Clinical Trials Directory

Trials / Completed

CompletedNCT01424202

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
92 (actual)
Sponsor
Hospital Sao Joao · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

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.

Detailed description

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.

Conditions

Interventions

TypeNameDescription
DEVICEMechanical Insufflation ExsufflationAfter 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.

Timeline

Start date
2008-09-01
Primary completion
2010-06-01
Completion
2010-10-01
First posted
2011-08-26
Last updated
2011-08-26

Locations

1 site across 1 country: Portugal

Source: ClinicalTrials.gov record NCT01424202. Inclusion in this directory is not an endorsement.