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

Not Applicable

Completed

• Conditions: Pneumonia, Ventilator-Associated; Corona Virus Infection
• Interventions: Other: Inhalation of 8,4% sodium bicarbonate; Other: Inhalation of N-acetylcysteine; Other: Inhalation of 5% sodium chloride

• Registration Number: NCT04755972
• Lead Sponsor: Clinical Hospital Center, Split

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-01
• Study First Submitted: 2021-02-06
• Study First Submitted QC: 2021-02-13
• Study First Posted: 2021-02-16
• Primary Completion: 2021-07-01
• Study Completion: 2021-07-29
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-11
• Last Update Posted: 2022-02-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 175

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bicarbonate	Inhalation of 8,4% sodium bicarbonate	Inhalation of 5 ml-s 8.4% sodium bicarbonate every 12 hours.
N-acetylcysteine	Inhalation of N-acetylcysteine	Inhalation of 5 ml-s of N-acetylcysteine every 12 hours.
Hypertonic saline	Inhalation of 5% sodium chloride	Inhalation of 5 ml-s of 5% sodium chloride every 12 hours.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Clinical Hospital Centre Split; 🇭🇷 Split, Croatia