Oxygen Consumption (VO2), Effort, and Weaning in the Mechanically Ventilated Patient in the Intensive Care Unit (ICU)

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorLeiden University Medical Center

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Spontaneous Breathing Trial

    Diagnostic test

    Patients will undergo an SBT to determine whether they are ready for extubation.

Treatment groups

60 Participants
are divided into 1 treatment group
Group A: Spontaneous Breathing Trial1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
48 hours after SBT
2

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.

Time frame
10 minutes before, through SBT (average of 30 minutes) and 10 minutes after SBT

Secondary outcomes

1

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.

Time frame
10 minutes before, through SBT (average of 30 minutes) and 10 minutes after SBT
2

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.

Time frame
10 minutes before, through SBT (average of 30 minutes) and 10 minutes after SBT
3

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.

Time frame
10 minutes before, through SBT (average of 30 minutes) and 10 minutes after SBT
4

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.

Time frame
10 minutes before, through SBT (average of 30 minutes) and 10 minutes after SBT

Other outcomes

Sponsors and contacts

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