Mechanical VentilationNCT07806188
Dexmedetomidine for Sedation in Patients Requiring Mechanical Ventilation is Associated With a Lower Incidence of Delirium
An observational study of Mechanical Ventilation, run by Sohag University.
Trial summary
This retrospective cohort study will include 412 adults mechanically ventilated >24 hours in intensive care unit in sohag university hospital between 2024 and 2026). Participants will be assigned to either, EGDS group ( equal to 208 ) or conventional sedation group (equal to 204 ). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mechanical Ventilation
- Type of treatment
- Injection or infusion
- How many people
- 412 participants
- Where
- No sites listed yet
- Study dates
- 20 Aug 2026to 20 Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: this retrospective observational trial was conducted in a 40-bed intensive care unit at sohag university hospital between January 2024, to ,march 2026. The Institutional Review Board granted approval for the trial protocol and informed consent was waived
Who may be able to join
- Consecutive adult patients aged 18 years or older who required invasive mechanical ventilation for more than 24 hours.
Who cannot join
- Neurological primary admission such as stroke or traumatic brain injury.
- Active seizures or alcohol withdrawal at admission.
- Prior dementia or severe cognitive impairment.
- Mechanical ventilation <24 hours.
- Death within 48 hours of admission.
- Missing essential sedation or delirium data.
About this study
Official title: Dexmedetomidine for Sedation in Patients Requiring Mechanical Ventilation is Associated With a Lower Incidence of Delirium : A Retrospective Study
This retrospective cohort study will include 412 adults mechanically ventilated >24 hours in intensive care unit in sohag university hospital between 2024 and 2026). Participants will be assigned to either, EGDS group ( equal to 208 ) or conventional sedation group (equal to 204 ). The main endpoint will be measured is the incidence of delirium in ICU , measured by the Confusion Assessment Method for the ICU (CAM-ICU). Secondary endpoints will be the number of the days free from ventilation at 28 days (VFDs), ICU length of stay (LOS) in the ICU, and the death during hospitalization.
- Conditions
- Mechanical Ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| EGDS Group: Patients managed per the institutional EGDS protocol initiated within 12 hours of intuba | · EGDS Group: Patients managed per the institutional EGDS protocol initiated within 12 hours of intubation. The protocol mandated: a) Primary sedative: Dexmedetomidine infusion (loading dose optional, maintenance 0.2-1.5 µg/kg/hr). b) Goal: Target Richmond Agitation-Sedation Scale (RASS) score of 0 to -2. c) Adjunct Analgesia: Scheduled acetaminophen and opioid infusion (e.g., fentanyl) for pain control (CPOT target <3). d) Protocol Deviations: Propofol was allowed as a rescue for refractory agitation (RASS >+2) after optimizing analgesia | |
| Conventional Sedation Group: Patients managed at the discretion of the treating intensivist without | Conventional Sedation Group: Patients managed at the discretion of the treating intensivist without a mandated protocol. This typically involved continuous infusions of propofol and/or midazolam, with or without dexmedetomidine, with variable RASS targets |
What is being measured
The primary outcome is the main question the study is designed to answer.
occurrence of delirium during the ICU admission
main end point: occurrence of delirium during the ICU admission , defined as at least one positive CAM-ICU assessment.
Measured: Within 12 hours of intubation
Secondary outcomes (2)
Number of Ventilator-free days (VFDs)
Measured: 6 months
duration of ICU stay (LOS)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2026
- Study start20 Aug 2026 (estimated)
- Primary completion1 Nov 2026 (estimated)
- Study completion20 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanical VentilationStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 412 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Islam Mokhtar Ahmed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07806188
- Sponsor's protocol ID
- Soh-Med-26-6-16PD
- Status last verified
- Aug 2026
- First submitted
- 24 Aug 2026
- Last updated
- 8 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexmedetomidine for Sedation in Patients Requiring Mechanical Ventilation is Associated With a Lower Incidence of Delirium : A Retrospective Study
- ClinicalTrials.gov ID
- NCT07806188
- Acronym / sponsor ID
- Soh-Med-26-6-16PD
- Conditions
- Mechanical Ventilation
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 412 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 20 Aug 2026 (estimated)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 20 Jan 2027 (estimated)
- First posted
- 8 Sep 2026 (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.
This retrospective cohort study will include 412 adults mechanically ventilated >24 hours in intensive care unit in sohag university hospital between 2024 and 2026). Participants will be assigned to either, EGDS group ( equal to 208 ) or conventional sedation group (equal to 204 ). The main endpoint will be measured is the incidence of delirium in ICU , measured by the Confusion Assessment Method for the ICU (CAM-ICU). Secondary endpoints will be the number of the days free from ventilation at 28 days (VFDs), ICU length of stay (LOS) in the ICU, and the death during hospitalization.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EGDS Group: Patients managed per the institutional EGDS protocol initiated within 12 hours of intuba | – | –· EGDS Group: Patients managed per the institutional EGDS protocol initiated within 12 hours of intubation. The protocol mandated: a) Primary sedative: Dexmedetomidine infusion (loading dose optional, maintenance 0.2-1.5 µg/kg/hr). b) Goal: Target Richmond Agitation-Sedation Scale (RASS) score of 0 to -2. c) Adjunct Analgesia: Scheduled acetaminophen and opioid infusion (e.g., fentanyl) for pain control (CPOT target <3). d) Protocol Deviations: Propofol was allowed as a rescue for refractory agitation (RASS >+2) after optimizing analgesia |
| Conventional Sedation Group: Patients managed at the discretion of the treating intensivist without | – | –Conventional Sedation Group: Patients managed at the discretion of the treating intensivist without a mandated protocol. This typically involved continuous infusions of propofol and/or midazolam, with or without dexmedetomidine, with variable RASS targets |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- this retrospective observational trial was conducted in a 40-bed intensive care unit at sohag university hospital between January 2024, to ,march 2026. The Institutional Review Board granted approval for the trial protocol and informed consent was waived
Key inclusion criteria (1 listed)
- Consecutive adult patients aged 18 years or older who required invasive mechanical ventilation for more than 24 hours.
Key exclusion criteria (6 listed)
- Neurological primary admission such as stroke or traumatic brain injury.
- Active seizures or alcohol withdrawal at admission.
- Prior dementia or severe cognitive impairment.
- Mechanical ventilation <24 hours.
- Death within 48 hours of admission.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
occurrence of delirium during the ICU admission
Time frame: Within 12 hours of intubation
main end point: occurrence of delirium during the ICU admission , defined as at least one positive CAM-ICU assessment.
2 secondary outcomes
Number of Ventilator-free days (VFDs)
Time frame: 6 months
duration of ICU stay (LOS)
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Mechanical Ventilation, run by Sohag University.
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 1 inclusion and 6 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: opening soon, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
occurrence of delirium during the ICU admission (time frame: Within 12 hours of intubation). 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 8 Sep 2026.