DeliriumNCT03840577

BIS-Guided Sedation in Critically Ill Patients Under Deep Sedation

A study testing Monitorization of sedation by Bispectral Index in people with Delirium and Sedative Overdose, run by Hospital Italiano de Buenos Aires at 1 site in Argentina.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

Search all trials

Trial summary

The goal of this clinical trial is to investigate the effectiveness of sedation guided by the bispectral index (BIS) in reducing the incidence of delirium and the doses of sedative drugs used in critical patients who require deep sedation. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Delirium, Sedative Overdose
What is being tested?: Monitorization of sedation by Bispectral Index
Type of treatment: Injection or infusion, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 99 participants
Where: 1 siteArgentina
Study dates: 1 Apr 2019to 1 Jan 2024
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients older than 18 years.
Under mechanical ventilation in the intensive care unit
Indication of deep sedation (RASS objective -4, -5)
Admission to the ICU or indication of deep sedation up to 8 hours prior to randomization.

Who cannot join

Patients with end-of-life care.
Family refusal to participate in the study.
Impossibility to place the BIS sensor (burns, extensive lesions on the forehead, prone position, etc.).
Patients with intracranial hypertension or convulsive status, in whom sedation has the objective of suppressing electroencephalographic waves.
Patients who, following a decrease in sedation, have a coma, vegetative state or a state of minimal consciousness.

Trial locations and contacts

1 site in 1 country.

Argentina1 site

Hospital Italiano de Buenos Aires
Capital Federal, 1173

Other trials in Argentina

About this study

Official title: Effect of Bispectral Index (BIS)-Guided Sedation on Delirium and Sedative Drug Requirements in Critically Ill Patients Under Deep Sedation

Does sedation guided by BIS lead to higher delirium and coma-free days compared to clinical monitoring?
Does sedation guided by BIS result in reduced doses of sedative drugs compared to clinical monitoring?

Participants in this study will be randomly assigned to one of two groups:

Clinical Monitoring Group: Participants in this group will receive sedation based on clinical scales. These participants will also be fitted with a BIS sensor, but the sensor will be covered.

Sedation Guided by BIS Group: Participants in this group will receive sedation guided by the bispectral index.

The study will be conducted as a prospective, controlled, blind intervention trial with random distribution and intention to treat. The primary outcomes to be evaluated include:

Delirium and coma-free days after the end of deep sedation using the Confusion Assessment Method for the ICU (CAM-ICU) scale.
Total dose of sedative drugs administered.
BIS values

Researchers will compare the two groups to determine if sedation guided by BIS is associated with a higher number of delirium and coma-free days, reduced sedative drug doses, and higher values of BIS compared to clinical monitoring.

Read the detailed description

A Phase 4, randomized (1:1), controlled, double-blind, unicenter clinical trial aims to assess the effectiveness of sedation guided by the Bispectral Index (BIS) compared to sedation guided by clinical scales in critically ill patients under deep sedation. The primary objective is to investigate whether BIS-guided sedation can reduce the incidence of delirium and decrease the doses of sedative drugs administered.

Conditions: Delirium, Sedative Overdose
Being tested: Monitorization of sedation by Bispectral Index
Keywords: Deep Sedation, Bispectral index, Critical care patients, Delirium, Sedatives
Medical subject headings: Delirium

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Monitorization of sedation by Bispectral IndexDevice
The sedative dose administered through a continuous infusion pump will be adjusted based on the BIS value to maintain a target range of 40 to 60. If the BIS value is below the target range, the dose will be increased, and if it exceeds the range, the dose will be decreased, aiming to keep the BIS within the desired range.

Study groups in NCT03840577
Study group	Role	What they receive
Sedation guided by Clinical Scales	No intervention	Sedative guided by RASS (Richmond Agitation-Sedation Scale) score. Target RASS: -4 / -5.
Sedation guided by Bispectral Index	Experimental	Sedation guided by the Bispectral Index (BIS). Target BIS between 40 to 60. Receives: Device: Monitorization of sedation by Bispectral Index

What is being measured

The primary outcome is the main question the study is designed to answer.

