Phase 2
N=18
Nebulized Hypertonic Saline for Mechanically Ventilated Children
Respiratory Failure
Bottom Line
View on ClinicalTrials.gov: NCT01945944 ↗Enrolled (actual)
18
Serious AEs
11.1%
Results posted
Jun 2016
Primary outcome: Primary: Duration of Mechanical Ventilation — 129.5; 208.1 hours
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Hypertonic saline (3%) (Drug); Placebo (0.9% saline) (Drug)
- Age
- Pediatric, Adult
- Sex
- All
- Sponsor
- University Hospitals Cleveland Medical Center
- Primary completion
- Apr 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Duration of Mechanical Ventilation |
129.5; 208.1 | — |
| SECONDARY Atelectasis |
4.67; 4 | — |
| SECONDARY Wheezing |
3; 1 | — |
| SECONDARY ICU Length of Stay |
8; 12 | — |
| SECONDARY Hospital Length of Stay |
15; 17 | — |
| SECONDARY Change in Serum Sodium From Baseline |
1; -1.5 | — |
| SECONDARY Dynamic Compliance |
6.52; 4.47 | — |
| SECONDARY Oxygenation |
239; 188 | — |
| SECONDARY Dead Space |
29; 37 | — |
Summary
Children who need to be on a ventilator often have thick secretions/mucus in their lungs. These secretions can obstruct the breathing tube and their windpipe, which can worsen lung function and prolong the need for the ventilator. Hypertonic saline is a medicine that is used to thin out secretions in patients with cystic fibrosis (and other conditions). We hypothesize that having children on a ventilator inhale this medication will shorten the amount of time that they need to be on the ventilator.
Eligibility Criteria
Inclusion Criteria
- invasive mechanical ventilation of 48hrs from enrollment
- age < 18yo
Exclusion Criteria
- inclusion in another clinical study
- cystic fibrosis
- status asthmaticus
- pulmonary hemorrhage/contusion
- home O2 use
- home non-invasive positive pressure (CPAP/BiPAP) ventilation use
- pre-existing tracheostomy
- prescription of mucolytic medication by primary clinical team
- allergy to inhaled saline/hypertonic saline or albuterol
Data sourced from ClinicalTrials.gov (NCT01945944). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.