Effect of Protocolized Sedation on Days of Mechanical Ventilation in the ICUNCT02100735
Evaluation of an Analgosedation Protocol in Mechanically Ventilated Patients
A study testing Sedation protocol in people with Effect of Protocolized Sedation on Days of Mechanical Ventilation in the ICU, run by Tampa General Hospital at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Effect of Protocolized Sedation on Days of Mechanical Ventilation in the ICU
- What is being tested?
- Sedation protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Sep 2019to Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients 18 years of age and older
- Patients expected to require mechanical ventilation for greater than 48 hrs
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- Sedation protocol
- Keywords
- sedatives, analgesics, protocol, mechanical ventilation, analgosedation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sedation protocolOther
Also called The sedation protocol is a document that wil lbe used by healthcare providers to guide sedation used in the ICU
Nursing driven sedation protocol
| Study group | Role | What they receive |
|---|---|---|
| Sedation protocol | Experimental | Sedation protocol is a document that will be used to guide the adjustment of sedation in the ICU. Receives: Other: Sedation protocol |
| Standard of care | Active comparator | Current practices Receives: Other: Sedation protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Days on mechanical ventilation
Measured: 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
Measured: Participants will be followed for the entire length of their ICU stay, expected average of 4-7 days
28 day mortality
Measured: Participants will be followed for 28 days from enrollment into the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2014 (estimated)
- Study start13 Sep 2019
- Primary completionApr 2021 (estimated)
- Study completionApr 2021 (estimated)
Why it stopped: Difficulty in with enrollment of patient
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Effect of Protocolized Sedation on Days of Mechanical Ventilation in the ICUStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tampa General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Beatrice Adams, Tampa General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02100735
- Sponsor's protocol ID
- Pro00016830
- Status last verified
- Oct 2020
- First submitted
- 21 Mar 2014
- Last updated
- 19 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of an Analgosedation Protocol in Mechanically Ventilated Patients
- ClinicalTrials.gov ID
- NCT02100735
- Acronym / sponsor ID
- Pro00016830
- Keywords
- sedatives, analgesics, protocol, mechanical ventilation, analgosedation
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Difficulty in with enrollment of patient
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Tampa General HospitalUniversity, hospital or other
- Study start
- 13 Sep 2019 (actual)
- Primary completion
- Apr 2021 (estimated)
- Study completion
- Apr 2021 (estimated)
- First posted
- 1 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sedation protocol | Experimental | Other: Sedation protocolSedation protocol is a document that will be used to guide the adjustment of sedation in the ICU. |
| Standard of care | Active comparator | Other: Sedation protocolCurrent practices |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients 18 years of age and older
- Patients expected to require mechanical ventilation for greater than 48 hrs
Key exclusion criteria (7 listed)
- Need for continuous neuromuscular blockade
- Severe chronic neurocognitive dysfunction
- Tracheostomy at the time of study enrollment
- Alcohol withdrawal risk or symptoms
- Drug overdose
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sedation protocolAlso: The sedation protocol is a document that wil lbe used by healthcare providers to guide sedation used in the ICUNursing driven sedation protocol | Other | Sedation protocol, Standard of care |
Primary outcome
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
2 secondary outcomes
ICU Length of stay
Time frame: 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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2020.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sedation protocol in people with Effect of Protocolized Sedation on Days of Mechanical Ventilation in the ICU, run by Tampa General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 19 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2020.