Mechanically Ventilated Patients

An interventional study of Sedation protocol in Effect of Protocolized Sedation on Days of Mechanical Ventilation in the ICU, sponsored by Tampa General Hospital. Withdrawn at 1 site in United States. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2020-10-19.

Sponsored by Tampa General Hospital · Not applicable, Interventional, and Health services research

Why this study was withdrawn
Difficulty in with enrollment of patient
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years to 100 Years
Sex
All
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Study 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.

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Conditions studied

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

Keywords

  • sedatives
  • analgesics
  • protocol
  • mechanical ventilation
  • analgosedation
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In context

Lead sponsor

Tampa General Hospital is the lead sponsor of 11 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
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Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Sedation protocol

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

    Other: Sedation protocol

  • Active comparator
    Standard of care

    Current practices

    Other: Sedation protocol

Interventions

  • OtherSedation protocol

    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

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What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. ICU Length of stay

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

  2. 28 day mortality

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

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Study locations

1 site
  • Beatrice Adams
    Riverview, Florida 33569, United States
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 19, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02100735
Lead sponsor
Tampa General Hospital
Responsible party
Beatrice Adams (Pharmacotherapy Specialist, Tampa General Hospital) — Principal investigator
First posted
Apr 1, 2014
Start date
Sep 13, 2019
Primary completion
Apr 2021 (estimated)
Completion
Apr 2021 (estimated)
Last update
Oct 19, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.

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