Compare delirium and coma free days until 14 days after end of deep sedation
To compare the number of Delirium and Coma-Free Days until day 14 after the cessation of deep sedation in patients receiving sedation guided by the Bispectral Index (BIS) vs. sedation guided by clinical scales. Delirium will be assessed using the CAM-ICU scale (Ely EW et al.) by non-ICU researchers who are blinded to the randomization allocation. The delirium evaluation will begin when the patient reaches a Richmond Agitation-Sedation Scale (RASS) score of > -3.
Measured: Up to 14 days post end of deep sedation
Compare the doses of sedative drugs received
To compare the total doses of Propofol, Midazolam, and Remifentanil (calculated in mg/kg) received during the period of deep sedation
Measured: From date of randomization until the date of end of deep sedation or date of death from any cause, whichever came first, assessed up to 90 days
Compare values of BIS
To compare the values of Bispectral Index (BIS) in patients receiving sedation guided by the Bispectral Index (BIS) versus sedation guided by clinical scales. This outcome will assess the BIS values recorded during the period of deep sedation and compare them between the two groups
Measured: From date of randomization until the date of end of deep sedation or date of death from any cause, whichever came first, assessed up to 90 days

Secondary outcomes (6)

Time with values of BIS less than 40
To compare the number of hours that patients receiving sedation guided by the Bispectral Index (BIS) vs. sedation guided by clinical scales had registered Bispectral Index (BIS) values below 40 during the period of deep sedation. The duration of time with BIS values below 40 will be recorded for each patient.
Measured: From date of randomization until the date of end of deep sedation or date of death from any cause, whichever came first, assessed up to 90 days
Compare days alive and free of the ICU
To compare the effect of sedation guided by the Bispectral Index (BIS) vs. sedation guided by clinical scales on days alive and free of the ICU
Measured: From date of randomization until the date of ICU discharge or date of death from any cause, whichever came first, assessed up to 120 days
Compare days alive and free of the hospital
To compare the effect of sedation guided by the Bispectral Index (BIS) vs. sedation guided by clinical scales on days alive and free of the hospital
Measured: From date of randomization until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 120 days
Compare days alive and free of mechanical ventilation through Study Day 30
To compare the effect of sedation guided by the Bispectral Index (BIS) vs. sedation guided by clinical scales on the number of days alive and free of mechanical ventilation through Study Day 30
Measured: From date of randomization until the date of end of mechanical ventilation or date of death from any cause, whichever came first, assessed up to 30 days
Compare days alive and free of mechanical ventilation through Study Day 60
To compare the effect of sedation guided by the Bispectral Index (BIS) vs. sedation guided by clinical scales on the number of days alive and free of mechanical ventilation through Study Day 60
Measured: From date of randomization until the date of end of mechanical ventilation or date of death from any cause, whichever came first, assessed up to 60 days
Compare delirium and coma free days until 14 days after end of deep sedation in patients who had more than 24 hours of deep sedation
To compare the number of Delirium and Coma-Free Days until day 14 after the cessation of deep sedation in patients receiving sedation guided by the Bispectral Index (BIS) vs. sedation guided by clinical scales. Delirium will be assessed using the CAM-ICU scale (Ely EW et al.) by non-ICU researchers who are blinded to the randomization allocation. The delirium evaluation will begin when the patient reaches a Richmond Agitation-Sedation Scale (RASS) score of > -3, in patients who had more than 24 hours of deep sedation
Measured: Up to 14 days post end of deep sedation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Apr 20191 Jan 2024

First posted15 Feb 2019
Study start1 Apr 2019
Primary completion22 Apr 2022
Study completion1 Jan 2024 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (7)Papers the sponsor has linked to this study.
Other trials for DeliriumStudies 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: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Model description: Patients will be assigned according to the randomization to clinical monitoring groups or Bispectral Index (BIS) monitoring group. The ranzomization will be stratified randomization by neuromuscular bloquers.
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 99 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03840577
Sponsor's protocol ID: 3880
Status last verified: Jul 2023
First submitted: 3 Feb 2019
Last updated: 1 Aug 2023
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: Yes: Individual participant data will be made available upon reasonable request.

