Pneumonia Clinical Trial
— CoughAssistOfficial title:
Mechanical Insufflation-Exsufflation Compared With CPAP in Patients Admitted to an Intermediate Care Unit With Pneumonia: a Randomised Controlled Study.
Verified date | October 2018 |
Source | Odense University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 30 |
Est. completion date | October 9, 2015 |
Est. primary completion date | October 9, 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Community acquired or nosocomial pneumonia, diagnosed by new infiltrate on an x-ray chest and symptoms and/or objective findings acute lower airway infection - 18 years or older - able to participate in CPAP treatment 10 cm H2O for 5 minutes - able to provide written consent Exclusion Criteria: - pneumothorax less than 4 weeks prior to admission - current pleural tube |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Odense University Hospital |
Blasi F, Garau J, Medina J, Ávila M, McBride K, Ostermann H; REACH study group. Current management of patients hospitalized with community-acquired pneumonia across Europe: outcomes from REACH. Respir Res. 2013 Apr 15;14:44. doi: 10.1186/1465-9921-14-44. — View Citation
Brambilla AM, Aliberti S, Prina E, Nicoli F, Del Forno M, Nava S, Ferrari G, Corradi F, Pelosi P, Bignamini A, Tarsia P, Cosentini R. Helmet CPAP vs. oxygen therapy in severe hypoxemic respiratory failure due to pneumonia. Intensive Care Med. 2014 Jul;40( — View Citation
Chatwin M, Simonds AK. The addition of mechanical insufflation/exsufflation shortens airway-clearance sessions in neuromuscular patients with chest infection. Respir Care. 2009 Nov;54(11):1473-9. — View Citation
Cosentini R, Brambilla AM, Aliberti S, Bignamini A, Nava S, Maffei A, Martinotti R, Tarsia P, Monzani V, Pelosi P. Helmet continuous positive airway pressure vs oxygen therapy to improve oxygenation in community-acquired pneumonia: a randomized, controlle — View Citation
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Homnick DN. Mechanical insufflation-exsufflation for airway mucus clearance. Respir Care. 2007 Oct;52(10):1296-305; discussion 1306-7. Review. Erratum in: Respir Care. 2011 Jun;56(6):888. — View Citation
Lim WS, Baudouin SV, George RC, Hill AT, Jamieson C, Le Jeune I, Macfarlane JT, Read RC, Roberts HJ, Levy ML, Wani M, Woodhead MA; Pneumonia Guidelines Committee of the BTS Standards of Care Committee. BTS guidelines for the management of community acquir — View Citation
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MR810 technical manual. file:///C:/Users/lege4/Downloads/9e551a10-ef64-4514-a1bf-ce17cf08451e.pdf Date last accessed: July 12th 2017.
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Welte T. Risk factors and severity scores in hospitalized patients with community-acquired pneumonia: prediction of severity and mortality. Eur J Clin Microbiol Infect Dis. 2012 Jan;31(1):33-47. doi: 10.1007/s10096-011-1272-4. Epub 2011 May 1. Review. — View Citation
Winck JC, Gonçalves MR, Lourenço C, Viana P, Almeida J, Bach JR. Effects of mechanical insufflation-exsufflation on respiratory parameters for patients with chronic airway secretion encumbrance. Chest. 2004 Sep;126(3):774-80. — View Citation
* Note: There are 13 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Admission time in intermediate care unit | Time (in hours) of each patient spent admitted to the intermediate care unit | Admission to intermediate care unit (expected approx. 3-5 days) | |
Primary | Need of mechanical ventilation | For each patient; any need of mechanical ventilation (yes/no) during the entire hospital admission in which the patient is included in the study. | From admission to discharge/death, in the department responsible for the study, the mean duration of admittance is 7 days. Need of ventilation will be registered by investigator through review of patient chart after discharge from hospital. | |
Secondary | Oxygenation therapy | Registration of oxygen therapy (L/min) | During the entire admission to the intermediate care unit (expected to be approx. 3-5 days) oxygen therapy will be registered every 2 hours for the first 24 hours of admittance, and every 4 hours thereafter until discharge. | |
Secondary | Oxygenation saturation | Registration of oxygen saturation (%) | During the entire admission to the intermediate care unit (expected to be approx. 3-5 days) oxygen saturation will be registered every 2 hours for the first 24 hours of admittance, and every 4 hours thereafter until discharge. | |
Secondary | Respiratory rate | Registration of respiratory rate (number/minute) every 6th hours | Registered at admission to the intermediate care unit, every 6th hour for the first 24 hours thereafter, and every 24 hours for the duration of admission to the intermediate care unit (approx.3-5 days). | |
Secondary | Need of suction | Registration of every episode of suction (number/day) and from which part of the airway (mouth, pharynx, trachea) | During the entire admission to the intermediate care unit (approx.3-5 days), every episode of suction will be registered by the treating nurse, and total number of episodes will be registered every 24th hours until discharge. | |
Secondary | Treatment related adverse events | Registration of discontinuation of MIE, change in settings in MIE due to discomfort, reported adverse events after treatment. Registered in patient charts and/or reported by treating nurses/physiotherapists to principal investigator during patient admissions. No structural form used. | Registered daily on patient chart forms during entire admission to the intermediate care unit, and orally reported to the principal investigator during the admissions (approx. 3-5 days per patient). |
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