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In-exsufflation mechanics in intubated patients

In-exsufflation mechanics in intubated patients: a randomized trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN25106564
Enrollment
67
Registered
2013-11-26
Start date
2014-01-01
Completion date
Unknown
Last updated
2018-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Respiratory Failure requiring mechanical ventilation and endotracheal tube intubation Respiratory Acute respiratory failure

Interventions

Inclusion: 1. Demographics 2. Duration of mechanical ventilation before inclusion 3. Pathology requiring intubation, history 4. Severity Score SAPS II and SOFA 5. Clinic: blood pressure, heart and res

Sponsors

Philips Respironics (France)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patient ventilated on endotracheal tube for less than 7 days 2. Duration of mechanical ventilation predicted > 48h;Inclusion criteria: 1. Patient ventilated on endotracheal tube for less than 7 days 2. Duration of mechanical ventilation predicted > 48h

Exclusion criteria

Exclusion criteria: 1. Pre-existing neuromuscular pathology, suspected or proven 2. State of shock uncontrolled defined by the administration of norepinephrine or adrenaline at a dose> 0.3 mcg/kg/min 3. Moderate to severe acute respiratory distress syndrome (ARDS) defined by a PaO2/FiO2 ratio 0.3 mcg/kg/min 3. Moderate to severe acute respiratory distress syndrome (ARDS) defined by a PaO2/FiO2 ratio <200 mmHg 4. Undrained pneumothorax 5. Hemoptysis active or less than 15 days 6. Intracranial hypertension 7. Decision to limit or stop the treatment 8. Pregnancy 9. Unable to follow study related procedures as explained by the investigator 10. Minor patient

Design outcomes

Primary

MeasureTime frame
The number of drainage procedures for tracheobronchial secretions necessary for 24h;The number of drainage procedures for tracheobronchial secretions necessary for 24h

Secondary

MeasureTime frame
1. The volume of bronchial secretions collected daily 2. The incidence of ventilator-acquired pneumonia defined by the presence of two of the following three criteria: 2.1. Hyperthermia > 38.3 ° C controlled to 4 hours apart 2.2. Leukocytosis > 10 G / l 2.3. Sputum purulent And the following two criteria: 2.4. Microbiological documentation as defined in the study protocol 2.5. New X-ray image evaluated by the two-point increase Score Weinberg 26 3. The incidence of atelectasis (radiographic or endoscopic diagnosis) 4. The clinical safety of the technique assessed by a visual analogue rating scale in conscious patients 5. The failure of the test airway defined by the occurrence of: 5.1. Increased heart rate of more than 30/min 5.2. Increased respiratory rate of more than 10/min 5.3. Respiratory distress with clinical signs of struggle 5.4. Change in systolic blood pressure over 30 mmHg 5.5. Desaturation of more than 4% SpO2 5.6. Increased the capnia more than 5 mmHg 6. The failure of extubation is defined by the need for reintubation within 72 hours. Reintubation criteria as defined in the study protocol 6.1. Criterion immediate intubation: 6.1.1. Cardiac or respiratory arrest 6.1.2. Respiratory break with loss of consciousness or dying breath 6.1.3. Psychomotor agitation not controlled by sedation 6.1.4. Dimensions persistent 6.1.5. Inhalation massive 6.1.6. Heart rate 7.35 or PaCO2 > 45 mmHg 6.2.2. SpO2 50% 6.3.3. Respiratory rate > 35/min 6.3.4. Disorder consciousness, agitation or asterixis 6.3.5. Clinical signs of respiratory control or exhaustion: use accessory respiratory muscles or swinging thoracoabdominal 7. The duration of invasive mechanical ventilation 8. The length of stay in the ICU 9. The length of hospital stay 10. Mortality in the ICU 11. In-hospital mortality;1. The volume of bronchial secretions collected daily 2. The incidence of ventilator-acquired pneumonia defined by the presence of two of the following three criteria: 2.1. Hyperther

Countries

France

Contacts

Public Contact; ;

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Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026