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Completed

NCT Number: NCT01945944

Nebulized Hypertonic Saline for Mechanically Ventilated Children

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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Key information

Conditions

Respiratory Failure Lung Diseases Pulmonary Atelectasis Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Rainbow Babies and Children's Hospital (of Univ. Hospitals Case Med. Center)

Cleveland, Ohio, 44106, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hypertonic saline (3%)

Drug

3mL of HTS given via nebulizer every 6hrs

Other names: 3% saline

Placebo (0.9% saline)

Drug

3mL of normal saline given via nebulizer every 6hrs

Other names: normal saline

Primary outcomes

  1. Duration of Mechanical Ventilation

    Time frame: typically 4 days - 2 weeks

Secondary outcomes

  1. Atelectasis

    Time frame: during mechanical ventilation (typically 4 days - 2 weeks)

    using chest x ray score. The score measures the amount of lung collapse ("atelectasis") observed on a chest x-ray. For each of the 5 lung lobes, 1 point is given for linear atelectasis, 2 points for sub-segmental atelectasis and 3 points for lobar atelectasis. The range is 0-15 points, with higher scores reflecting more severe lung collapse.

  2. Wheezing

    Time frame: during mechanical ventilation (typically 4 days - 2 weeks)

    as dichotomous outcome (yes/no) following drug administration

  3. ICU Length of Stay

    Time frame: during hospitalization (typically 4 days - 2 weeks)

  4. Hospital Length of Stay

    Time frame: during hospitalization (typically 4 days - 2 weeks)

  5. Change in Serum Sodium From Baseline

    Time frame: during hospitalization (typically 4 days - 2 weeks)

    The baseline sodium was the last level measured prior to study initiation, typically within 24hrs of study initiation. The change in blood sodium level was calculated as the difference between the mean post-enrollment sodium level during ICU care and the sodium level at enrollment.

  6. Dynamic Compliance

    Time frame: during mechanical ventilation (typically 4 days - 2 weeks)

    measured in ml/cm H20/kg using parameters on mechanical ventilator

  7. Oxygenation

    Time frame: during mechanical ventilation (typically 4 days - 2 weeks)

    SaO2/FiO2. This is a measure of how will the lungs are providing oxygen to the body. Higher ratios reflect better lung function.

  8. Dead Space

    Time frame: during mechanical ventilation (typically 4 days - 2 weeks)

    in % of tidal volume, using parameters on mechanical ventilator. Dead space is a measure of how much of the lung is not able to move air into and out of the body. Higher levels of dead space reflect higher levels of lung dysfunction.

Sponsors and collaborators

Lead sponsor

University Hospitals Cleveland Medical Center

Other

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Sep 19, 2013
Registry last updated
Jun 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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