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Nebulized Hypertonic Saline for Mechanically Ventilated Children

This study has been completed.
Information provided by (Responsible Party):
Steven Shein, University Hospital Case Medical Center Identifier:
First received: September 12, 2013
Last updated: May 19, 2016
Last verified: May 2016
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.

Condition Intervention Phase
Respiratory Failure
Drug: Hypertonic saline (3%)
Drug: Placebo (0.9% saline)
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Nebulized Hypertonic Saline for Mechanically Ventilated Children

Further study details as provided by University Hospitals Cleveland Medical Center:

Primary Outcome Measures:
  • Duration of Mechanical Ventilation [ Time Frame: typically 4 days - 2 weeks ]

Secondary Outcome Measures:
  • 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.

  • Wheezing [ Time Frame: during mechanical ventilation (typically 4 days - 2 weeks) ]
    as dichotomous outcome (yes/no) following drug administration

  • ICU Length of Stay [ Time Frame: during hospitalization (typically 4 days - 2 weeks) ]
  • Hospital Length of Stay [ Time Frame: during hospitalization (typically 4 days - 2 weeks) ]
  • 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.

  • Dynamic Compliance [ Time Frame: during mechanical ventilation (typically 4 days - 2 weeks) ]
    measured in ml/cm H20/kg using parameters on mechanical ventilator

  • 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.

  • 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.

Enrollment: 18
Study Start Date: October 2013
Study Completion Date: May 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Placebo (0.9% saline), 3mL every 6 hrs for up to 7 days
Drug: Placebo (0.9% saline)
3mL of normal saline given via nebulizer every 6hrs
Other Name: normal saline
Experimental: Hypertonic Saline
Hypertonic saline (3%), 3mL every 6hrs for up to 7 days
Drug: Hypertonic saline (3%)
3mL of HTS given via nebulizer every 6hrs
Other Name: 3% saline

Detailed 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.


Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01945944

United States, Ohio
Rainbow Babies and Children's Hospital (of Univ. Hospitals Case Med. Center)
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
University Hospitals Cleveland Medical Center
Principal Investigator: Steven L Shein, MD University Hospitals Cleveland Medical Center
  More Information


Responsible Party: Steven Shein, Attending Physician, University Hospital Case Medical Center Identifier: NCT01945944     History of Changes
Other Study ID Numbers: 08-13-11
Study First Received: September 12, 2013
Results First Received: July 27, 2015
Last Updated: May 19, 2016
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by University Hospitals Cleveland Medical Center:
respiratory failure
hypertonic saline

Additional relevant MeSH terms:
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases processed this record on April 26, 2017