Pneumonia Clinical Trial
Official title:
Mechanical Insufflation-Exsufflation Compared With CPAP in Patients Admitted to an Intermediate Care Unit With Pneumonia: a Randomised Controlled Study.
Pneumonia, an infection in the lower airways, is a common cause of hospital contacts and a
leading cause of death from infections worldwide. Pneumonia is treated with antibiotics, and
while waiting for the effect thereof patients may need supportive treatment to help their
lungs work optimally.
When patients suffering from pneumonia have problems breathing, Continuous Positive Airway
Pressure (CPAP) is widely used. CPAP works by forcing air down the patient's airway. In
patients with pneumonia, though CPAP has proven to provide more oxygen to the lungs compared
to a standard oxygen mask, it does not have any effect on the outcome.
Mechanical insufflation-exsufflation (MIE), examined in this study, is given through a
machine connected to a mask. If provides a positive airway pressure like CPAP, but the
inwards pressure is followed immediately by a negative pressure forcing air and mucus up from
the lower airways. MIE is currently used successfully in patients suffering from
neuromuscular diseases. In these patients, MIE has shown to prevent hospital admission,
prolong survival and delay time until need of permanent ventilation. There exists no studies
examining the effect of MIE on patients with pneumonia without neuromuscular disorders.
The investigators therefore wish to study patients with severe pneumonia, admitted to an
intermediate care unit, and compare patients treated with MIE to patients treated with CPAP.
30 patients will be included and randomly selected to receive either CPAP or MIE. They will
be monitored through registration of oxygen need (liters/min) and oxygen levels, respiratory
rate and the daily number of suction due to mucus.
Data from each patient regarding their age, sex, other known diseases, the severity of
pneumonia, chest X-ray findings, antibiotic treatment up to and during the admission, days
admitted, hours admitted to the intermediate care unit, if they are transferred to the
intensive care unit and put on a ventilator, 30-days mortality and re-admittance within 30
days of being discharged, will be registered. To enter the study, the patients have to be 18
years old, able to sign a written consent form, have no current chest tube, no recent
collapsed lung and no chronic lung disease.
The hypothesizes is that patients receiving MIE will be helped with coughing up mucus in the
lower airways, and therefore have less need of oxygen, and that the patients receiving MIE
will have a reduced risk of being transferred to the intensive care unit to receive
ventilator support and spend shorter time in the intermediate care unit compared with the
other group.
Background
Mechanical insufflation-exsufflation (MIE) was invented to help mobilize secretion from the
lower respiratory tract by simulating a cough [1]. It is widely used in patients who have
neuromuscular disease and therefore reduced cough strength, both during hospital admissions,
and in patients' homes. Delivered by a Cough Assistor device through a mask, MIE functions by
delivering a positive inspiratory pressure followed immediately by a negative expiratory
pressure [1].
In patients with neuromuscular disease, MIE prevents hospital admissions, improves survival
rates and delay time to tracheostomy [1]. In this patient group, MIE has proven to be safe
with few adverse effects, and generally well tolerated [1-3].
In patients with neuromuscular disease and an acute respiratory-tract infection, MIE in
combination with non-invasive ventilation (NIV) is superior to NIV alone in removing
secretion from the airways in patients with respiratory tract infections [2]. In a study
among patients with severe chronic obstructive pulmonary disease (COPD) and difficulties
clearing airway secretions after acute respiratory failure, MIE had a significant effect on
both oxygenation and dyspnea [3].
Pneumonia is, with a yearly incidence of 5-11 per 1.000 adult population, a leading cause of
morbidity worldwide [4]. Around 22-42% of adults with community-acquired pneumonia (CAP)
require hospitalization [4]. Globally, pneumonia is the leading cause of death due to
infections, and the mortality among hospitalized patients with pneumonia is 5.7-14% [4,5].
Pneumonia is seen with increased incidence in high risk patient groups such as the elderly,
smokers, patients with immunodeficiencies and co-morbidities [6]. Early initiation of
appropriate antimicrobial therapy is the cornerstone in treatment of pneumonia and has been
shown to shorten the course of disease and lessen the risk of complications and mortality
[7].
