Mechanical Ventilation Complication Clinical Trial
Official title:
Determining the Appropriate Setting of an Automated Secretion Removal Technology (TrachFlush) Danish Title: Bestemmelse af Den Optimale Indstilling for en Teknologi Til Automatisk Fjernelse af Luftvejssekret (Trachflush)
Verified date | December 2022 |
Source | Hospitalsenheden Vest |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Using a new device, the TrachFlush, the aim of this pilot study is to investigate whether secretions can be removed at the patient's current ventilator settings, or whether pressures and durations considered at the maximal end of clinical practice are required, so as to push secretions around the cuff. The study is a pilot study to investigate the settings required to ensure clinical efficacy of the technology, prior to large scale clinical studies.
Status | Completed |
Enrollment | 20 |
Est. completion date | February 10, 2022 |
Est. primary completion date | February 8, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Orally intubated and mechanically ventilated - Patients for whom it is expected that secretions will be present during their ventilation period, as assessed by clinical evaluation. Exclusion Criteria: - Admission due to tracheal damage, e.g. inhalation trauma. - Severe ARDS (acute respiratory distress syndrome), indicated by a PaO2/FiO2 ratio lower than 100 mmHg or PEEP > 15 cmH2O. - Circulatory instability indicated by use of vasopressor (Norepinephrine) >0.1 micro gm/kg/min, heart rate >120, arrhythmia other than atrial fibrillation. - Patients with agitated delirium. - Mechanical ventilation via tracheostomy - Mechanical ventilation is provided with a mask or other non-invasive means - Pregnancy |
Country | Name | City | State |
---|---|---|---|
Denmark | Regional Hospital Herning | Herning | Region Midtjylland |
Denmark | Regional Hospital Viborg | Viborg | Region Midtjylland |
Lead Sponsor | Collaborator |
---|---|
Hospitalsenheden Vest | Aalborg University, Herning Hospital, Viborg Regional Hospital |
Denmark,
Efrati S, Deutsch I, Antonelli M, Hockey PM, Rozenblum R, Gurman GM. Ventilator-associated pneumonia: current status and future recommendations. J Clin Monit Comput. 2010 Apr;24(2):161-8. doi: 10.1007/s10877-010-9228-2. Epub 2010 Mar 17. Erratum In: J Clin Monit Comput. 2012 Dec;26(6):493. — View Citation
Frandsen JB, O'Reilly Poulsen KS, Laerkner E, Stroem T. Validation of the Danish version of the Critical Care Pain Observation Tool. Acta Anaesthesiol Scand. 2016 Oct;60(9):1314-22. doi: 10.1111/aas.12770. Epub 2016 Jul 29. — View Citation
Gelinas C, Fillion L, Puntillo KA, Viens C, Fortier M. Validation of the critical-care pain observation tool in adult patients. Am J Crit Care. 2006 Jul;15(4):420-7. — View Citation
Granja C, Lopes A, Moreira S, Dias C, Costa-Pereira A, Carneiro A; JMIP Study Group. Patients' recollections of experiences in the intensive care unit may affect their quality of life. Crit Care. 2005 Apr;9(2):R96-109. doi: 10.1186/cc3026. Epub 2005 Jan 31. — View Citation
Li J, Zong Y, Zhou Q, Dai H, Wang C. Evaluation of the Safety and Effectiveness of the Rapid Flow Expulsion Maneuver to Clear Subglottic Secretions in Vitro and in Vivo. Respir Care. 2017 Aug;62(8):1007-1013. doi: 10.4187/respcare.05348. Epub 2017 Apr 4. — View Citation
Maggiore SM, Lellouche F, Pignataro C, Girou E, Maitre B, Richard JC, Lemaire F, Brun-Buisson C, Brochard L. Decreasing the adverse effects of endotracheal suctioning during mechanical ventilation by changing practice. Respir Care. 2013 Oct;58(10):1588-97. doi: 10.4187/respcare.02265. Epub 2013 Mar 6. Erratum In: Respir Care. 2013 Dec;58(12):e173. — View Citation
Turner JS, Briggs SJ, Springhorn HE, Potgieter PD. Patients' recollection of intensive care unit experience. Crit Care Med. 1990 Sep;18(9):966-8. doi: 10.1097/00003246-199009000-00012. — View Citation
Zanella A, Florio G, Rezoagli E, Pastore M, Cadringer P, Biancolilli O, Carlesso E, Scaravilli V, Ristagno G, Pesenti AM. An Artificial Cough Maneuver to Remove Secretions From Below the Endotracheal Tube Cuff. Respir Care. 2019 Apr;64(4):372-383. doi: 10.4187/respcare.06076. Epub 2019 Jan 8. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Ability to remove secretion from tube | Success - clinical state is such that endotracheal suctioning is no longer required; Failure - clinical state has not improved sufficiently. | Immediately after the procedure. | |
Secondary | Procedures performed using increased settings. | Number of patients needing increased ventilator settings. | Immediately after the procedure | |
Secondary | Patient comfort | Evaluated using the Critical-care Pain Observation Tool (CPOT), a scale from 0-8 points, higher values indicating higher levels of pain/distress in the mechanically ventilated patient. | Immediately after the procedure | |
Secondary | Hypoxia | Indicated as more than 10% decrease of SpO2. | Immediately after the procedure |
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