Nebulized Hypertonic Saline for Mechanically Ventilated Children
|Respiratory Failure||Drug: Hypertonic saline (3%) Drug: Placebo (0.9% saline)||Phase 1 Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Nebulized Hypertonic Saline for Mechanically Ventilated Children|
- Duration of Mechanical Ventilation [ Time Frame: typically 4 days - 2 weeks ]
- Atelectasis [ Time Frame: during mechanical ventilation (typically 4 days - 2 weeks) ]using chest x ray score. The score measures the amount of lung collapse ("atelectasis") observed on a chest x-ray. For each of the 5 lung lobes, 1 point is given for linear atelectasis, 2 points for sub-segmental atelectasis and 3 points for lobar atelectasis. The range is 0-15 points, with higher scores reflecting more severe lung collapse.
- Wheezing [ Time Frame: during mechanical ventilation (typically 4 days - 2 weeks) ]as dichotomous outcome (yes/no) following drug administration
- ICU Length of Stay [ Time Frame: during hospitalization (typically 4 days - 2 weeks) ]
- Hospital Length of Stay [ Time Frame: during hospitalization (typically 4 days - 2 weeks) ]
- Change in Serum Sodium From Baseline [ Time Frame: during hospitalization (typically 4 days - 2 weeks) ]The baseline sodium was the last level measured prior to study initiation, typically within 24hrs of study initiation. The change in blood sodium level was calculated as the difference between the mean post-enrollment sodium level during ICU care and the sodium level at enrollment.
- Dynamic Compliance [ Time Frame: during mechanical ventilation (typically 4 days - 2 weeks) ]measured in ml/cm H20/kg using parameters on mechanical ventilator
- Oxygenation [ Time Frame: during mechanical ventilation (typically 4 days - 2 weeks) ]SaO2/FiO2. This is a measure of how will the lungs are providing oxygen to the body. Higher ratios reflect better lung function.
- Dead Space [ Time Frame: during mechanical ventilation (typically 4 days - 2 weeks) ]in % of tidal volume, using parameters on mechanical ventilator. Dead space is a measure of how much of the lung is not able to move air into and out of the body. Higher levels of dead space reflect higher levels of lung dysfunction.
|Study Start Date:||October 2013|
|Study Completion Date:||May 2014|
|Primary Completion Date:||April 2014 (Final data collection date for primary outcome measure)|
Placebo Comparator: Placebo
Placebo (0.9% saline), 3mL every 6 hrs for up to 7 days
Drug: Placebo (0.9% saline)
3mL of normal saline given via nebulizer every 6hrs
Other Name: normal saline
Experimental: Hypertonic Saline
Hypertonic saline (3%), 3mL every 6hrs for up to 7 days
Drug: Hypertonic saline (3%)
3mL of HTS given via nebulizer every 6hrs
Other Name: 3% saline
Recent pediatric data shows that less than 80% of children mechanically ventilated for ≥ 96 hours survived to PICU discharge, while 100% of children mechanically ventilated for < 96 hours survived to PICU discharge. Interventions that decrease duration of mechanical ventilation may improve outcome by limiting ventilator-induced lung injury, sedative medication usage and ventilator-associated pneumonia. Obstructive airway secretions may prolong mechanical ventilation by causing atelectasis and endotracheal tube obstruction, with resultant cardio-respiratory instability. Nebulized hypertonic saline (HTS) is used to decrease mucus viscosity and increase mucociliary clearance in patients with diseases such as cystic fibrosis and bronchiolitis, and has been used to enhance airway clearance in mechanically ventilated children. Administering nebulized HTS to mechanically ventilated children may facilitate airway clearance and shorten mechanical ventilation.
In a randomized study of children < 2 years old following cardiac surgery, patients given dornase, another mucolytic agent, had a significantly decreased duration of mechanical ventilation versus those given saline placebo (52 hrs vs. 82 hrs). HTS may be even more effective, as mechanically ventilated newborns with persistent atelectasis had more improvement in radiographic findings and oxygen saturation when randomized to receive hypertonic saline compared to those randomized to receive dornase. This may be because dornase may only be effective in patients with leukocytes or bacterial present in tracheal aspirates, while HTS may be effective in all ventilated patients. Further study of the impact of prophylactic mucolytic therapy on the duration of mechanical ventilation in children is warranted.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01945944
|United States, Ohio|
|Rainbow Babies and Children's Hospital (of Univ. Hospitals Case Med. Center)|
|Cleveland, Ohio, United States, 44106|
|Principal Investigator:||Steven L Shein, MD||University Hospitals Cleveland Medical Center|