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

Primary Purpose

Abdominal Cancer, Heart Diseases

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Mobilization
Sponsored by
Göteborg University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Abdominal Cancer focused on measuring Immobilization, Abdominal surgery, Thoracic surgery, Breathing training

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Sahlgrenska University Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Mobilization and breathing training

Arm Description

Usual clinical care

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
January 4, 2021
Last Updated
August 13, 2022
Sponsor
Göteborg University
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1. Study Identification

Unique Protocol Identification Number
NCT04729634
Brief Title
Survey Of Mobilisation and Breathing Exercises After Thoracic and Abdominal Surgery
Acronym
SOMBATA
Official Title
Survey Of Mobilisation and Breathing Exercises After Thoracic and Abdominal Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
February 28, 2022 (Actual)
Study Completion Date
June 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Göteborg University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Cancer, Heart Diseases
Keywords
Immobilization, Abdominal surgery, Thoracic surgery, Breathing training

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
A cohort of patients followed over time
Masking
None (Open Label)
Masking Description
The patients will not be aware of the study activities
Allocation
N/A
Enrollment
1492 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mobilization and breathing training
Arm Type
Other
Arm Description
Usual clinical care
Intervention Type
Other
Intervention Name(s)
Mobilization
Other Intervention Name(s)
Breathing training
Intervention Description
Mobilization and breathing exercises according to clinical care
Primary Outcome Measure Information:
Title
When mobilization starts after surgery
Description
Time from termination of anaesthesia to when mobilization starts, ie when the patients are sitting with the legs over the edge of the bed
Time Frame
Within 24 hours after surgery
Title
Mobilization- Content
Description
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.
Time Frame
Within 24 hours after surgery
Title
Mobilization- Duration
Description
Duration of the mobilization performed, minutes
Time Frame
Within 24 hours after surgery
Title
When any intervention with breathing exercises starts after surgery
Description
Time from termination of anesthesia to when the breathing exercise starts
Time Frame
Within 24 hours after surgery
Title
Breathing exercise- Content
Description
Type of breathing exercise, as deep breathing, positive expiratory pressure or incentive spirometry.
Time Frame
Within 24 hours after surgery
Title
Breathing exercise- Intensity
Description
Intensity of breathing exercise prescribed, sessions/time.
Time Frame
Within 24 hours after surgery

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Monika Fagevik Olsén, PhD
Organizational Affiliation
Sahlgrenska University Hospital, Sweden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sahlgrenska University Hospital
City
Göteborg
State/Province
Västra Götaland
ZIP/Postal Code
41345
Country
Sweden

12. IPD Sharing Statement

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Survey Of Mobilisation and Breathing Exercises After Thoracic and Abdominal Surgery

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