The primary objective of the study is to investigate if the VO2, Pressure Time Product, Work of Breathing and transpulmonary Pressure Swings predict weaning failure or extubation failure after een succesfull SBT.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Beademde patienten
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Weaning- or extubation failure (or success) after a successful SBT.
Furthermore, the differences between start and end of SBT and absolute values
of the following parameters: VO2, Pressure Swings, Work of Breathing, Pressure
Time Product, Rapid Shallow Breathing Index.
Secondary outcome
Not applicable
Background summary
Rationale: 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 - 25 % 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 trans-pulmonary pressure swings.
Therefore, we want to investigate if these parameters are associated with an
weaning success or failure.
Study objective
The primary objective of the study is to investigate if the VO2, Pressure Time
Product, Work of Breathing and transpulmonary Pressure Swings predict weaning
failure or extubation failure after een succesfull SBT.
Study design
A single center prospective cohort study performed on patients undergoing a
weaning trial. Measurements will be performed the five minutes before a SBT,
during, and the five minutes afterwards. The measurements will be derived from
the Hamilton C6 mechanical ventilator and the Masimo ISA OR+. The SBT will be
performed according to the ruling protocol (Appendix 15.1) in the LUMC. The
investigation team will not make the decision to extubate and will not
influence the medical team.
Study burden and risks
It is necessary to connect the Masimo ISA OR+ to the tubing of the respiratory
system, for which the tubing must be disconnected from the ventilator for a
short moment. This is a daily routine on the ICU per protocol (e.g. when
changing the anti-bacterial filters attached to the ventilator) and happens
without incidents. The collection of data has no influence on daily care.
Albinsudreef 2
Leiden 2333 ZA
NL
Albinsudreef 2
Leiden 2333 ZA
NL
Listed location countries
Age
Inclusion criteria
18 years of age ore older
> 24 hours mechanically ventilated
- Eligible for a spontaneous breathing trial according to the clinical team
- Regular SBT ("Regulier SBT") according to the LUMC protocol
- Hemodynamically stable
- Esophageal Catheter in situ
Exclusion criteria
Known pregnancy
Severe 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.
Design
Recruitment
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL84568.058.23 |