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Survey Of Mobilisation and Breathing Exercises After Thoracic and Abdominal Surgery (SOMBATA)

13. august 2022 opdateret af: Göteborg University

Background

Thoracic or abdominal surgeries are followed by a shorter or longer period of immobilization and after major surgery there is a higher risk of developing cardiorespiratory complications. To prevent these complications, the patient is encouraged to change position and exercise in bed, get out of bed as early and as much as possible after the operation and to breathe with or without aids. There is no general definition of early mobilization and may start within a few hours to a few days after surgery. There is currently a lack of knowledge nationally and internationally about when the mobilization starts and what it contains.

Many patients also receive breathing training in connection with the surgery. There is currently no consensus on which method is preferable for which groups of patients. There are similarities and differences in practice in the world regarding postoperative breathing training. There are studies that have mapped practice after primarily thoracic surgery but also abdominal surgery. However, there are no studies that have mapped when the prescribed breathing training starts after different types of operations.

The purpose of the study is to map when mobilization and breathing training starts after abdominal and thoracic surgery and what is then performed

Method The study will be carried out as a quality follow-up with mapping of practice. Patients ≥ 18 years of age who are undergoing a planned or acute open, keyhole or robot-assisted surgery, who are extubated and who breathe spontaneously will be included. Exclusion criteria are completed plastic, trauma, orthopedic or transplant surgery.

The material will be recruited from Swedish university hospitals and county hospitals for 20 days of surgery (Monday through Thursday) for five consecutive weeks.

Clinical benefit The study will mean that clinical practice is presented which, with regard to mobilization, is the first study ever that will present when this takes place and what is done and, with regard to breathing training, the first that shows when this training is initiated.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

1492

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Sverige
    • Västra Götaland
      • Göteborg, Västra Götaland, Sverige, 41345
        • Sahlgrenska University Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • ≥ 18 years of age
  • undergoing a planned or acute open, laparoscopic or robot-assisted surgeon in the thorax or abdomen
  • who are extubated within 24 h of surgery
  • breathe spontaneously within 24 h of surgery

Exclusion Criteria:

  • reconstructive-, trauma-, transplantation- or orthopedic surgery.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Andet
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Andet: Mobilization and breathing training
Usual clinical care
Andet: Mobilization
Mobilization and breathing exercises according to clinical care
Andre navne:
  • Breathing training

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
When mobilization starts after surgery
Tidsramme: Within 24 hours after surgery
Time from termination of anaesthesia to when mobilization starts, ie when the patients are sitting with the legs over the edge of the bed
Within 24 hours after surgery
Mobilization- Content
Tidsramme: Within 24 hours after surgery
Content of the mobilization performed i.e. which level of mobilization (sitting on the edge of the bed, standing by the bed, sitting in a chair and walking) which is reached.
Within 24 hours after surgery
Mobilization- Duration
Tidsramme: Within 24 hours after surgery
Duration of the mobilization performed, minutes
Within 24 hours after surgery
When any intervention with breathing exercises starts after surgery
Tidsramme: Within 24 hours after surgery
Time from termination of anesthesia to when the breathing exercise starts
Within 24 hours after surgery
Breathing exercise- Content
Tidsramme: Within 24 hours after surgery
Type of breathing exercise, as deep breathing, positive expiratory pressure or incentive spirometry.
Within 24 hours after surgery
Breathing exercise- Intensity
Tidsramme: Within 24 hours after surgery
Intensity of breathing exercise prescribed, sessions/time.
Within 24 hours after surgery

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Göteborg University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. september 2021

Primær færdiggørelse (Faktiske)

28. februar 2022

Studieafslutning (Faktiske)

30. juni 2022

Datoer for studieregistrering

Først indsendt

4. januar 2021

Først indsendt, der opfyldte QC-kriterier

27. januar 2021

Først opslået (Faktiske)

28. januar 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

16. august 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

13. august 2022

Sidst verificeret

1. august 2022

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • FoU i VGR: 275327

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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