Weaning From Mechanical Ventilation Clinical Trial
— PREDRICOfficial title:
Comparison of the Incidence of 3 Inspiratory Muscle Training Programs on Inspiratory Strength, on Difficult to Wean Patients in Intensive Care Unit: a Multi-centre Randomised Trial.
Verified date | May 2020 |
Source | University Hospital, Bordeaux |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Ventilator-induced diaphragmatic dysfunction appears to contribute to slow weaning from
mechanical ventilation. Several trials of inspiratory muscle training to facilitate weaning
in intensive care have been performed, with inconsistent results, utilizing different methods
of IMT in different populations.
In this study, the investigators want to compare the incidence of 3 inspiratory muscle
training programs on inspiratory strength, on difficult to wean patients in intensive care
unit.
This is a multi-center randomized trial not blinded with 3 parallels groups:
- Martin's group: a threshold-based IMT is performed like used by Martin in a randomized
trial in 2011, in a view of inspiratory strength increase.
- Cader's group: a threshold-based IMT is performed like used by Cader in a randomized
trial in 2010 , in a view of inspiratory endurance increase.
- EDRIC's group: a new treshold-based IMT is performed, in a view of both inspiratory
strength and endurance increase.
The investigators think that a new threshold-based IMT performed in a view of both
inspiratory strength and endurance increase, is more effective and well tolerated than the 2
others protocols.
Status | Completed |
Enrollment | 92 |
Est. completion date | March 22, 2020 |
Est. primary completion date | February 22, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patient ventilated more than 18h in a controlled mode; - First single breathe trial of 2 hours failure; - Presence of sevrability criterias definied by the European consensus conference in 2007 an usually used: - diminution of the sedfative agents, - Patients with spontaneous beath in VAC mode or patient ventilated in a VSAI-PEP mode, - PaO2/FiO2 =150, - Absence d'inotropes ou de vasopresseurs à forte dose ou dose croissante (<1mg/h), - SaO2 > 90% with FiO2 = 50%, - PEP = 8cmH2O, - Corporal température between 36°C and 39°C, - Glasgow Score = 8. Exclusion Criteria: - Age < 18 years ; - medically unstable; - Poor vital pronostic at very short term; - Cardiac arrest with a poor neurological prognostic; - Neuromuscular disease ; - Pneumothorax non drained ; - Tracheostomy ; - Current pregnancy ; - Patients with guardianship or trusteeship. |
Country | Name | City | State |
---|---|---|---|
France | Réanimation Médicale | Bordeaux | |
France | Réanimation Médicale | Lyon |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Bordeaux |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Maximal Inspiratory Pressure score (inspiratory muscle strength index) performed by an external electronic device connected with a unidirectional valve. | Baseline and up to day 25 | ||
Secondary | Peak Pressure (inspiratory muscle endurance index) performed by an incremental threshold test. | Baseline and up to day 25 | ||
Secondary | Duration of the weaning period | up to day 25 | ||
Secondary | ICU lengh of stay | Day 30 | ||
Secondary | Weaning success | up to day 27 | ||
Secondary | Adverse events | Day 30 |
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