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

Corona Virus Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04755972
• Other study ID #: 2181-147-01/06/M.S.-20-02
• Status: Completed
• Phase: N/A
• Start date: October 1, 2020
• Est. completion date: July 29, 2021

Study information

• Verified date: February 2022
• Source: Clinical Hospital Center, Split
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 175
• Est. completion date: July 29, 2021
• Est. primary completion date: July 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Corona Virus Infection
• Coronavirus Infections
• COVID-19
• Pneumonia
• Pneumonia, Ventilator-Associated
• Severe Acute Respiratory Syndrome

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Croatia	Clinical Hospital Centre Split	Split

Sponsors (1)

Lead Sponsor	Collaborator
Clinical Hospital Center, Split

Country where clinical trial is conducted

Croatia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference between 4 arms regarding ventilator-associated pneumonia rate	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.	Through study completion, an average of 6 months.
Secondary	Number of ventilator-free days	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.	Day 28 after ICU admission.
Secondary	Mortality	Life status (alive or deceased) on day 28 after ICU admission.	Day 28 after ICU admission.