- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT04729634
Survey Of Mobilisation and Breathing Exercises After Thoracic and Abdominal Surgery (SOMBATA)
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.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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Västra Götaland
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Göteborg, Västra Götaland, Schweden, 41345
- Sahlgrenska University Hospital
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Kind
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Sonstiges
- Zuteilung: N / A
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Sonstiges: Mobilization and breathing training
Usual clinical care
|
Mobilization and breathing exercises according to clinical care
Andere Namen:
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
When mobilization starts after surgery
Zeitfenster: 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
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Within 24 hours after surgery
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Mobilization- Content
Zeitfenster: Within 24 hours after surgery
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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
Zeitfenster: Within 24 hours after surgery
|
Duration of the mobilization performed, minutes
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Within 24 hours after surgery
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When any intervention with breathing exercises starts after surgery
Zeitfenster: Within 24 hours after surgery
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Time from termination of anesthesia to when the breathing exercise starts
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Within 24 hours after surgery
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Breathing exercise- Content
Zeitfenster: Within 24 hours after surgery
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Type of breathing exercise, as deep breathing, positive expiratory pressure or incentive spirometry.
|
Within 24 hours after surgery
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Breathing exercise- Intensity
Zeitfenster: Within 24 hours after surgery
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Intensity of breathing exercise prescribed, sessions/time.
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Within 24 hours after surgery
|
Mitarbeiter und Ermittler
Sponsor
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- FoU i VGR: 275327
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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