Clinical trial NCT04755972: Mucolytics in Patients on Invasive Mechanical Ventilation Due to Severe Acute Respiratory Syndrome Coronavirus 2
Official title: Mucolytic Agents and Ventilator-associated Pneumonia in Patients on Invasive Mechanical Ventilation Due to Severe Acute Respiratory Syndrome Coronavirus 2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Corona Virus Infection
Pneumonia, Ventilator-Associated
Keywords: coronavirus disease 2019
Pneumonia, Ventilator-Associated
hypertonic saline
bicarbonate
N-acetylcysteine
Lead sponsor: Clinical Hospital Center, Split
Sponsor class: OTHER
First posted: 2021-02-16
Enrollment: 175
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Difference between 4 arms regarding ventilator-associated pneumonia rate
timeFrame: Through study completion, an average of 6 months.
Secondary outcomes:
measure: Number of ventilator-free days
timeFrame: Day 28 after ICU admission.
measure: Mortality
timeFrame: Day 28 after ICU admission.
Other outcomes:
Locations:
city: Split
country: Croatia
facility: Clinical Hospital Centre Split
Study officials:
References: