Sedation Management in Pediatric Patients With Acute Respiratory Failure (The RESTORE Study) (NCT00814099) | Clinical Trial Compass
CompletedNot Applicable
Sedation Management in Pediatric Patients With Acute Respiratory Failure (The RESTORE Study)
United States2,449 participantsStarted 2009-01
Plain-language summary
People with acute respiratory failure usually require the use of an artificial breathing machine, known as a mechanical ventilator. Sedative medications, which help keep people calm and reduce anxiety, are often prescribed for children who are on mechanical ventilators. However, the longer that sedative medications are used, the longer a child may need to remain on mechanical ventilation. This study will evaluate the effectiveness of a team approach to sedation management that aims to reduce the number of days that children with acute respiratory failure require mechanical ventilation.
Who can participate
Age range
2 Weeks – 18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* At least 2 weeks of age (and at least 42 weeks post-menstrual age) and less than 18 years of age
* Intubated and mechanically ventilated for acute lung disease
Exclusion Criteria:
* Cyanotic heart disease with unrepaired or palliated right to left intracardiac shunt
* History of single ventricle at any stage of repair
* Congenital diaphragmatic hernia or paralysis
* Primary pulmonary hypertension
* Critical airway or anatomical obstruction of the lower airway
* Ventilator dependent upon pediatric ICU admission
* Neuromuscular respiratory failure
* Spinal cord injury above the lumbar region
* Pain managed by patient-controlled analgesia or epidural catheter
* Patient transferred from an outside ICU where sedatives had already been administered for more than 24 hours
* Family or medical team has decided not to provide full support
* Enrolled in any other critical care interventional clinical trial concurrently or in the 30 days before study entry
* Known allergy to any of the study medications
* Pregnancy
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Duration of mechanical ventilation
Timeframe: Measured from the time of endotracheal intubation to the end of scheduled sedation therapy, hospital discharge, or Day 28 (whichever comes first)