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Sponsored by: |
National Heart, Lung, and Blood Institute (NHLBI) |
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Information provided by: | National Heart, Lung, and Blood Institute (NHLBI) |
ClinicalTrials.gov Identifier: | NCT00814099 |
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.
Condition | Intervention | Phase |
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Respiratory Insufficiency Respiratory Distress Syndrome, Newborn Lung Diseases |
Behavioral: Team approach to sedation management Behavioral: Usual approach to sedation management |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Sedation Management in Pediatric Patients With Acute Respiratory Failure |
Estimated Enrollment: | 2754 |
Study Start Date: | January 2009 |
Estimated Study Completion Date: | November 2011 |
Estimated Primary Completion Date: | November 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
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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2: Experimental
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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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:
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.
Ages Eligible for Study: | up to 18 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Elizabeth A. Ferguson, RN, BSN | 215-898-2937 | eferguso@nursing.upenn.edu |
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 ( Martha A.Q. Curley, RN, PhD, FAAN ) |
Study ID Numbers: | 611, U01 HL086649, U01 HL086622 |
Study First Received: | December 19, 2008 |
Last Updated: | December 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00814099 |
Health Authority: | United States: Federal Government |
Acute Respiratory Failure Acute Lung Injury |
Respiratory Insufficiency Respiratory Tract Diseases Lung Diseases Respiration Disorders Respiratory Distress Syndrome, Adult |
Respiratory Distress Syndrome, Newborn Infant, Newborn, Diseases Acute respiratory distress syndrome Infant, Premature, Diseases |