Publications

MacKenzie KK, Britt-Spells AM, Sands LP, Leung JM. Processed Electroencephalogram Monitoring and Postoperative Delirium: A Systematic Review and Meta-analysis. Anesthesiology. 2018 Sep;129(3):417-427. doi: 10.1097/ALN.0000000000002323.
PubMed 29912008
Salluh JI, Soares M, Teles JM, Ceraso D, Raimondi N, Nava VS, Blasquez P, Ugarte S, Ibanez-Guzman C, Centeno JV, Laca M, Grecco G, Jimenez E, Arias-Rivera S, Duenas C, Rocha MG; Delirium Epidemiology in Critical Care Study Group. Delirium epidemiology in critical care (DECCA): an international study. Crit Care. 2010;14(6):R210. doi: 10.1186/cc9333. Epub 2010 Nov 23.
PubMed 21092264
Ely EW, Margolin R, Francis J, May L, Truman B, Dittus R, Speroff T, Gautam S, Bernard GR, Inouye SK. Evaluation of delirium in critically ill patients: validation of the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU). Crit Care Med. 2001 Jul;29(7):1370-9. doi: 10.1097/00003246-200107000-00012.
PubMed 11445689
Devlin JW, Skrobik Y, Gelinas C, Needham DM, Slooter AJC, Pandharipande PP, Watson PL, Weinhouse GL, Nunnally ME, Rochwerg B, Balas MC, van den Boogaard M, Bosma KJ, Brummel NE, Chanques G, Denehy L, Drouot X, Fraser GL, Harris JE, Joffe AM, Kho ME, Kress JP, Lanphere JA, McKinley S, Neufeld KJ, Pisani MA, Payen JF, Pun BT, Puntillo KA, Riker RR, Robinson BRH, Shehabi Y, Szumita PM, Winkelman C, Centofanti JE, Price C, Nikayin S, Misak CJ, Flood PD, Kiedrowski K, Alhazzani W. Clinical Practice Guidelines for the Prevention and Management of Pain, Agitation/Sedation, Delirium, Immobility, and Sleep Disruption in Adult Patients in the ICU. Crit Care Med. 2018 Sep;46(9):e825-e873. doi: 10.1097/CCM.0000000000003299.
PubMed 30113379
Sessler CN, Gosnell MS, Grap MJ, Brophy GM, O'Neal PV, Keane KA, Tesoro EP, Elswick RK. The Richmond Agitation-Sedation Scale: validity and reliability in adult intensive care unit patients. Am J Respir Crit Care Med. 2002 Nov 15;166(10):1338-44. doi: 10.1164/rccm.2107138.
PubMed 12421743
Shetty RM, Bellini A, Wijayatilake DS, Hamilton MA, Jain R, Karanth S, Namachivayam A. BIS monitoring versus clinical assessment for sedation in mechanically ventilated adults in the intensive care unit and its impact on clinical outcomes and resource utilization. Cochrane Database Syst Rev. 2018 Feb 21;2(2):CD011240. doi: 10.1002/14651858.CD011240.pub2.
PubMed 29464690
Huespe I, Giunta D, Acosta K, Avila D, Prado E, Sanghavi D, Bisso IC, Giannasi S, Carini FC. Comparing Bispectral Index Monitoring vs Clinical Assessment for Deep Sedation in the ICU: Effects on Delirium Reduction and Sedative Drug Doses-A Randomized Trial. Chest. 2024 Oct;166(4):733-742. doi: 10.1016/j.chest.2024.05.031. Epub 2024 Jun 18.
PubMed 38901489

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Neurosurgery, Brain Cancer
RecruitingPhase 3
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Not yet recruitingObservational study
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All Delirium trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Bispectral Index (BIS)-Guided Sedation on Delirium and Sedative Drug Requirements in Critically Ill Patients Under Deep Sedation
ClinicalTrials.gov ID: NCT03840577
Acronym / sponsor ID: 3880
Conditions: Delirium, Sedative Overdose
Keywords: Deep Sedation, Bispectral index, Critical care patients, Delirium, Sedatives
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 99 participants (actual)
Lead sponsor: Hospital Italiano de Buenos AiresUniversity, hospital or other
Study start: 1 Apr 2019 (actual)
Primary completion: 22 Apr 2022 (actual)
Study completion: 1 Jan 2024 (estimated)
First posted: 15 Feb 2019 (actual)
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.

Does sedation guided by BIS lead to higher delirium and coma-free days compared to clinical monitoring?
Does sedation guided by BIS result in reduced doses of sedative drugs compared to clinical monitoring?

Participants in this study will be randomly assigned to one of two groups:

Clinical Monitoring Group: Participants in this group will receive sedation based on clinical scales. These participants will also be fitted with a BIS sensor, but the sensor will be covered.

Sedation Guided by BIS Group: Participants in this group will receive sedation guided by the bispectral index.

