NCT03714321: CoughAssist

Mechanical Insufflation-Exsufflation Compared With CPAP in Patients Admitted to an Intermediate Care Unit With Pneumonia

Completed NA Last updated 22 October 2018

What this trial tests

NA trial testing Mechanical insufflation-exsufflation (MIE) in Pneumonia in 30 participants. Completed in 9 October 2015.

Timeline

1 January 2014

Primary endpoint
9 October 2015

9 October 2015

Quick facts

Lead sponsor	Odense University Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	supportive care
Enrollment	30
Start date	1 January 2014
Primary completion	9 October 2015
Estimated completion	9 October 2015

Drugs / interventions tested

• Mechanical insufflation-exsufflation (MIE)

Conditions studied

• Pneumonia — all drugs for Pneumonia →

Sponsor

Odense University Hospital

Who can join

18 and older, any sex, with Pneumonia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.