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

Overview

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.

Full Title of Study: “Mucolytic Agents and Ventilator-associated Pneumonia in Patients on Invasive Mechanical Ventilation Due to Severe Acute Respiratory Syndrome Coronavirus 2”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: July 29, 2021

Interventions

  • Other: Inhalation of N-acetylcysteine
    • Group 1 will receive N-acetylcysteine inhalation every 12 hours from the beginning of invasive mechanical ventilation.
  • Other: Inhalation of 5% sodium chloride
    • Group 2 will receive inhalation with a 5% sodium chloride solution every 12 hours from the beginning of invasive mechanical ventilation.
  • Other: Inhalation of 8,4% sodium bicarbonate
    • Group 3 will receive inhalation of 8.4% sodium bicarbonate every 12 hours from the beginning of invasive mechanical ventilation.

Arms, Groups and Cohorts

  • Active Comparator: N-acetylcysteine
    • Inhalation of 5 ml-s of N-acetylcysteine every 12 hours.
  • Active Comparator: Hypertonic saline
    • Inhalation of 5 ml-s of 5% sodium chloride every 12 hours.
  • Active Comparator: Bicarbonate
    • Inhalation of 5 ml-s 8.4% sodium bicarbonate every 12 hours.
  • No Intervention: Control group
    • No preventive inhalation.

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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.
  • Mortality
    • Time Frame: Day 28 after ICU admission.
    • Life status (alive or deceased) on day 28 after ICU admission.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Clinical Hospital Center, Split
  • Provider of Information About this Clinical Study
    • Principal Investigator: Nikola Delić, MD, intensive care specialist – Clinical Hospital Center, Split
  • Overall Contact(s)
    • Nikola Delić, MD, +385989000150, nkldelic@gmail.com

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