Sedation Management in Pediatric Patients With Acute Respiratory Failure (The RESTORE Study)

Lung Diseases Clinical Trial

— RESTORE  

Official title:

Sedation Management in Pediatric Patients With Acute Respiratory Failure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00814099
• Other study ID #: 611
• Secondary ID: U01HL086622U01HL
• Status: Completed
• Phase: Phase 3
• First received: December 19, 2008
• Last updated: July 14, 2015
• Start date: January 2009
• Est. completion date: December 2013

Study information

• Verified date: July 2015
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2449
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 18 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lung Diseases
• Pulmonary Valve Insufficiency
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn
• Respiratory Insufficiency

Intervention

Behavioral:
• Team approach to sedation management
The team approach to sedation management includes the following: Team education and consensus on the use of sedatives Team identification of the patient's trajectory of illness and daily prescription of a sedation goal A nurse-implemented goal-directed comfort algorithm that guides moment-to-moment titration of opioids and benzodiazepines Team feedback on sedation management performance
• Usual approach to sedation management
The pediatric ICU will continue its usual approach to sedation management.

Locations

Country	Name	City	State
United States	C. S. Mott Children's Hospital of the University of Michigan	Ann Arbor	Michigan
United States	Johns Hopkins Children's Center	Baltimore	Maryland
United States	University of Maryland Hospital for Children	Baltimore	Maryland
United States	Children's Hospital of Alabama	Birmingham	Alabama
United States	The Children's Hospital at Montefiore	Bronx	New York
United States	Children's Memorial Hospital, Chicago	Chicago	Illinois
United States	Children's Medical Center Dallas	Dallas	Texas
United States	Medical City Children's Hospital	Dallas	Texas
United States	Duke Children's Hospital and Health Center	Durham	North Carolina
United States	Connecticut Children's Medical Center	Hartford	Connecticut
United States	Children's Mercy Hospital, Kansas City	Kansas City	Missouri
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire
United States	Holtz Children's Hospital	Miami	Florida
United States	Monroe Carell, Jr. Children's Hospital at Vanderbilt	Nashville	Tennessee
United States	Yale-New Haven Children's Hospital	New Haven	Connecticut
United States	Cohen Children's Medical Center of New York	New Hyde Park	New York
United States	Advocate Hope Children's Hospital	Oak Lawn	Illinois
United States	Children's Hospital and Research Center at Oakland	Oakland	California
United States	University of Nebraska Medical Center	Omaha	Nebraska
United States	Children's Hospital of Orange County	Orange	California
United States	Florida Hospital for Children	Orlando	Florida
United States	Lucile Salter Packard Children's Hospital at Stanford	Palo Alto	California
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania
United States	Doernbecher Children's Hospital	Portland	Oregon
United States	University of California Davis Medical Center	Sacramento	California
United States	Primary Children's Medical Center	Salt Lake City	Utah
United States	Children's Hospital at University of California San Francisco Medical Center	San Francisco	California
United States	St. Louis Children's Hospital	St. Louis	Missouri
United States	University Medical Center, The University of Arizona	Tucson	Arizona
United States	Nemours/Alfred I. duPont Hospital for Children	Wilmington	Delaware
United States	University of Massachusetts Memorial Children's Medical Center	Worcester	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of mechanical ventilation		Measured from the time of endotracheal intubation to the end of scheduled sedation therapy, hospital discharge, or Day 28 (whichever comes first)	No
Secondary	Time to recovery of acute respiratory failure		Measured from the time of endotracheal intubation to when participants first meet the criteria to be tested for extubation readiness	No
Secondary	Duration of weaning from mechanical ventilation		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)	No
Secondary	Occurrence of adverse events		Measured for the duration of the study	Yes
Secondary	Detection of life-threatening neurological events		Measured for the duration of the study	No
Secondary	Total sedative exposure		Measured for the duration of the study	No
Secondary	Occurrence of iatrogenic withdrawal symptoms		Measured for the duration of the study	No
Secondary	Pediatric ICU and hospital length of stay		Measured for the duration of the study	No
Secondary	Hospital costs		Measured for the duration of the study	No
Secondary	Study implementation costs and cost-effectiveness		Measured for the duration of the study	No
Secondary	In-hospital mortality		Measured for the duration of the study	Yes
Secondary	Post-discharge quality of life and emotional health		Measured 6 months after pediatric ICU discharge	No

External Links

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