Nebulized Hypertonic Saline for Mechanically Ventilated Children

May 19, 2016 updated by: Steven Shein, University Hospitals Cleveland Medical Center
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Rainbow Babies and Children's Hospital (of Univ. Hospitals Case Med. Center)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • 3% saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Duration of Mechanical Ventilation
Time Frame: typically 4 days - 2 weeks
typically 4 days - 2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
during mechanical ventilation (typically 4 days - 2 weeks)
Wheezing
Time Frame: during mechanical ventilation (typically 4 days - 2 weeks)
as dichotomous outcome (yes/no) following drug administration
during mechanical ventilation (typically 4 days - 2 weeks)
ICU Length of Stay
Time Frame: during hospitalization (typically 4 days - 2 weeks)
during hospitalization (typically 4 days - 2 weeks)
Hospital Length of Stay
Time Frame: during hospitalization (typically 4 days - 2 weeks)
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.
during hospitalization (typically 4 days - 2 weeks)
Dynamic Compliance
Time Frame: during mechanical ventilation (typically 4 days - 2 weeks)
measured in ml/cm H20/kg using parameters on mechanical ventilator
during mechanical ventilation (typically 4 days - 2 weeks)
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.
during mechanical ventilation (typically 4 days - 2 weeks)
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.
during mechanical ventilation (typically 4 days - 2 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospitals Cleveland Medical Center

Investigators

  • Principal Investigator: Steven L Shein, MD, University Hospitals Cleveland Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Actual)

April 1, 2014

Study Completion (Actual)

May 1, 2014

Study Registration Dates

First Submitted

September 12, 2013

First Submitted That Met QC Criteria

September 16, 2013

First Posted (Estimate)

September 19, 2013

Study Record Updates

Last Update Posted (Estimate)

June 28, 2016

Last Update Submitted That Met QC Criteria

May 19, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 08-13-11

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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