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Completed

NCT Number: NCT02168387

Efficacy of Percussive Ventilation Therapy (MetaNeb ®) Compared With Mucolytic Agents for Atelectasis in the Mechanically Ventilated Pediatric Patient

The purpose of this study is to evaluate whether a therapy that uses a machine called a continuous high frequency oscillator (CHFO) is more successful at removing mucus than medications that thin out the mucus.

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Key information

Conditions

Atelectasis Lung Diseases Pulmonary Atelectasis Respiratory Tract Diseases

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

Both of these therapies (CHFO and medication) are currently used in the Pediatric Intensive Care Unit and Pediatric Cardiac Intensive Care Unit. This research study is being done because the investigator is trying to learn if the mechanical removal of mucus with CHFO will effectively re-inflate the collapsed area of lung. Specifically, the study team will determine if CHFO can improve lung inflation with the same or improved vital signs (heart rate, blood pressure, and breathing rate), and the same or improved ability to help the lungs move oxygen into the blood.

One of the problems with the medication approach is that while it thins out the mucus, actual removal from the lung requires a strong cough which is difficult for infants and children to produce when they are sedated and on a ventilator (breathing machine).

Thus, the aim of this research study is to test whether children with atelectasis on a ventilator are more likely to improve with mechanical removal of their mucus with the CHFO as compared with medications that thin out the mucus. CHFO and all the medications used in this study are part of the standard of care for atelectesis. However, there is no information on which combination works best and no one agrees that one approach is more effective than another. Usually patients are evaluated for 48 hours after starting treatment, before adding or making any changes.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Informed consent from parent or legal guardian.
  • Age < 18 years and admitted to the PICU or PCICU.
  • Conventionally ventilated.
  • Mucolytics are being initiated by clinical team for treatment of atelectasis.
  • Endotracheal tube ≥ 3.5 mm internal diameter.

Exclusion criteria

  • Receiving chronic mucolytic or continuous high frequency oscillation therapy.
  • Clinically significant pleural effusion.
  • Status post cardiothoracic surgery with open chest.
  • Pneumothorax.
  • Pulmonary hemorrhage.
  • Escalating doses of vasoactive agents (i.e. dopamine or epinephrine).

Treatment and study plan

continuous high frequency oscillator (CHFO)

Device

acetylcysteine

Drug

Dornase Alfa

Drug

Primary outcomes

  1. Improvement of Atelectasis

    Time frame: after 48 hours of therapy

    An atelectasis score (AS), as published by Deakins, et al. 2002, was assigned to each radiograph as follows:

    0 Complete resolution of collapse

    • Partial collapse of 1 segment or lobe
    • Partial collapse of ≥ 2 segments or lobes
    • Complete collapse of 1 segment or lobe
    • Complete collapse of ≥ 2 segments or lobes

    In the event of inter-rater disagreement, the scores were averaged. Improvement was defined as any decrease in AS ≥ 0.5. Worsening was defined as an increase in AS ≥ 0.5 or escalation of respiratory support modality (i.e. high frequency ventilation).

Secondary outcomes

  1. Change in Capnography (Vd/Vt)

    Time frame: baseline and 48 hours

    The deadspace-to-tidal volume (Vd/Vt) ratio is a parameter that is measured in mechanically ventilated patients as a way to assess the severity of gas exchange impairment and to assist in determining whether a patient is ready to be weaned from the ventilator. The change from baseline was measured at 48 hours, with a decreasing ratio indicating improvement.

  2. Change in Quantity and Quality of Suctioned Mucus

    Time frame: baseline and 48 hours

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Jun 20, 2014
Registry last updated
Mar 3, 2015

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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