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

Clinical Hospital Center, Split

Status: Completed

Conditions: Pneumonia, Ventilator-Associated; Corona Virus Infection

Treatments: Other: Inhalation of 5% sodium chloride; Other: Inhalation of 8,4% sodium bicarbonate; Other: Inhalation of N-acetylcysteine

Study type: Interventional

Funder types: Other

Identifiers

NCT04755972

2181-147-01/06/M.S.-20-02

Details and patient eligibility

About

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.

Enrollment: 175 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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175 participants in 4 patient groups

N-acetylcysteine

Active Comparator group

Description:

Inhalation of 5 ml-s of N-acetylcysteine every 12 hours.

Treatment:

Other: Inhalation of N-acetylcysteine

Hypertonic saline

Active Comparator group

Description:

Inhalation of 5 ml-s of 5% sodium chloride every 12 hours.

Treatment:

Other: Inhalation of 5% sodium chloride

Bicarbonate

Active Comparator group

Description:

Inhalation of 5 ml-s 8.4% sodium bicarbonate every 12 hours.

Treatment:

Other: Inhalation of 8,4% sodium bicarbonate

Control group

No Intervention group

Description:

No preventive inhalation.