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Prospective combined validation of an algorithmic calculated mean systemic filling pressure with transpulmonary pressure measurements during thoracic drainage and 3D TOE measured hemodynamic parameters.

Prospective combined validation of an algorithmic calculated mean systemic filling pressure with transpulmonary pressure measurements during thoracic drainage and 3D TOE measured hemodynamic parameters. - Validation of Pms, transpulmonary pressure in drainage and 3D TOE.

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON47962
Enrollment
20
Registered
2019-03-06
Start date
2019-06-24
Completion date
Unknown
Last updated
2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Circulatory failure

Interventions

None listed

Sponsors

Catharina-ziekenhuis
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - 18yrs or older - SIgned informed consent - Elective coronary artery bypass surgery - Postoperative mechnically ventilated admitted to the PACU

Exclusion criteria

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 outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Endpoint 2: 1. The pressure difference of Pes differs

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)