1. Is PmsALG comparable with PmsINSP, even with changing Ppl?2. Is PmsARM comparable with PmsINSP and PmsALG?3. Does thoracic drainage have influence on pleural pressures measured by esophageal balloon catheter to determine transpulmonary pressure?4…
ID
Source
Brief title
Condition
- Heart failures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Endpoint 1:
1. PmsARM and PmsINSP give a reliable reflection of volume state.
2. A linear trend or correlation can be observed when comparing PmsALG with
PmsARM and PmsINSP.
Secondary outcome
Endpoint 2:
1. The pressure difference of Pes differs <5cm H2O compared to the peripheral
pleural pressure measured
2. The pressure difference of Per changes linear with the change in pleural
pressure during different negative drainage pressures.
Endpoint 3:
1. Cardiac parameters measured with perioperative 3D TOE change <10% in
comparison to PiCCO and carotid artery measurement.
Background summary
Volume-state in critically ill patients is a difficult parameter to determine,
and knowledge about it could make the difference between life or death
concerning proper treatment. Determination of volume state starts with adequate
3D transesophageal echocardiography (TOE) in the operation room, including with
non-invasive doppler carotid artery measures. TOE is a standardly used method
in cardiac surgery. Because echocardiography only gives information about
volume status at a certain timepoint, a real-time continuous value reflecting
volume-status is needed. "Mean systemic filling pressure (Pms)" appears to be a
promising value reflecting volume status. There are clinically and
patient-unfriendly methods available which to date serve as a gold standard to
determine Pms. However, these methods cannot be used in daily practice because
of the aforementioned reasons. Therefore there is a need for a non-invasive
methods measuring Pms, which could now be determined by an algorithm (PmsALG).
It is key to compare this PmsALG with its gold standards (inspiratory breath
hold; PmsINSP) and a more minimally invasive but certainly not patient-friendly
determination of Pms by blood pressure cuff measurement in an arm (PmsARM) in
order to establish a clinical validation for PmsALG.
While validating PmsALG, one has to consider the intrathoracic pressure by
performing esophageal pressure measurements (Ppl) using a esophageal balloon to
be able to calculate which pressure changes are exactly attributable to the Pms
measurement during an inspiratory breath hold. Coincidentally this gives
opportunity to determine what the clinical value of oesophageal pressure
measurements is during thoracic drainage in post cardiac surgery patients, for
this has never been investigated. By combining all these entities, the
investigators hope to be able to give a better estimation of intravascular
fluid status in order to prevent hyper/hypovolemia and eventually create a
better outcome for ICU-patients.
Study objective
1. Is PmsALG comparable with PmsINSP, even with changing Ppl?
2. Is PmsARM comparable with PmsINSP and PmsALG?
3. Does thoracic drainage have influence on pleural pressures measured by
esophageal balloon catheter to determine transpulmonary pressure?
4. What is the difference between cardiac parameters and non-invasive
perioperative values determined by 3D transoesophageal echocardiography (TEE)
compared with PiCCO and carotid echo doppler?
Study design
Prospective observational cohort analysis.
Study burden and risks
Minimal burden for the patient, as all study procedures will take place under
full sedation.
Inspiratory breath hold:
Standard method without risks.
Esophageal balloon catheter:
No hazard, small risk of bleeding (in theory) which has never occurred in
practice.
PiCCO catheter:
Standard Intensive Care equipment. Small risk of bleeding or catheter-related
infection (in theory) which has never occurred in practice.
Michelangelolaan 2
Eindhoven 5623 EJ
NL
Michelangelolaan 2
Eindhoven 5623 EJ
NL
Listed location countries
Age
Inclusion criteria
- 18yrs or older
- SIgned informed consent
- Elective coronary artery bypass surgery
- Postoperative mechnically ventilated admitted to the PACU
Exclusion criteria
- Withdrawal informed consent
- History of pneumonectomy of lobectomy
- Mechnical support of circulation
- COPD Gold 3 or 4
- Contra-indications for esophageal balloon: esophageal tumors, ulcerations,
diverticulitis, varices bleeding, recent esophageal surgery, sinusitis,
epistaxis, recent nasopharyngeal surgery.
- Complications during surgery
- Postoperative bleeding >50mL/15 minutes after admission to PACU
- No thoracic drain in pleura
- Postoperative pneumothorax
- Participation in other research studies/trials
- Elevated intra-abdominal surgery (>12 mmHg)
Design
Recruitment
Medical products/devices used
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 | NL67389.100.18 |