Nebulized Hypertonic Saline for Mechanically Ventilated Children

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by University Hospitals of Cleveland
Sponsor:
Information provided by (Responsible Party):
Steven Shein, University Hospitals of Cleveland
ClinicalTrials.gov Identifier:
NCT01945944
First received: September 12, 2013
Last updated: October 14, 2013
Last verified: October 2013
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Nebulized Hypertonic Saline for Mechanically Ventilated Children

Resource links provided by NLM:


Further study details as provided by University Hospitals of Cleveland:

Primary Outcome Measures:
  • Duration of mechanical ventilation [ Time Frame: typically 4 days - 2 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • atelectasis [ Time Frame: during mechanical ventilation (typically 4 days - 2 weeks) ] [ Designated as safety issue: No ]
    using chest x ray score

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

  • ICU length of stay [ Time Frame: during hospitalization (typically 4 days - 2 weeks) ] [ Designated as safety issue: No ]
  • hospital length of stay [ Time Frame: during hospitalization (typically 4 days - 2 weeks) ] [ Designated as safety issue: No ]
  • serum sodium level [ Time Frame: during hospitalization (typically 4 days - 2 weeks) ] [ Designated as safety issue: Yes ]
  • dynamic compliance [ Time Frame: during mechanical ventilation (typically 4 days - 2 weeks) ] [ Designated as safety issue: No ]
    measured in ml/cm H20/kg using parameters on mechanical ventilator

  • oxygenation [ Time Frame: during mechanical ventilation (typically 4 days - 2 weeks) ] [ Designated as safety issue: Yes ]
    PaO2/FiO2, SaO2/FiO2

  • dead space [ Time Frame: during mechanical ventilation (typically 4 days - 2 weeks) ] [ Designated as safety issue: Yes ]
    in % of tidal volume, using parameters on mechanical ventilator


Estimated Enrollment: 20
Study Start Date: October 2013
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: December 2013 (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)
Experimental: Hypertonic Saline
Hypertonic saline (3%), 3mL every 6hrs for up to 7 days
Drug: Hypertonic saline (3%)

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.

  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT01945944

Locations
United States, Ohio
Rainbow Babies and Children's Hospital (of Univ. Hospitals Case Med. Center) Recruiting
Cleveland, Ohio, United States, 44106
Contact: Steven L Shein, MD    216-368-2329    steven.shein@uhhospitals.org   
Sponsors and Collaborators
University Hospitals of Cleveland
Investigators
Principal Investigator: Steven L Shein, MD University Hospitals of Cleveland
  More Information

Publications:

Responsible Party: Steven Shein, Attending Physician, University Hospitals of Cleveland
ClinicalTrials.gov Identifier: NCT01945944     History of Changes
Other Study ID Numbers: 08-13-11
Study First Received: September 12, 2013
Last Updated: October 14, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University Hospitals of Cleveland:
pediatric
mucolytic
respiratory failure
atelectasis
hypertonic saline

Additional relevant MeSH terms:
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 28, 2014