Mobilization Immediate After Abdominal Surgery

NCT02929446 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 285

Last updated 2020-09-30

No results posted yet for this study

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. 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. 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.

or to
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.

Outcome assessment: The primary outcomes are arterial oxygen pressure (PaO2), and peripheral oxygen saturation (SpO2) over time and between groups. Secondary outcomes are arterial carbon dioxide pressure (PaCO2), pH, bGlu, lactate (arterial blood gas sample) over time and between groups; lung function assessed as forced vital capacity (FVC), forced expiratory flow in the one second (FEV1) and peak expiratory flow (PEF) by a micro spirometer ( preoperatively and the day after surgery); postoperative pneumonia and total length of stay at the postoperative recovery unit and at the hospital.

After the intervention both patients (n 25) and staff (n 20) will be interviewed about experiences of early mobilization.

Clinical significance: If a fairly simple and cheap intervention, such as mobilization immediately after open abdominal surgery, can lead to imporved oxygen saturation, shortened stay at hospital in total, it should be included as a routine in postoperative care.

Conditions

  • Respiratory Insufficiency
  • Postoperative Pulmonary Complications

Interventions

PROCEDURE

Mobilisation

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

PROCEDURE

Mobilisation and breathing exercises

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

Sponsors & Collaborators

Principal Investigators

  • Malin Nygren-Bonnier, PhD · Karolinska Institutet

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-31
Primary Completion
2018-12-31
Completion
2020-09-30

Countries

  • Sweden

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02929446 on ClinicalTrials.gov