About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
The intended population consists of adults who are mechanically ventilated in the ICU and meet the criteria for a regular spontaneous breathing trial according to the ruling LUMC protocol.
Trial design
Cohort
Prospective
Treatments tested in this trial
Spontaneous Breathing Trial
Diagnostic testPatients will undergo an SBT to determine whether they are ready for extubation.
Treatment groups
Trial outcomes
Primary outcomes
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.
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.
Secondary outcomes
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.
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.
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.
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.
Sponsors and contacts
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