The study will be conducted as a prospective, controlled, blind intervention trial with random distribution and intention to treat. The primary outcomes to be evaluated include:

Delirium and coma-free days after the end of deep sedation using the Confusion Assessment Method for the ICU (CAM-ICU) scale.
Total dose of sedative drugs administered.
BIS values

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2
Model description: Patients will be assigned according to the randomization to clinical monitoring groups or Bispectral Index (BIS) monitoring group. The ranzomization will be stratified randomization by neuromuscular bloquers.

Arm	Type	Receives
Sedation guided by Clinical Scales	No intervention	–Sedative guided by RASS (Richmond Agitation-Sedation Scale) score. Target RASS: -4 / -5.
Sedation guided by Bispectral Index	Experimental	Device: Monitorization of sedation by Bispectral IndexSedation guided by the Bispectral Index (BIS). Target BIS between 40 to 60.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Patients older than 18 years.
Under mechanical ventilation in the intensive care unit
Indication of deep sedation (RASS objective -4, -5)
Admission to the ICU or indication of deep sedation up to 8 hours prior to randomization.

Key exclusion criteria (5 listed)

Patients with end-of-life care.
Family refusal to participate in the study.
Impossibility to place the BIS sensor (burns, extensive lesions on the forehead, prone position, etc.).
Patients with intracranial hypertension or convulsive status, in whom sedation has the objective of suppressing electroencephalographic waves.
Patients who, following a decrease in sedation, have a coma, vegetative state or a state of minimal consciousness.

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
Monitorization of sedation by Bispectral IndexThe sedative dose administered through a continuous infusion pump will be adjusted based on the BIS value to maintain a target range of 40 to 60. If the BIS value is below the target range, the dose will be increased, and if it exceeds the range, the dose will be decreased, aiming to keep the BIS within the desired range.	Device	Sedation guided by Bispectral Index

Primary outcome

Compare delirium and coma free days until 14 days after end of deep sedation
Time frame: Up to 14 days post end of deep sedation
To compare the number of Delirium and Coma-Free Days until day 14 after the cessation of deep sedation in patients receiving sedation guided by the Bispectral Index (BIS) vs. sedation guided by clinical scales. Delirium will be assessed using the CAM-ICU scale (Ely EW et al.) by non-ICU researchers who are blinded to the randomization allocation. The delirium evaluation will begin when the patient reaches a Richmond Agitation-Sedation Scale (RASS) score of > -3.
Compare the doses of sedative drugs received
Time frame: From date of randomization until the date of end of deep sedation or date of death from any cause, whichever came first, assessed up to 90 days
To compare the total doses of Propofol, Midazolam, and Remifentanil (calculated in mg/kg) received during the period of deep sedation
Compare values of BIS
Time frame: From date of randomization until the date of end of deep sedation or date of death from any cause, whichever came first, assessed up to 90 days
To compare the values of Bispectral Index (BIS) in patients receiving sedation guided by the Bispectral Index (BIS) versus sedation guided by clinical scales. This outcome will assess the BIS values recorded during the period of deep sedation and compare them between the two groups

6 secondary outcomes

Time with values of BIS less than 40
Time frame: From date of randomization until the date of end of deep sedation or date of death from any cause, whichever came first, assessed up to 90 days
Compare days alive and free of the ICU
Time frame: From date of randomization until the date of ICU discharge or date of death from any cause, whichever came first, assessed up to 120 days
Compare days alive and free of the hospital
Time frame: From date of randomization until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 120 days
Compare days alive and free of mechanical ventilation through Study Day 30
Time frame: From date of randomization until the date of end of mechanical ventilation or date of death from any cause, whichever came first, assessed up to 30 days
Compare days alive and free of mechanical ventilation through Study Day 60
Time frame: From date of randomization until the date of end of mechanical ventilation or date of death from any cause, whichever came first, assessed up to 60 days
Compare delirium and coma free days until 14 days after end of deep sedation in patients who had more than 24 hours of deep sedation
Time frame: Up to 14 days post end of deep sedation

