Mechanically Ventilated Children Admitted to the Pediatric Intensive Care UnitISPMVCNCT07821268
Impact of Sedation Practices on Clinical Outcomes Among Mechanically Ventilated Children
An observational study of Mechanically Ventilated Children Admitted to the Pediatric Intensive Care Unit, run by Yasmine Ahmed Abdelrahman at 1 site in Egypt.
Trial summary
evaluate the impact of sedation adequacy on clinical outcomes in mechanically ventilated children admitted to the pediatric intensive care unit (PICU). Read more about this study
- Who is it for?
- Ages 0 to 18 years
- Conditions the study is for
- Mechanically Ventilated Children Admitted to the Pediatric Intensive Care Unit
- What is being tested?
- no need
- Type of treatment
- Injection or infusion
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2026to 1 Jun 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 0 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children admitted to PICU requiring invasive mechanical ventilation (MV) ≥ 48 hours and received any form of sedation or analgesia during ventilation ≥ 48 hours.
Who may be able to join
- Children admitted to PICU requiring invasive mechanical ventilation (MV) ≥ 48 hours and received any form of sedation or analgesia during ventilation ≥ 48 hours.
Who cannot join
- children ventilated after cardiac arrest
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Sohag University Hospital
Sohag
yasmeen ahmed abdelrhman, 01289750281, Yasmin.Abdelrahman@med.sohag.edu.eg
About this study
Official title: Impact of Sedation Practices on Clinical Outcomes Among Mechanically Ventilated Pediatric Intensive Care Unit Patients
evaluate the impact of sedation adequacy on clinical outcomes in mechanically ventilated children admitted to the pediatric intensive care unit (PICU).
Read the detailed description
evaluate the impact of sedation adequacy on clinical outcomes in mechanically ventilated children admitted to the pediatric intensive care unit (PICU). Sedation is fundamental in the Paediatric Intensive Care Unit (PICU) for mechanically ventilated children, seeking to improve their clinical outcome, enhance ventilator synchronisation, and promote tolerance of invasive procedures. Achieving appropriate sedation is hard, since both under-sedation and over-sedation are linked to negative outcomes, including extended mechanical breathing, heightened risk of ventilator-associated pneumonia
- Being tested
- no need
- Keywords
- Sedation, pediatric intensive care unit, mechanically ventilated pediatric
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no needOther
no need
| Study group | Role | What they receive |
|---|---|---|
| mechanically ventilated children admitted to the pediatric intensive care unit (PICU). | Children aged between 1 months and 18 years of age
• Children admitted to PICU requiring invasive mechanical ventilation (MV) ≥ 48 hours and received any form of sedation or analgesia during ventilation ≥ 48 hours. (e.g., midazolam 4 (loading dose 0.05-0.1 mg/kg IV and maintenance dose 0.03-0.12 mg/kg/hr IV), fentanyl (loading dose 1-2 mcg/kg IV over 10min and maintenance dose 1-4 mcg/kg/hr IV infusion), ketamine (loading dose 0.5-1 mg/kg IV and maintenance dose 0.1-0.5 mg/kg/hr), morphine (loading dose 0.05-0.1 mg/kg IV and maintenance dose 0.05-0.1 mg/kg IV) Receives: Other: no need |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Richmond Agitation-Sedation Scale (RASS)
is a validated 10-point clinical tool used in PICUs to assess patient alertness, agitation, and sedation depth in <20 seconds. In your sedation-outcome study, nurses score RASS every 4-8 hours to classify adequate sedation (target: RASS -2 to 0) vs. under-sedation (>0) or over-sedation (≤-3)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 May 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanically Ventilated Children Admitted to the Pediatric Intensive Care UnitStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yasmine Ahmed Abdelrahman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yasmine Ahmed Abdelrahman, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07821268
- Sponsor's protocol ID
- Soh-Med-26-6-11MS
- Acronym
- ISPMVC
- Status last verified
- Jun 2026
- First submitted
- 9 Sep 2026
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Sedation Practices on Clinical Outcomes Among Mechanically Ventilated Pediatric Intensive Care Unit Patients
- ClinicalTrials.gov ID
- NCT07821268
- Acronym / sponsor ID
- ISPMVC / Soh-Med-26-6-11MS
- Keywords
- Sedation, pediatric intensive care unit, mechanically ventilated pediatric
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Yasmine Ahmed AbdelrahmanUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 15 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.
evaluate the impact of sedation adequacy on clinical outcomes in mechanically ventilated children admitted to the pediatric intensive care unit (PICU).
Detailed description
evaluate the impact of sedation adequacy on clinical outcomes in mechanically ventilated children admitted to the pediatric intensive care unit (PICU). Sedation is fundamental in the Paediatric Intensive Care Unit (PICU) for mechanically ventilated children, seeking to improve their clinical outcome, enhance ventilator synchronisation, and promote tolerance of invasive procedures. Achieving appropriate sedation is hard, since both under-sedation and over-sedation are linked to negative outcomes, including extended mechanical breathing, heightened risk of ventilator-associated pneumonia
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| mechanically ventilated children admitted to the pediatric intensive care unit (PICU). | – | Other: no needChildren aged between 1 months and 18 years of age • Children admitted to PICU requiring invasive mechanical ventilation (MV) ≥ 48 hours and received any form of sedation or analgesia during ventilation ≥ 48 hours. (e.g., midazolam 4 (loading dose 0.05-0.1 mg/kg IV and maintenance dose 0.03-0.12 mg/kg/hr IV), fentanyl (loading dose 1-2 mcg/kg IV over 10min and maintenance dose 1-4 mcg/kg/hr IV infusion), ketamine (loading dose 0.5-1 mg/kg IV and maintenance dose 0.1-0.5 mg/kg/hr), morphine (loading dose 0.05-0.1 mg/kg IV and maintenance dose 0.05-0.1 mg/kg IV) |
Who may qualify
- Ages
- 0 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children admitted to PICU requiring invasive mechanical ventilation (MV) ≥ 48 hours and received any form of sedation or analgesia during ventilation ≥ 48 hours.
Key inclusion criteria (1 listed)
- Children admitted to PICU requiring invasive mechanical ventilation (MV) ≥ 48 hours and received any form of sedation or analgesia during ventilation ≥ 48 hours.
Key exclusion criteria (1 listed)
- children ventilated after cardiac arrest
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 |
|---|---|---|
| no needno need | Other | mechanically ventilated children admitted to the pediatric intensive care unit (PICU). |
Primary outcome
The Richmond Agitation-Sedation Scale (RASS)
Time frame: 1 year
is a validated 10-point clinical tool used in PICUs to assess patient alertness, agitation, and sedation depth in <20 seconds. In your sedation-outcome study, nurses score RASS every 4-8 hours to classify adequate sedation (target: RASS -2 to 0) vs. under-sedation (>0) or over-sedation (≤-3)
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 15 Sep 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mechanically Ventilated Children Admitted to the Pediatric Intensive Care Unit, run by Yasmine Ahmed Abdelrahman at 1 site in Egypt.
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 1 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 15 Sep 2026. 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 Egypt. 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?
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?
Contact yasmeen Ahmed abdelrhman (01289750281, Yassmin.Abdelrahman@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Richmond Agitation-Sedation Scale (RASS) (time frame: 1 year). 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 15 Sep 2026.