Mucolytics in Patients on Invasive Mechanical Ventilation Due to Severe Acute Respiratory Syndrome Coronavirus 2
NCT ID: NCT04755972
Last Updated: 2022-02-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
175 participants
INTERVENTIONAL
2020-10-01
2021-07-29
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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N-acetylcysteine
Inhalation of 5 ml-s of N-acetylcysteine every 12 hours.
Inhalation of N-acetylcysteine
Group 1 will receive N-acetylcysteine inhalation every 12 hours from the beginning of invasive mechanical ventilation.
Hypertonic saline
Inhalation of 5 ml-s of 5% sodium chloride every 12 hours.
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.
Bicarbonate
Inhalation of 5 ml-s 8.4% sodium bicarbonate every 12 hours.
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.
Control group
No preventive inhalation.
No interventions assigned to this group
Interventions
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Inhalation of N-acetylcysteine
Group 1 will receive N-acetylcysteine inhalation every 12 hours from the beginning of invasive mechanical ventilation.
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.
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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Clinical Hospital Center, Split
OTHER
Responsible Party
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Nikola Delić
MD, intensive care specialist
Locations
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Clinical Hospital Centre Split
Split, , Croatia
Countries
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Other Identifiers
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2181-147-01/06/M.S.-20-02
Identifier Type: -
Identifier Source: org_study_id
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