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Completed

NCT Number: NCT01931228

Mechanical Insufflation-Exsufflation in Preventing Post Extubation Respiratory Failure in Patient With Critical Care Neuromyopathy

Respiratory failure after extubation is a relevant consequence of poor airway clearance due to respiratory muscle weakness and respiratory failure after extubation and reintubation is associated with increased morbidity and mortality.

the study will evaluate the contribution of Mechanical Insufflation-Exsufflation (MI-E) in Preventing Respiratory Failure After Extubation as compared manually assisted coughing

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Bordeaux

Bordeaux, 33000, France

About this study

Critical Care Neuromyopathy (CCN) occur in 25% of patient in Intensive Care Unit (ICU). Respiratory failure after extubation is a relevant consequences of poor airway clearance due to respiratory muscle weakness. Respiratory failure is a major cause for reintubation which increase severity of illness, this is an independent risk factor for nosocomial pneumonia, increased hospital stay and mortality. Currently, respiratory physiotherapy includes, manual expiration assist often associated with nasotracheal aspiration. Despite of this care, respiratory failure occur in 30% of patients within 48 after planned extubation. MI-E has been evaluated for neuromuscular disease patient, and increase peak cough flow and the airway clearance. So the beneficials effects of MI-E should be confirmed in a trial in this specific population.

We planned to conduct a study evaluating the efficacy of MI-E in the prevention of extubation failure and mortality in these patients. If no signs of respiratory failure appeared after 120 min of a spontaneous breathing trial, patients will be extubated and randomly allocated after extubation to MI-E group or control group. The clinical follow-up will be as follow: the incidence of extubation failure, the reintubation, the ICU or 28-day survival,90-day survival, ICU length of stay.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male or female patient aged ≥ 18 years.
  • Patient admitted in participant ICU.
  • Patient intubated for 48 hours at least.
  • Patient presenting an ICU acquired neuromuscular disorders.

Exclusion criteria

  • Respiratory or haemodynamic instability.
  • Patient having a contraindication to use face mask (Recent facial surgery, severe craniofacial trauma,…) gastroesophageal surgery.
  • Severe ventricular rhythm disorders.
  • Patient with tracheotomy.
  • Uncontrollable vomiting.
  • Severe sepsis.
  • Upper airway disorders.
  • Upper gastrointestinal bleeding.
  • Any decision to limit therapeutic effort in the ICU.
  • Patient with limit therapeutic effort in the ICU with unsuccessful spontaneous respiratory trial.

Treatment and study plan

MI-E plus manually assisted coughing

Procedure

MI-E plus manually assisted coughing twice a day for 48h after extubation. After this period and before discharge of the icu or day28 maximum, patients received only one daily session.

manually assisted coughing

Procedure

Manually assisted coughing twice a day for 48h after extubation. After this period and before discharge of the icu or day28 maximum, patients received only one daily session.

Primary outcomes

  1. Incidence of respiratory failure after extubation

    Time frame: 48h post extubation (48h after inclusion)

Secondary outcomes

  1. the increase in peak cough flow

    Time frame: End of intensive care or day 28 after inclusion

  2. the incidence of reintubation

    Time frame: End of intensive care or day 28 after inclusion

  3. the average time of hospitalization in the intensive care unit

    Time frame: End of intensive care or day 28 after inclusion

  4. the incidence of nasotracheal suction

    Time frame: End of intensive care or day 28 after inclusion

  5. the number of additional physiotherapy sessions

    Time frame: End of intensive care or day 28 after inclusion

  6. the ICU mortality or 28-day survival

    Time frame: 28 days after inclusion

  7. 90 days survival

    Time frame: 90 days after inclusion

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Official study title

Contribution of Mechanical Insufflation-Exsufflation in Preventing Respiratory Failure Post Extubation in Patient With Critical Care Neuromyopathy

Acronym: NEUROMIE

Important dates

Study start
2012
Primary completion
2015
Study completion
2016
First posted
Aug 29, 2013
Registry last updated
Jan 23, 2018

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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