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.

Study Overview

• Status: Completed
• Conditions: Heart Diseases; Abdominal Cancer
• Intervention / Treatment: Other: Mobilization

• Study Type: Interventional
• Enrollment (Actual): 1492
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Mobilization and breathing training; Usual clinical care	Other: Mobilization; Mobilization and breathing exercises according to clinical care; Other Names: Breathing training

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
When mobilization starts 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	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	Duration of the mobilization performed, minutes	Within 24 hours after surgery
When any intervention with breathing exercises starts after surgery	Time from termination of anesthesia to when the breathing exercise starts	Within 24 hours after surgery
Breathing exercise- Content	Type of breathing exercise, as deep breathing, positive expiratory pressure or incentive spirometry.	Within 24 hours after surgery
Breathing exercise- Intensity	Intensity of breathing exercise prescribed, sessions/time.	Within 24 hours after surgery

Collaborators and Investigators

• Sponsor: Göteborg University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2021
• Primary Completion (Actual): February 28, 2022
• Study Completion (Actual): June 30, 2022

Study Registration Dates

• First Submitted: January 4, 2021
• First Submitted That Met QC Criteria: January 27, 2021
• First Posted (Actual): January 28, 2021

Study Record Updates

• Last Update Posted (Actual): August 16, 2022
• Last Update Submitted That Met QC Criteria: August 13, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Thoracic surgery; Abdominal surgery; Immobilization; Breathing training
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases
• Other Study ID Numbers: FoU i VGR: 275327

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No