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OpenTrials
Completed

NCT Number: NCT04755972

Mucolytics in Patients on Invasive Mechanical Ventilation Due to Severe Acute Respiratory Syndrome Coronavirus 2

It is planned to include patients over 18 years of age of both sexes, admitted to the Intensive Care Unit of Clinical Hospital Centre Split for respiratory insufficiency caused by severe acute respiratory syndrome coronavirus 2 in need of invasive mechanical ventilation.

The patients will be divided into four groups. Group 1 will receive N-acetylcysteine inhalation, Group 2 will receive inhalation with a 5% sodium chloride solution, and Group 3 will receive inhalation of 8.4% sodium bicarbonate, group 4 is a control group and will not routinely receive inhaled mucolytics preventively.

All inhalations will be given twice a day 12 hours apart. The first inhalation will be included within 12 hours of the patient being enrolled in the Intensive Care Unit. Patients will be randomized according to the type of inhalation they will receive, randomization will be done by all researchers through the random.org website, and the inhalation will be given by a nurse according to the agreed protocol.

RESEARCH GOALS

The aim of this study is to determine whether there is a difference in the frequency and duration of ventilator-associated pneumonia (VAP) and whether there is a difference in the number of days spent on mechanical ventilation and in mortality in these four groups of patients.

Hypothesis

Coronavirus disease 2019 patients on invasive mechanical ventilation and preventive sodium bicarbonate inhalation will have a lower incidence of ventilator-associated pneumonia and fewer days spent on invasive mechanical ventilation than patients inhaled with N-acetylcysteine, 5% saline, or patients without preventive inhalation.

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Key information

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients over 18 years of age with coronavirus pneumonia who need invasive mechanical ventilation.

Exclusion criteria

  • Patients with polytrauma,
  • pregnant women,
  • severe hemodynamic instability,
  • patients with pulmonary edema,
  • less than 3 days spent in the ICU,
  • patients who have microbiologically proven bacterial infection on arrival.

Treatment and study plan

Inhalation of N-acetylcysteine

Other

Group 1 will receive N-acetylcysteine inhalation every 12 hours from the beginning of invasive mechanical ventilation.

Inhalation of 5% sodium chloride

Other

Group 2 will receive inhalation with a 5% sodium chloride solution every 12 hours from the beginning of invasive mechanical ventilation.

Inhalation of 8,4% sodium bicarbonate

Other

Group 3 will receive inhalation of 8.4% sodium bicarbonate every 12 hours from the beginning of invasive mechanical ventilation.

Primary outcomes

  1. Difference between 4 arms regarding ventilator-associated pneumonia rate

    Time frame: Through study completion, an average of 6 months.

    Patients will be monitored for ventilator-associated pneumonia according to clinical criteria with a new or progressive pulmonary infiltrate on imaging plus supportive clinical findings of infection (eg, fever, secretions, leukocytosis). The diagnosis is confirmed when lower respiratory tract sampling identifies a pathogen.

Secondary outcomes

  1. Number of ventilator-free days

    Time frame: Day 28 after ICU admission.

    Number of days from day 1 after ICU admission and start of mechanical ventilation on which a patient breathes without assistance of the ventilator if the period of unassisted breathing lasted at least 24 consecutive hours.

  2. Mortality

    Time frame: Day 28 after ICU admission.

    Life status (alive or deceased) on day 28 after ICU admission.

Sponsors and collaborators

Lead sponsor

Clinical Hospital Center, Split

Other

Registry information

Official study title

Mucolytic Agents and Ventilator-associated Pneumonia in Patients on Invasive Mechanical Ventilation Due to Severe Acute Respiratory Syndrome Coronavirus 2

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Feb 16, 2021
Registry last updated
Feb 14, 2022

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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