Critical Illness Clinical Trial
— EXTUBATEOfficial title:
Oxygen Consumption (VO2), Effort, and Weaning in the Mechanically Ventilated Patient in the Intensive Care Unit (ICU): EXTUBATE Study
NCT number | NCT06391424 |
Other study ID # | P23.068 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | January 1, 2024 |
Est. completion date | January 2026 |
In patients who are mechanically ventilated for more than 72 hours weaning failure is a common issue. The Spontaneous breathing trial (SBT) is often done to assess if the patient can be extubated with a high chance of success. However, re-intubation rates are between 15 - 20 % after a successful SBT. The rapid shallow breathing index (RSBI) is an important parameter used in an SBT. Because the high incidence of extubation failure (re-intubation within 48 hours) a search for a better parameter than the RSBI is warranted. Using the measured end-tidal oxygen (etO2) of mechanically ventilated patients it is possible to calculate the VO2, which is a measure of patient effort. The VO2 is a parameter with the potential to predict weaning success or failure, together with other parameters of patient effort like the work of breathing (WOB), pressure time product (PTP) and esophageal pressure swings, reflecting muscle strength of the diaphragm. Therefore, the investigators want to investigate if these parameters are associated with an SBT success or failure.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | January 2026 |
Est. primary completion date | October 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Age above 18 years - > 24 hours mechanically ventilated - Eligible for a spontaneous breathing trial according to the clinical team - Regular SBT ("Regulier SBT") according to the Leiden University Medical Center (LUMC) protocol - Hemodynamically stable - Esophageal Catheter in situ Exclusion Criteria: - Severe chronic obstructive pulmonary disease (COPD) (Gold class IV) if it results in a non regular SBT according to the LUMC protocol. - Heart failure (LVEF <30%) if it results in a non regular SBT according to the LUMC protocol - Known pregnancy |
Country | Name | City | State |
---|---|---|---|
Netherlands | Leiden University Medical Center | Leiden | |
Netherlands | Leiden University Medical Centre | Leiden | Zuid - Holland |
Lead Sponsor | Collaborator |
---|---|
Leiden University Medical Center |
Netherlands,
Beduneau G, Pham T, Schortgen F, Piquilloud L, Zogheib E, Jonas M, Grelon F, Runge I, Nicolas Terzi, Grange S, Barberet G, Guitard PG, Frat JP, Constan A, Chretien JM, Mancebo J, Mercat A, Richard JM, Brochard L; WIND (Weaning according to a New Definition) Study Group and the REVA (Reseau Europeen de Recherche en Ventilation Artificielle) Network double dagger. Epidemiology of Weaning Outcome according to a New Definition. The WIND Study. Am J Respir Crit Care Med. 2017 Mar 15;195(6):772-783. doi: 10.1164/rccm.201602-0320OC. — View Citation
Bellani G, Foti G, Spagnolli E, Milan M, Zanella A, Greco M, Patroniti N, Pesenti A. Increase of oxygen consumption during a progressive decrease of ventilatory support is lower in patients failing the trial in comparison with those who succeed. Anesthesiology. 2010 Aug;113(2):378-85. doi: 10.1097/ALN.0b013e3181e81050. — View Citation
Epstein SK, Ciubotaru RL, Wong JB. Effect of failed extubation on the outcome of mechanical ventilation. Chest. 1997 Jul;112(1):186-92. doi: 10.1378/chest.112.1.186. — View Citation
Jubran A, Grant BJ, Laghi F, Parthasarathy S, Tobin MJ. Weaning prediction: esophageal pressure monitoring complements readiness testing. Am J Respir Crit Care Med. 2005 Jun 1;171(11):1252-9. doi: 10.1164/rccm.200503-356OC. Epub 2005 Mar 11. — View Citation
Li F, Nie J, Lu Y, Tong TK, Yi L, Yan H, Fu FH, Ma S. The impact of intermittent exercise in a hypoxic environment on redox status and cardiac troponin release in the serum of well-trained marathon runners. Eur J Appl Physiol. 2016 Oct;116(10):2045-51. doi: 10.1007/s00421-016-3460-5. Epub 2016 Aug 29. — View Citation
McClave SA, Kleber MJ, Lowen CC. Indirect calorimetry: can this technology impact patient outcome? Curr Opin Clin Nutr Metab Care. 1999 Jan;2(1):61-7. doi: 10.1097/00075197-199901000-00011. — View Citation
Pham T, Telias I, Beitler JR. Esophageal Manometry. Respir Care. 2020 Jun;65(6):772-792. doi: 10.4187/respcare.07425. — View Citation
Takala J, Keinanen O, Vaisanen P, Kari A. Measurement of gas exchange in intensive care: laboratory and clinical validation of a new device. Crit Care Med. 1989 Oct;17(10):1041-7. doi: 10.1097/00003246-198910000-00015. — View Citation
Trudzinski FC, Neetz B, Bornitz F, Muller M, Weis A, Kronsteiner D, Herth FJF, Sturm N, Gassmann V, Frerk T, Neurohr C, Ghiani A, Joves B, Schneider A, Szecsenyi J, von Schumann S, Meis J. Risk Factors for Prolonged Mechanical Ventilation and Weaning Failure: A Systematic Review. Respiration. 2022;101(10):959-969. doi: 10.1159/000525604. Epub 2022 Aug 17. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of weaning failure | weaning failure is defined as not meeting the criteria for a succesful spontaneous breathing trial (SBT) or extubation failure, defined as the need for re-intubation within 48 hours, after a succesful SBT and subsequent extubation. | 48 hours after SBT | |
Primary | Differences of oxygen consumption during SBT | The values of oxygen consumption (in milliliter/minute) and the differences between start, during, and end of the SBT. | 10 minutes before, through SBT (average of 30 minutes) and 10 minutes after SBT | |
Secondary | Differences of esophageal pressure swings measured with an esophageal catheter during SBT | The values of pressure swings (in cmH2O), measured with an esophageal catheter, and the differences between start, during, and end of the SBT. | 10 minutes before, through SBT (average of 30 minutes) and 10 minutes after SBT | |
Secondary | Differences of work of breathing measured with an esophageal catheter during SBT | The values of work of breathing (in Joules/liter), measured with an esophageal catheter, and the differences between start, during, and end of the SBT. | 10 minutes before, through SBT (average of 30 minutes) and 10 minutes after SBT | |
Secondary | Differences of pressure time product measured with an esophageal catheter during SBT | The values of pressure time product (in cmH2O/seconds), measured with an esophageal catheter, and the differences between start, during, and end of the SBT. | 10 minutes before, through SBT (average of 30 minutes) and 10 minutes after SBT | |
Secondary | Differences of rapid shallow breathing index during SBT | The values of rapid shallow breathing index (breaths/minute/liter) and the differences between start, during, and end of the SBT. | 10 minutes before, through SBT (average of 30 minutes) and 10 minutes after SBT |
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