N/A
N=33
Dornase Alpha Versus Hypertonic Saline for Lung Atelectasis in Non-Cystic Fibrosis Patients
Atelectasis
Bottom Line
View on ClinicalTrials.gov: NCT00671723 ↗Enrolled (actual)
33
Serious AEs
0.0%
Results posted
Jul 2017
Primary outcome: Primary: Change in the Chest X-ray Atelectasis Score — -1; -0.86; -2.18 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Normal saline: (Drug); Hypertonic Saline (Drug); Dornase alpha (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Oklahoma
- Primary completion
- Jul 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in the Chest X-ray Atelectasis Score |
-1; -0.86; -2.18 | — |
| SECONDARY Rate of Extubation |
6; 5; 7 | — |
Summary
Despite the lack of trials proving the efficacy of DNase in non cystic fibrosis patients, it is currently heavily used in this population. In fact, per evidence of barcode scanning via Meditech computer system at OU Medical Center 93% of the DNase prescribed in 2005 was for non Cystic fibrosis patients with an estimated yearly cost of $341,968.15.In vitro studies showed that the effect of Dnase was minimal on sputum viscosity when compared to Hypertonic saline . Furthermore recent studies on hypertonic saline in cystic fibrosis patients showed that it is an inexpensive and safe therapy when preceded by a bronchodilator in patients with cystic fibrosis.
We hereby propose a prospective randomized trial to compare the efficacy of hypertonic saline, DNase, vs. normal saline in the treatment of atelectasis in non cystic fibrosis, mechanically ventilated patient.
Eligibility Criteria
Inclusion Criteria
- Patient on invasive mechanical ventilation
- New Onset (<48 hours) lobar or multilobar lung atelectasis based on CXR
Exclusion Criteria
- Asthma
- Severe COPD (FEV1<30%)
- Pneumothorax or massive pleural effusion, thought to be causing the atelectasis
- Lobar atelectasis secondary to compressive tumor.
- Severe hypoxemia (PaO2/FiO2 < 75)
- Hemodynamic Instability
- Cystic fibrosis patients
- Allergy to DNase
- Patients on Acetylcysteine
- Pregnant women
Data sourced from ClinicalTrials.gov (NCT00671723). 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.