Ventilation Therapy; Complications Clinical Trial
Official title:
In-line Mechanical Insufflation-Exsufflation as an Alternative to Invasive Suction for Secretion Management in Ventilated Patients
NCT number | NCT05365620 |
Other study ID # | 047-21 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | July 1, 2015 |
Est. completion date | July 1, 2018 |
Verified date | May 2022 |
Source | Alyn Pediatric & Adolescent Rehabilitation Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Catheter suction (CS), the standard method for airway secretion management during mechanical ventilation, is invasive and has significant hemodynamic and traumatic side effects. In-line mechanical insufflation-exsufflation (IL-MIE) is a new, noninvasive technology that clears secretions by cough-simulation, without interrupting ongoing ventilation. It is not known whether IL-MIE can be safely and effectively used as an alternative to CS in ventilated patients. Methods: A randomized, controlled, non-inferiority study comparing a standard protocol of CS, with automatic IL-MIE (CoughSync, Ruxin Medical Systems, Beijing) performed every 30 minutes, with CS added only if needed, in post-operative ventilated patients.
Status | Completed |
Enrollment | 120 |
Est. completion date | July 1, 2018 |
Est. primary completion date | July 1, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: - patients undergoing mechanical ventilation during the immediate recovery period following a cardiac or neuro-surgical procedure - Ventilation expected to last more than 8 hours Exclusion Criteria: - acute spinal cord shock - recent airway trauma or surgery - cardiogenic pulmonary edema or ARDS necessitating ventilation with a peak end expiratory pressure (PEEP) equal to or greater than 6 cmH2O - pneumothorax - hemoptysis - severe ischemic heart disease - lung tumors - pulmonary Tuberculosis - history of lung transplantation - pregnant or breastfeeding women |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Alyn Pediatric & Adolescent Rehabilitation Hospital | Beijing Anzhen Hospital |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | PaO2 | Arterial partial pressure of oxygen | change from baseline to 5 minutes | |
Primary | PaO2 | Arterial partial pressure of oxygen | change from baseline to 4 hours | |
Primary | PaO2 | Arterial partial pressure of oxygen | change from baseline to 8 hours | |
Primary | SaO2 | arterial oxygen saturation | change from baseline to 5 minutes | |
Primary | SaO2 | arterial oxygen saturation | change from baseline to 4 hours | |
Primary | SaO2 | arterial oxygen saturation | change from baseline to 8 hours | |
Primary | PaO2/FiO2 | oxygenation index - the ratio of blood oxygen to the percentage of inspired oxygen | change from baseline to 5 minutes | |
Primary | PaO2/FiO2 | oxygenation index - the ratio of blood oxygen to the percentage of inspired oxygen | change from baseline to 4 hours | |
Primary | PaO2/FiO2 | oxygenation index - the ratio of blood oxygen to the percentage of inspired oxygen | change from baseline to 8 hours | |
Secondary | PaCO2 | arterial partial pressure of carbon dioxide | change from baseline to 5 minutes | |
Secondary | PaCO2 | arterial partial pressure of carbon dioxide | change from baseline to 4 hours | |
Secondary | PaCO2 | arterial partial pressure of carbon dioxide | change from baseline to 8 hours | |
Secondary | SpO2 | blood oxygen saturation | change from baseline to 5 minutes | |
Secondary | SpO2 | blood oxygen saturation | change from baseline to 4 hours | |
Secondary | SpO2 | blood oxygen saturation | change from baseline to 8 hours | |
Secondary | heart rate | heart rate | change from baseline to 5 minutes | |
Secondary | heart rate | heart rate | change from baseline to 4 hours | |
Secondary | heart rate | heart rate | change from baseline to 8 hours | |
Secondary | inspired oxygen | percent fraction inspired oxygen | change from baseline to 5 minutes | |
Secondary | inspired oxygen | percent fraction inspired oxygen | change from baseline to 4 hours | |
Secondary | inspired oxygen | percent fraction inspired oxygen | change from baseline to 8 hours | |
Secondary | ventilator tidal volume | tidal volume in ml | change from baseline to 5 minutes | |
Secondary | ventilator tidal volume | tidal volume in ml | change from baseline to 4 hours | |
Secondary | ventilator tidal volume | tidal volume in ml | change from baseline to 8 hours | |
Secondary | ventilator peak inspiratory pressure | peak airway pressure in CMH2O | change from baseline to 5 minutes | |
Secondary | ventilator peak inspiratory pressure | peak airway pressure in CMH2O | change from baseline to 4 hours | |
Secondary | ventilator peak inspiratory pressure | peak airway pressure in CMH2O | change from baseline to 8 hours | |
Secondary | ventilator peak airway plateau pressure | airway plateau pressure in CMH2O | change from baseline to 5 minutes | |
Secondary | ventilator peak airway plateau pressure | airway plateau pressure in CMH2O | change from baseline to 4 hours | |
Secondary | ventilator peak airway plateau pressure | airway plateau pressure in CMH2O | change from baseline to 8 hours | |
Secondary | ventilator peak end expiratory pressure | airway end expiratory pressure in CMH2O | change from baseline to 5 minutes | |
Secondary | ventilator peak end expiratory pressure | airway end expiratory pressure in CMH2O | change from baseline to 4 hours | |
Secondary | ventilator peak end expiratory pressure | airway end expiratory pressure in CMH2O | change from baseline to 8 hours |
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