Nebulized Hypertonic Saline for Mechanically Ventilated Children

University Hospitals (UH)

Status and phase: Completed; Phase 2; Phase 1

Conditions: Respiratory Failure

Treatments: Drug: Placebo (0.9% saline); Drug: Hypertonic saline (3%)

Study type: Interventional

Funder types: Other

Identifiers

NCT01945944

08-13-11

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 18 patients

Sex: All

Ages: Under 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• invasive mechanical ventilation of < 12 hrs duration prior to enrollment
• expected duration of 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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18 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo (0.9% saline), 3mL every 6 hrs for up to 7 days

Treatment:

Drug: Placebo (0.9% saline)

Hypertonic Saline

Experimental group

Description:

Hypertonic saline (3%), 3mL every 6hrs for up to 7 days

Treatment:

Drug: Hypertonic saline (3%)