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Completed

NCT Number: NCT01424202

Effects of Mechanical Insufflation-Exsufflation in Preventing Respiratory Failure After Extubation

Weaning protocols that include the use of noninvasive ventilation (NIV), decreases the incidence of re-intubation and ICU length of stay. However, the role of NIV in post-extubation failure is still not clear. Impaired airway clearance is associated with NIV failure. Mechanical Insufflation-Exsufflation (MI-E) is an assisted coughing technique that has been proven to be very effective in patients under NIV.

In this study the investigators assess the efficacy of MI-E as part of a protocol for patients that develop respiratory failure after extubation.

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Key information

Conditions

Post-extubation Failure Hypoventilation Pathological Conditions, Signs and Symptoms Persistent Weaning Failure Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases Secretion Encumbrance Signs and Symptoms Signs and Symptoms, Respiratory Ventilatory Failure Weak Cough

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Intensive Care and Emergency Department;, Faculty of Medicine, University Hospital of S. João

Porto, Porto District, 4200-319, Portugal

About this study

Patients under mechanical ventilation (MV) for more than 48 hours with specific inclusion criteria, who successfully tolerated an spontaneous breathing trial (SBT) were randomly allocated before extubation, either for (A) conventional extubation protocol (control group) or (B) MI-E extubation protocol (study group). Re-intubation rates, ICU length of stay and NIV failure rates were analyzed.

Inclusion of MI-E in post-extubation failure may reduce re-intubation rates with consequent reduction in post-extubation ICU length of stay. This technique seems to be efficient in improving the efficacy of NIV in this patient population.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients older than 18 years and under mechanical ventilation, for more than 48 hours, for acute hypoxemic and/or hypercapnic respiratory failure from a specific etiology

Exclusion criteria

  • facial or cranial trauma, tracheostomy, active upper gastrointestinal bleeding, neurologic instability (inability to respond to direct simple orders), hemodynamic instability, lack of cooperation and confirmed diagnosis of neuromuscular disease.

Treatment and study plan

Mechanical Insufflation Exsufflation

Device

After passing the SBT and randomized to group B, before extubation, all patients were submitted to a treatment of MI-E (3 sessions) through the endotracheal tube with pressures set at 40 cm H2O for insufflation and -40 cm H2O for exsufflation pressure. An insufflation/exsufflation time ratio of 3secs/2 secs and a pause of 3 sec between each cycle was used. Eight cycles were applied in every session with an abdominal thrust timed to the exsufflation cycle.

On top of the standard medical therapy, during the first 48 hours post extubation, each patient received 3 daily treatments by means of a light-weight, elastic oronasal mask. Treatments (3 sessions each) were divided between morning, afternoon and night, making a total of 9 daily sessions.

The daily treatment frequency and its outcomes were recorded in a diary by the nursing staff. All MI-E treatments were administered by a trained respiratory therapist, ICU physician or nurse.

Primary outcomes

  1. re-intubation rates

    Time frame: 48 hours

Secondary outcomes

  1. NIV failure rates

    Time frame: 48 hours

Sponsors and collaborators

Lead sponsor

Hospital Sao Joao

Other

Registry information

Acronym: MIEICU

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Aug 26, 2011
Registry last updated
Aug 26, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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