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2023.
Background: PubMed 29912008MacKenzie KK, Britt-Spells AM, Sands LP, Leung JM. Processed Electroencephalogram Monitoring and Postoperative Delirium: A Systematic Review and Meta-analysis. Anesthesiology. 2018 Sep;129(3):417-427. doi: 10.1097/ALN.0000000000002323.
Background: PubMed 21092264Salluh JI, Soares M, Teles JM, Ceraso D, Raimondi N, Nava VS, Blasquez P, Ugarte S, Ibanez-Guzman C, Centeno JV, Laca M, Grecco G, Jimenez E, Arias-Rivera S, Duenas C, Rocha MG; Delirium Epidemiology in Critical Care Study Group. Delirium epidemiology in critical care (DECCA): an international study. Crit Care. 2010;14(6):R210. doi: 10.1186/cc9333. Epub 2010 Nov 23.
Background: PubMed 11445689Ely EW, Margolin R, Francis J, May L, Truman B, Dittus R, Speroff T, Gautam S, Bernard GR, Inouye SK. Evaluation of delirium in critically ill patients: validation of the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU). Crit Care Med. 2001 Jul;29(7):1370-9. doi: 10.1097/00003246-200107000-00012.
Background: PubMed 30113379Devlin JW, Skrobik Y, Gelinas C, Needham DM, Slooter AJC, Pandharipande PP, Watson PL, Weinhouse GL, Nunnally ME, Rochwerg B, Balas MC, van den Boogaard M, Bosma KJ, Brummel NE, Chanques G, Denehy L, Drouot X, Fraser GL, Harris JE, Joffe AM, Kho ME, Kress JP, Lanphere JA, McKinley S, Neufeld KJ, Pisani MA, Payen JF, Pun BT, Puntillo KA, Riker RR, Robinson BRH, Shehabi Y, Szumita PM, Winkelman C, Centofanti JE, Price C, Nikayin S, Misak CJ, Flood PD, Kiedrowski K, Alhazzani W. Clinical Practice Guidelines for the Prevention and Management of Pain, Agitation/Sedation, Delirium, Immobility, and Sleep Disruption in Adult Patients in the ICU. Crit Care Med. 2018 Sep;46(9):e825-e873. doi: 10.1097/CCM.0000000000003299.
Background: PubMed 12421743Sessler CN, Gosnell MS, Grap MJ, Brophy GM, O'Neal PV, Keane KA, Tesoro EP, Elswick RK. The Richmond Agitation-Sedation Scale: validity and reliability in adult intensive care unit patients. Am J Respir Crit Care Med. 2002 Nov 15;166(10):1338-44. doi: 10.1164/rccm.2107138.
Background: PubMed 29464690Shetty RM, Bellini A, Wijayatilake DS, Hamilton MA, Jain R, Karanth S, Namachivayam A. BIS monitoring versus clinical assessment for sedation in mechanically ventilated adults in the intensive care unit and its impact on clinical outcomes and resource utilization. Cochrane Database Syst Rev. 2018 Feb 21;2(2):CD011240. doi: 10.1002/14651858.CD011240.pub2.
Derived from this study: PubMed 38901489Huespe I, Giunta D, Acosta K, Avila D, Prado E, Sanghavi D, Bisso IC, Giannasi S, Carini FC. Comparing Bispectral Index Monitoring vs Clinical Assessment for Deep Sedation in the ICU: Effects on Delirium Reduction and Sedative Drug Doses-A Randomized Trial. Chest. 2024 Oct;166(4):733-742. doi: 10.1016/j.chest.2024.05.031. Epub 2024 Jun 18.
Individual participant dataSharing planned: Yes. Individual participant data will be made available upon reasonable request.

Related trials for Delirium

Active, not recruitingPhase 3
The Danish Out-of-Hospital Cardiac Arrest Study
Out-Of-Hospital Cardiac Arrest, Post-Cardiac Arrest Syndrome
Not yet recruiting
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Not yet recruiting
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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.

Sergio Giannasi, MD study chair

Hospital Italiano de Buenos Aires

Federico Carini, MD study director

Hospital Italiano de Buenos Aires

Ivan A. Huespe, MD principal investigator

Hospital Italiano de Buenos Aires

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Monitorization of sedation by Bispectral Index in people with Delirium and Sedative Overdose, run by Hospital Italiano de Buenos Aires at 1 site in Argentina.

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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 1 Aug 2023. 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 Argentina. 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?

Results are not available in the source record.

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?

Compare delirium and coma free days until 14 days after end of deep sedation (time frame: Up to 14 days post end of deep sedation). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03840577, which also lists 7 linked publications.

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 1 Aug 2023.