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

NCT03714321 | Completed DMC

• 1 other identifier: S-20130102/j.nr. 2008-58-0035
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Pneumonia

Keywords

mechanical insufflation-exsufflation

Outcome Measures

Primary Outcomes (2)

• 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)

• 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 Outcomes (5)

• Oxygenation therapy

  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.

• Oxygenation 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.

• Respiratory rate

  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).

• Need of suction

  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.

• Treatment related adverse events

  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).

Study Arms (2)

Mechanical insufflation-exsufflation arm

EXPERIMENTAL

MIE will be given as prescribed by physician responsible at the intermediate care unit, typically every 4 hours. MIE will be administered 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. 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.

Device: Mechanical insufflation-exsufflation (MIE)

CPAP arm

NO INTERVENTION

CPAP will be given as prescribed by the physician responsible at the intermediate care unit, typically every 4 hours. CPAP will be administered with standard settings of H2O and an oxygen flow of 15L/min.

Interventions

Mechanical insufflation-exsufflation (MIE) DEVICE

Randomization of 30 patients, 15 in each arm, to receive either CPAP or MIE.

Also known as: NIPPY Clearway

Mechanical insufflation-exsufflation arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Community acquired or nosocomial pneumonia, diagnosed by new infiltrate on an x-ray chest and symptoms and/or objective findings acute lower airway infection
• years or older
• able to participate in CPAP treatment 10 cm H2O for 5 minutes
• able to provide written consent

You may not qualify if:

• pneumothorax less than 4 weeks prior to admission
• current pleural tube

Sponsors & Collaborators

• Odense University Hospital: lead

Related Publications (13)

• Ellison RT III, Donowitz GR. Acute pneumonia. In: Bennett JE, Dolin R, Blaser MJ. Mandell, Douglas, and Bennett's Principles and Practice of Infectious Diseases. 8th Edn. Philadelphia, Elsevier Saunders, 2015; pp. 829-831.

  BACKGROUND

• Homnick DN. Mechanical insufflation-exsufflation for airway mucus clearance. Respir Care. 2007 Oct;52(10):1296-305; discussion 1306-7.

  PMID: 17894900 RESULT

• 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.

  PMID: 19863831 RESULT

• Winck JC, Goncalves MR, Lourenco 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. doi: 10.1378/chest.126.3.774.

  PMID: 15364756 RESULT

• 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 acquired pneumonia in adults: update 2009. Thorax. 2009 Oct;64 Suppl 3:iii1-55. doi: 10.1136/thx.2009.121434. No abstract available.

  PMID: 19783532 RESULT

• 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.

  PMID: 21533875 RESULT

• Blasi F, Garau J, Medina J, Avila 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(1):44. doi: 10.1186/1465-9921-14-44.

  PMID: 23586347 RESULT

• Delclaux C, L'Her E, Alberti C, Mancebo J, Abroug F, Conti G, Guerin C, Schortgen F, Lefort Y, Antonelli M, Lepage E, Lemaire F, Brochard L. Treatment of acute hypoxemic nonhypercapnic respiratory insufficiency with continuous positive airway pressure delivered by a face mask: A randomized controlled trial. JAMA. 2000 Nov 8;284(18):2352-60. doi: 10.1001/jama.284.18.2352.

  PMID: 11066186 RESULT

• 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, controlled trial. Chest. 2010 Jul;138(1):114-20. doi: 10.1378/chest.09-2290. Epub 2010 Feb 12.

  PMID: 20154071 RESULT

• 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(7):942-9. doi: 10.1007/s00134-014-3325-5. Epub 2014 May 10.

  PMID: 24817030 RESULT

• MR810 technical manual. file:///C:/Users/lege4/Downloads/9e551a10-ef64-4514-a1bf-ce17cf08451e.pdf Date last accessed: July 12th 2017.

  RESULT

• NIPPY Clearway user manual. http://nippyventilator.com/wp-content/uploads/2016/02/2007v5-February2015-Clearway-IFU-English.pdf Date last updated: February 2015. Date last accessed: July 12th 2017.

  RESULT

• Lim WS, van der Eerden MM, Laing R, Boersma WG, Karalus N, Town GI, Lewis SA, Macfarlane JT. Defining community acquired pneumonia severity on presentation to hospital: an international derivation and validation study. Thorax. 2003 May;58(5):377-82. doi: 10.1136/thorax.58.5.377.

  PMID: 12728155 RESULT

MeSH Terms

Conditions

Pneumonia

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Isik Johansen, Prof.

  Odense University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist Registrar

Model Details: Randomized non-blinded controlled pilot study

Study Record Dates

• First Submitted: October 10, 2018
• First Posted: October 22, 2018
• Study Start: January 1, 2014
• Primary Completion: October 9, 2015
• Study Completion: October 9, 2015
• Last Updated: October 22, 2018

Record last verified: 2018-10