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OpenTrials
Completed

NCT Number: NCT04729634

Survey Of Mobilisation and Breathing Exercises After Thoracic and Abdominal Surgery

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.

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Key information

Conditions

Abdominal Cancer Cardiovascular Diseases Heart Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sahlgrenska University Hospital

Gothenburg, Västra Götaland County, 41345, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mobilization

Other

Mobilization and breathing exercises according to clinical care

Other names: Breathing training

Primary outcomes

  1. When mobilization starts after surgery

    Time frame: 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

  2. Mobilization- Content

    Time frame: 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.

  3. Mobilization- Duration

    Time frame: Within 24 hours after surgery

    Duration of the mobilization performed, minutes

  4. When any intervention with breathing exercises starts after surgery

    Time frame: Within 24 hours after surgery

    Time from termination of anesthesia to when the breathing exercise starts

  5. Breathing exercise- Content

    Time frame: Within 24 hours after surgery

    Type of breathing exercise, as deep breathing, positive expiratory pressure or incentive spirometry.

  6. Breathing exercise- Intensity

    Time frame: Within 24 hours after surgery

    Intensity of breathing exercise prescribed, sessions/time.

Sponsors and collaborators

Lead sponsor

Göteborg University

Other

Registry information

Acronym: SOMBATA

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jan 28, 2021
Registry last updated
Aug 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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