Sedation Management in Pediatric Patients With Acute Respiratory Failure (The RESTORE Study) (RESTORE)
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| ClinicalTrials.gov Identifier: NCT00814099 |
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Recruitment Status :
Completed
First Posted : December 23, 2008
Last Update Posted : July 15, 2015
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Respiratory Insufficiency Respiratory Distress Syndrome, Newborn Lung Diseases | Behavioral: Team approach to sedation management Behavioral: Usual approach to sedation management | Phase 3 |
People who are hospitalized for acute respiratory failure are typically supported on mechanical ventilation, which delivers oxygen and a continuous level of pressure to the damaged lungs. Over 90% of infants and children supported on mechanical ventilation receive some form of sedation medication, which helps keep them safe, calm, and comfortable. Unfortunately, the use of sedation medications may prolong the duration of mechanical ventilation, which can lead to an increased risk for pneumonia and other complications.
Recent studies among adults in intensive care units (ICUs) have shown that when doctors and nurses work together as a team to manage the use of sedation medication, patients are taken off mechanical ventilation sooner and with fewer side effects. This team strategy includes the following:
- Training and discussion between doctors and nurses regarding which sedative medications should be used
- Having doctors and nurses jointly identify the patient's progress and a daily sedation medication goal for the patient
- Having nurses use a decision-making tool to help guide changes in a patient's sedative medication dose
- Keeping track of patient care, which allows doctors and nurses to evaluate the effectiveness of how they manage each patient's sedative medication use
This study will examine the use of the sedation management strategy for infants and children in pediatric ICUs who have acute respiratory failure and require mechanical ventilation. The purpose of the study is to evaluate whether this team approach to sedation medication management is more effective than the usual approach at reducing the amount of time children remain on mechanical ventilators. Study researchers will also examine the cost-effectiveness of this approach and associated quality of life factors.
All participants will be enrolled within 24 hours of starting mechanical ventilation and will be monitored until they receive their last dose of sedative medication, hospital discharge, or Day 28 (whichever comes first). During a 3-month baseline period, all participating pediatric ICUs will provide their usual sedation management, and study researchers will review participants' medical records on a daily basis. Each pediatric ICU will then be randomly assigned to either the control group or the team approach group. Pediatric ICUs in the control group will continue to provide usual care for sedation management. Pediatric ICUs in the team approach group will implement the team approach sedation management guidelines. For both groups, pain and sedation levels will be monitored daily, and study researchers will review participants' medical records on a daily basis, too. Six months after hospital discharge, half of the participants and their parents will complete a follow-up survey and take part in a telephone interview to assess quality of life, psychological factors, and health-related resource use.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 2449 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Sedation Management in Pediatric Patients With Acute Respiratory Failure |
| Study Start Date : | January 2009 |
| Actual Primary Completion Date : | December 2013 |
| Actual Study Completion Date : | December 2013 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: 1
Participants will receive care at a pediatric ICU that is continuing the usual approach to sedation management.
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Behavioral: Usual approach to sedation management
The pediatric ICU will continue its usual approach to sedation management. |
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Experimental: 2
Participants will receive care at a pediatric ICU that is implementing the team approach to sedation management.
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Behavioral: Team approach to sedation management
The team approach to sedation management includes the following:
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- Duration of mechanical ventilation [ Time Frame: Measured from the time of endotracheal intubation to the end of scheduled sedation therapy, hospital discharge, or Day 28 (whichever comes first) ]
- Time to recovery of acute respiratory failure [ Time Frame: Measured from the time of endotracheal intubation to when participants first meet the criteria to be tested for extubation readiness ]
- Duration of weaning from mechanical ventilation [ Time Frame: Measured from the time participants meet the criteria to be tested for extubation readiness until the time of the first successful extubation (defined as extubation for more than 24 hours) ]
- Occurrence of adverse events [ Time Frame: Measured for the duration of the study ]
- Detection of life-threatening neurological events [ Time Frame: Measured for the duration of the study ]
- Total sedative exposure [ Time Frame: Measured for the duration of the study ]
- Occurrence of iatrogenic withdrawal symptoms [ Time Frame: Measured for the duration of the study ]
- Pediatric ICU and hospital length of stay [ Time Frame: Measured for the duration of the study ]
- Hospital costs [ Time Frame: Measured for the duration of the study ]
- Study implementation costs and cost-effectiveness [ Time Frame: Measured for the duration of the study ]
- In-hospital mortality [ Time Frame: Measured for the duration of the study ]
- Post-discharge quality of life and emotional health [ Time Frame: Measured 6 months after pediatric ICU discharge ]
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| Ages Eligible for Study: | 2 Weeks to 18 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00814099
Show 31 study locations
| Principal Investigator: | Martha A.Q. Curley, RN, PhD | University of Pennsylvania | |
| Study Director: | David Wypij, PhD | Director, Statistics and Data Coordinating Center; Children's Hospital Boston |
| Responsible Party: | University of Pennsylvania |
| ClinicalTrials.gov Identifier: | NCT00814099 |
| Other Study ID Numbers: |
611 U01HL086622 ( U.S. NIH Grant/Contract ) U01HL086649 ( U.S. NIH Grant/Contract ) |
| First Posted: | December 23, 2008 Key Record Dates |
| Last Update Posted: | July 15, 2015 |
| Last Verified: | July 2015 |
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Acute Respiratory Failure Acute Lung Injury |
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Lung Diseases Respiratory Distress Syndrome Respiratory Distress Syndrome, Newborn Respiratory Insufficiency |
Respiratory Tract Diseases Respiration Disorders Infant, Premature, Diseases Infant, Newborn, Diseases |