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Feasibility of Extended Non-invasive Haemodynamic Monitoring in the PACU

23. mars 2021 oppdatert av: Dr. Jochen Renner, University Hospital Schleswig-Holstein

Prospective Observational Study on the Use of Extended Haemodynamic Monitoring in the Post-Anesthesia Care Unit (PACU) Using Non-invasive Methods: Feasibility and Influence on Volume Therapy and Catecholamine Treatment.

Post-operative monitoring of all patients after anaesthesia in the post anaesthesia care unit (PACU) is standard of care today. It helps to reduce morbidity and even mortality in high-risk patients.

In addition to clinical monitoring by qualified personnel, this monitoring also includes, commonly non-invasive, intermittent, haemodynamic monitoring. This monitoring is also used to evaluate the transferability of patients from the PACU to the ward.

The aim of our study is to perform extended monitoring of volume status and haemodynamics with non-invasive monitoring methods such as transthoracic echocardiography and the volume clamp method in the recovery room.

Studieoversikt

Detaljert beskrivelse

Postoperative haemodynamic management, with particular emphasis on adequate volume status, is essential for patient outcome, as is optimised intraoperative management. Postoperative monitoring is usually performed in the PACU by non-invasive, continuous and intermittent monitoring. ECG and oxygen saturation are monitored continuously, blood pressure and laboratory analyses intermittently. The assessment of adequate oxygen supply (cardiac output - haemoglobin concentration - oxygen saturation) in the PACU is traditionally approximated only by surrogate parameters such as blood pressure and heart rate, in the sense of an empirical approach. The aim should be to transfer the available data on the benefit of early, goal-oriented haemodynamic optimisation by means of extended haemodynamic monitoring to the sensitive area of the PACU. An important prerequisite for the implementation of such haemodynamic optimisation protocols is the use of non-invasive monitoring methods, which ideally provide continuous flow and pressure-based parameters in combination with the use of intermittent transthoracic echocardiography. The necessity to continue extended haemodynamic monitoring in selected patients in the PACU on the basis of non-invasive procedures is under discussion and is not part of a defined standard today (Gruenewald et al. Anaesthesia 2015). A number of non-invasive haemodynamic monitoring methods have become available over the last few years, with a large number of scientific evaluation studies investigating the methods in various clinical settings in comparison to invasive systems. Of interest for routine clinical use are the so-called volume clamp procedures, which allow non-invasive, continuous recording of haemodynamic parameters such as stroke volume, cardiac output, blood pressure and plus pressure variation. Thus, in combination with oxygen saturation and intermittent haemoglobin determinations, they enable a punctual determination of oxygen supply (Meidert et al. Front Med (Lausanne) 2017 and Renner et al. Br J Anaesth 2017).

It is of interest whether the volume clamp method in particular provides the aforementioned parameters such as blood pressure, stroke volume, cardiac output and the pulse pressure variation continuously and without interference in the awake patient in the PACU. Another aspect is the assessment of the volume status and cardiac performance that patients show on admission to the PACU. Here, special attention is paid to the volume status after the patients have been haemodynamically optimised intraoperatively with an invasive procedure. Furthermore, we will compare how the cardiac output determined by echocardiography on admission differs from the cardiac output of the volume clamp method on admission. The differences between invasive blood pressure measurement and non-invasive pressure measurement will also be assessed.

In addition, the investigators analyse the frequencies of decreased blood pressures in comparison to a patient collective that was monitored according to standard-of-care in the PACU. Also, the comparative observation of the number of interventions performed, such as volume administration and/or catecholamine administration, between the groups.

Studietype

Observasjonsmessig

Registrering (Faktiske)

80

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

    • Deutschland (deu)
      • Kiel, Deutschland (deu), Tyskland, 24105
        • Universitätsklinikum Schleswig-Holstein Campus Kiel - Klinik für Anästhesiologie und Operative Intensivmedizin

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

patients with ASA classification I-III undergoing abdominal surgery, surgery in urology or vascular surgery and delivered to postanaesthesia care unit

Beskrivelse

Inclusion Criteria:

  • patients with ASA classification I-III undergoing abdominal surgery, surgery in urology or vascular surgery
  • written consent

Exclusion Criteria:

  • Age <18 years
  • ASA classification IV or higher
  • legal care relationship
  • missing or faulty written consent

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
length of stay in the recovery room
Tidsramme: up to 24 weeks
evaluated using the Whites-Fast-Trac Scoring System
up to 24 weeks
acute renal failure
Tidsramme: up to 24 weeks
number of short-term postoperative complications
up to 24 weeks
pericardial effusion
Tidsramme: up to 24 weeks
number of short-term postoperative complications
up to 24 weeks
pulmonary oedema
Tidsramme: up to 24 weeks
number of short-term postoperative complications
up to 24 weeks

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
cardiac output by echocardiography
Tidsramme: up to 24 weeks
cardiac output determined by echocardiography on admission
up to 24 weeks
cardiac output volume clamp method
Tidsramme: up to 24 weeks
cardiac output determined by volume clamp method on admission
up to 24 weeks
frequencies of decreased blood pressure values
Tidsramme: up to 24 weeks
frequencies of decreased blood pressure values between the groups
up to 24 weeks
number of interventions
Tidsramme: up to 24 weeks
comparative observation of the number of interventions performed between the groups
up to 24 weeks

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. april 2019

Primær fullføring (Faktiske)

31. januar 2021

Studiet fullført (Faktiske)

1. mars 2021

Datoer for studieregistrering

Først innsendt

16. juli 2019

Først innsendt som oppfylte QC-kriteriene

23. mars 2021

Først lagt ut (Faktiske)

24. mars 2021

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

24. mars 2021

Siste oppdatering sendt inn som oppfylte QC-kriteriene

23. mars 2021

Sist bekreftet

1. mars 2021

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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