Nebulized Hypertonic Saline for Mechanically Ventilated Children

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2014-05-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Respiratory Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo (0.9% saline)

Intervention Type DRUG

3mL of normal saline given via nebulizer every 6hrs

Hypertonic Saline

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

Group Type EXPERIMENTAL

Hypertonic saline (3%)

Intervention Type DRUG

3mL of HTS given via nebulizer every 6hrs

Interventions

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Hypertonic saline (3%)

3mL of HTS given via nebulizer every 6hrs

Intervention Type DRUG

Placebo (0.9% saline)

3mL of normal saline given via nebulizer every 6hrs

Intervention Type DRUG

Other Intervention Names

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3% saline normal saline

Eligibility Criteria

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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

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No