Mobilization Immediate After Abdominal Surgery

NCT02929446 | Completed

• 1 other identifier: MIDAS
• Study Type: interventional
• Target: 285
• Locations: 1 country
• Sites: 1

Brief Summary

Advances in surgical technique have led to a more complex surgery on patients with more serious comorbidities and the risk of postoperative pulmonary complications (PPC) is considerable . The isolated effect of mobilization immediately after surgery has previously not been studied. The aim of the study is to evaluate the effects of immediate mobilization (within 2 hours after arrival to the postoperative recovery unit) after abdominal surgery and also the patients and the staffs experiences of early mobilization. Methods: A randomized controlled trial will be conducted. A total of 300 Swedish-speaking, adult patients (≥18 years) planned for elective open or robot assisted laparascopic abdominal surgery with an expected anesthetic duration exceeding 2 hours are eligible for consecutive enrollment in the study. Patients who cannot mobilize independently before surgery, will be excluded. Procedure: Randomization to:

1. 1.Mobilization within 2 hours after arrival to the postoperative recovery unit after surgery - to sit up as long as they can in a chair, or on the bedside + breathing exercises standardized every hour, with a PEP-device or to
2. 2.Mobilization within 2 hours after arrival to the postoperative recovery unit after surgery - to sit up as long as they can in a chair, or on the bedside.
3. 3.No mobilization - laying or sitting in bed with a maximum of 30° elevation of the head rest. No mobilization out of the bed or breathing exercises until discharge or a maximum of 6 hours.

Conditions

Respiratory Insufficiency; Postoperative Pulmonary Complications

Keywords

mobilisation; physiotherapy

Outcome Measures

Primary Outcomes (2)

• Arterial oxygen saturation

  measured with blood gases

  1 year

• Peripheral oxygen saturation

  measured with pulse oximetry

  1 year

Secondary Outcomes (7)

• Arterial carbon dioxide

  1 year

• pH, lactate and Bglu

  1 year

• forced vital capacity (FVC)

  1 year

• forced expiratory volume in one second (FEV1)

  1 year

• Peak expiratory flow (PEF)

  1 year

Study Arms (3)

Mobilisation

EXPERIMENTAL

Mobilisation out of bed to sit in an armchair or on the bedside, instructed to sit as long as possible

Procedure: Mobilisation

Control

NO INTERVENTION

No mobilisation or breathing exercises until discharge or maximum 6 hours

Mobilisation and breathing exercises (PEP)

EXPERIMENTAL

Mobilisation out of bed to sit in an armchair or on the bedside, instructed to sit as long as possible and breathing exercises with PEP

Procedure: Mobilisation and breathing exercises

Interventions

Mobilisation PROCEDURE

Mobilisation out of bed to sit in an armchair or on the bedside, instructed to sit as long as possible

Mobilisation

Mobilisation and breathing exercises PROCEDURE

Mobilisation out of bed to sit in an armchair or on the bedside, instructed to sit as long as possible and breathing exercises with PEP

Mobilisation and breathing exercises (PEP)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Swedish-speaking, adult patients (≥18 years) planned for elective open or robot assisted laparascopic abdominal surgery with anesthetic time exceeding 2 hours, at Karolinska University Hospital Solna

You may not qualify if:

• Patients who cannot mobilize independently before surgery will be excluded, or if not able to understand instructions.

Sponsors & Collaborators

• Karolinska Institutet: lead
• Karolinska University Hospital: collaborator

Study Sites (1)

Karolinska University Hospital

Stockholm, 17176, Sweden

Location

Related Publications (1)

• Svensson-Raskh A, Schandl AR, Stahle A, Nygren-Bonnier M, Fagevik Olsen M. Mobilization Started Within 2 Hours After Abdominal Surgery Improves Peripheral and Arterial Oxygenation: A Single-Center Randomized Controlled Trial. Phys Ther. 2021 May 4;101(5):pzab094. doi: 10.1093/ptj/pzab094.

  PMID: 33742678 DERIVED

MeSH Terms

Conditions

Respiratory Insufficiency

Interventions

Breathing Exercises

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Exercise Movement Techniques; Physical Therapy Modalities

Study Officials

• Malin Nygren-Bonnier, PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The interventions were not possible to mask for patients or healthcare professionals at the recovery unit. The research nurses and the physiotherapists, who performed the postoperative spirometry, were blinded to the group randomization. All data were coded, and group assignment was blinded for outcome analyses
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: RPT, PhD, Senior lecturer

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: October 5, 2016
• First Posted: October 11, 2016
• Study Start: December 1, 2016
• Primary Completion: December 1, 2018
• Study Completion: September 1, 2020
• Last Updated: September 30, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)