In the acute phase of the disease, in addition to effective antimicrobial treatment,
supportive treatment is important to optimize the respiratory care of the patients.
Continuous positive airway pressure (CPAP) delivered through a face mask is widely used as
supportive treatment and improves oxygenation in patients with acute hypoxemic respiratory
failure compared to oxygen delivered by mask [8]. CPAP also improves oxygenation in patients
with pneumonia in a hospital setting compared to oxygen therapy, but the effect quickly
resolves after discontinuation, and CPAP has failed to show effect on endotracheal intubation
rate, hospital mortality and length of intensive care unit stay in patients with acute
respiratory failure [8-10].
There are, to the investigators knowledge, no published studies who evaluate the effect of
MIE on patients with acute respiratory-tract infections without neuromuscular disease.
The aim of this study is to investigate the safety and effect of MIE on patients hospitalized
due to lower respiratory-tract infections and examine their outcome with the current standard
treatment of CPAP.
Hypothesis Patients receiving MIE have better mobilization of secretions from the lower
airways, and thereby faster oxygenation. Patients in the MIE group will have less need of
ventilator support, and have a shorter admission to the intermediate care unit.
Methods
Study design This randomized clinical pilot study is conducted at the intermediate care unit
at the Department of Infectious Diseases, Odense University Hospital, Denmark. The
intermediate care unit consists of 3 beds, all served by a nurse with special training in
intermediate care. Continuous monitoring of blood pressure, pulse, oxygen saturation and
respiratory rate is available. The assessment of the patient and admittance to the
intermediate care unit is determined by the senior infectious disease doctor on call.
Randomization In total, 30 patients will be included and undergo 1:1 randomization to receive
either CPAP or CPAP followed by MIE.
Interventions CPAP will be administered through MR 810 (Fisher & Paykel Healthcare, Auckland,
New Zealand) with standard settings of H2O and an oxygen flow of 15L/min [11]. CPAP is given
by trained physiotherapists or nurses at the intermediate care unit.
MIE will be administered through the NIPPY Clearway (B&D Electromedical, Stratford-Upon-Avon,
Warwickshire, United Kingdom) with standard settings of insufflation 20 cm H2O and
exsufflation 20 cm H2O, with possible individual changes from 10/-10 H2O up to 40/-40 H2O,
and oxygen flow up to 15 l/min [12]. The standard settings will be set to five cycles of 2
seconds insufflation, 3 seconds exsufflation with a three second pause between each cycle.
Every treatment session consists of five rounds of five cycles, in all 25
insufflation/exsufflation, with time between each cycle of 30 seconds, meant used for
suction. The MIE is given by trained physiotherapists or nurses at the intermediate care
unit.
Clinical data The following data will be registered for each patient: age, sex,
comorbidities, the severity of pneumonia using the CURB-65 score [13], chest radiograph
findings, antibiotic treatment up to and during the admission, days of admission, hours
admitted to the semi-intensive unit, transfer to intensive care unit (ICU), intubation and
mechanical ventilation, in-hospital and 30-days mortality and re-admittance within 30 days of
discharge. During the admission in the intermediate care unit, number of CPAP and MIE
treatments, oxygenation and oxygen need (liters/min) every 2 hours for the first 24 hours,
hereafter every 4 hours, respiratory rate every 6 hours for the first 24 hours, hereafter
every day, and the daily number of suction in pharynx or trachea in each patient will be
registered.
Paraclinical data For each patient, microbial growth from blood and sputum cultures will be
registered, as will Polymerase Chain Reaction (PCR) results from sputum samples and relevant
bacterial serology during admission, C-reactive protein (CRP), white blood cell count (WBC)
and urea at time of admission, time of entering the intermediate care unit, time of discharge
from the intermediate care unit and time of discharge from the hospital.
Statistical analysis Fisher's exact test and Wilcoxon rank sum will be used for categorical
and continuous variables, respectively. A p-value of < 0.05 is considered statistically
significant. The statistical analyses will be performed using STATA version 13.0.
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