Atelectasis
Conditions
Keywords
Atelectasis
Brief 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.
Interventions
DRUGNormal saline:
Nebulized isotonic saline solution (4 ml of 0.9 % NaCl) twice daily, for a fixed period of 15 min, after a 15 min premedication with nebulized albuterol (2.5 mg diluted in 3 ml of 0.9 % NaCl).
DRUGHypertonic Saline
Nebulized hypertonic saline solution (4 ml of 7 % NaCl) twice daily, for a fixed period of 15 min, after a 15 min premedication with nebulized albuterol (2.5 mg diluted in 3 ml of 0.9 % NaCl).
DRUGDornase alpha
2.5 mg of DNase (Dornase alpha, PULMOZYME® , Genentech, South San Francisco, CA), nebulized twice daily, after a 15 min premedication with nebulized albuterol (2.5 mg diluted in 3 ml of 0.9 % NaCl).
Sponsors
University of Oklahoma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
1. Patient on invasive mechanical ventilation 2. New Onset (\<48 hours) lobar or multilobar lung atelectasis based on CXR
Exclusion criteria
1. Asthma 2. Severe COPD (FEV1\<30%) 3. Pneumothorax or massive pleural effusion, thought to be causing the atelectasis 4. Lobar atelectasis secondary to compressive tumor. 5. Severe hypoxemia (PaO2/FiO2 \< 75) 6. Hemodynamic Instability 7. Cystic fibrosis patients 8. Allergy to DNase 9. Patients on Acetylcysteine 10. Pregnant women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the Chest X-ray Atelectasis Score | Baseline(Day 0) to Day 7 | Each CXR was assigned an atelectasis score.(\*) The absence or presence of contralateral hyperinflation was marked as 0 or 1 point, respectively. The absence or presence of mediastinal shift was scored as 0 or 1, respectively. Atelectasis was scored for each lobe. A partial atelectasis of one lobe was scored as one point, whereas complete atelectasis of a lobe was marked as two points. The distinction between infiltrate and atelectasis as well as the total scoring was done by the interpreting radiologist. These results were summed for each CXR. The score range from 0 to 10 with 0 indicates no atelectasis,higher value indicates progressively more atelectasis. \*Hendriks T, de Hoog M, Lequin MH, Devos AS, and Merkus PJ: DNase and atelectasis in non-cystic fibrosis pediatric patients. Crit Care. 2005;9:R351-R356. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Extubation | 7 days | percentage of patient who were extubated at day 7 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Normal Saline Nebulized isotonic saline solution (4 ml of 0.9 % NaCl) twice daily, for a fixed period of 15 min, after a 15 min premedication with nebulized albuterol (2.5 mg diluted in 3 ml of 0.9 % NaCl).
Normal saline:: Nebulized isotonic saline solution (4 ml of 0.9 % NaCl) twice daily, for a fixed period of 15 min, after a 15 min premedication with nebulized albuterol (2.5 mg diluted in 3 ml of 0.9 % NaCl). | 11 |
| Hypertonic Saline Nebulized hypertonic saline solution (4 ml of 7 % NaCl) twice daily, for a fixed period of 15 min, after a 15 min premedication with nebulized albuterol (2.5 mg diluted in 3 ml of 0.9 % NaCl).
Hypertonic Saline: Nebulized hypertonic saline solution (4 ml of 7 % NaCl) twice daily, for a fixed period of 15 min, after a 15 min premedication with nebulized albuterol (2.5 mg diluted in 3 ml of 0.9 % NaCl). | 11 |
| Dornase Alpha 2.5 mg of DNase (Dornase alpha, PULMOZYME® , Genentech, South San Francisco, CA), nebulized twice daily, after a 15 min premedication with nebulized albuterol (2.5 mg diluted in 3 ml of 0.9 % NaCl).
Dornase alpha: 2.5 mg of DNase (Dornase alpha, PULMOZYME® , Genentech, South San Francisco, CA), nebulized twice daily, after a 15 min premedication with nebulized albuterol (2.5 mg diluted in 3 ml of 0.9 % NaCl). | 11 |
| Total | 33 |
Baseline characteristics
| Characteristic | Normal Saline | Hypertonic Saline | Dornase Alpha | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 0 Participants | 2 Participants | 4 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants | 11 Participants | 9 Participants | 29 Participants |
| Age, Continuous | 45 years STANDARD_DEVIATION 15 | 48 years STANDARD_DEVIATION 15 | 49 years STANDARD_DEVIATION 18 | 47 years STANDARD_DEVIATION 16 |
| Region of Enrollment United States | 11 participants | 11 participants | 11 participants | 33 participants |
| Sex: Female, Male Female | 3 Participants | 4 Participants | 4 Participants | 11 Participants |
| Sex: Female, Male Male | 8 Participants | 7 Participants | 7 Participants | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 11 | 0 / 11 | 0 / 11 |
| serious Total, serious adverse events | 0 / 11 | 0 / 11 | 0 / 11 |
Outcome results
Primary
Change in the Chest X-ray Atelectasis Score
Each CXR was assigned an atelectasis score.(\*) The absence or presence of contralateral hyperinflation was marked as 0 or 1 point, respectively. The absence or presence of mediastinal shift was scored as 0 or 1, respectively. Atelectasis was scored for each lobe. A partial atelectasis of one lobe was scored as one point, whereas complete atelectasis of a lobe was marked as two points. The distinction between infiltrate and atelectasis as well as the total scoring was done by the interpreting radiologist. These results were summed for each CXR. The score range from 0 to 10 with 0 indicates no atelectasis,higher value indicates progressively more atelectasis. \*Hendriks T, de Hoog M, Lequin MH, Devos AS, and Merkus PJ: DNase and atelectasis in non-cystic fibrosis pediatric patients. Crit Care. 2005;9:R351-R356.
Time frame: Baseline(Day 0) to Day 7
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Normal Saline | Change in the Chest X-ray Atelectasis Score | -1 units on a scale | Standard Deviation 2.12 |
| Hypertonic Saline | Change in the Chest X-ray Atelectasis Score | -0.86 units on a scale | Standard Deviation 1.34 |
| Dornase Alpha | Change in the Chest X-ray Atelectasis Score | -2.18 units on a scale | Standard Deviation 1.33 |
Secondary
Rate of Extubation
percentage of patient who were extubated at day 7
Time frame: 7 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Normal Saline | Rate of Extubation | 6 Participants |
| Hypertonic Saline | Rate of Extubation | 5 Participants |
| Dornase Alpha | Rate of Extubation | 7 Participants |