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

Sponsor

Clinical Hospital Center, Split (Other)

Overall Status

Completed

CT.gov ID

NCT04755972

Collaborator

(none)

175

Enrollment

Location

Arms

9.9

Actual Duration (Months)

17.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Corona Virus Infection Pneumonia, Ventilator-Associated	Other: Inhalation of N-acetylcysteine Other: Inhalation of 5% sodium chloride Other: Inhalation of 8,4% sodium bicarbonate	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

175 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Oct 1, 2020

Actual Primary Completion Date :

Jul 1, 2021

Actual Study Completion Date :

Jul 29, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: N-acetylcysteine Inhalation of 5 ml-s of N-acetylcysteine every 12 hours.	Other: Inhalation of N-acetylcysteine Group 1 will receive N-acetylcysteine inhalation every 12 hours from the beginning of invasive mechanical ventilation.
Active Comparator: Hypertonic saline Inhalation of 5 ml-s of 5% sodium chloride every 12 hours.	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.
Active Comparator: Bicarbonate Inhalation of 5 ml-s 8.4% sodium bicarbonate every 12 hours.	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.
No Intervention: Control group No preventive inhalation.

Outcome Measures

Primary Outcome Measures

Difference between 4 arms regarding ventilator-associated pneumonia rate [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 Outcome Measures

Number of ventilator-free days [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 [Day 28 after ICU admission.]
Life status (alive or deceased) on day 28 after ICU admission.