Significance of Early Mobilization After VATS-L

December 29, 2020 updated by: Lin Huang, Rigshospitalet, Denmark

Physiological Evidence for Early Mobilization in Thoracoscopic Lobectomy

The main endpoint is physiological rehabilitation after VATS-L under early mobilization. The secondary endpoints are exploring the effect of early mobilization on postoperative physiology.

Investigators hypothesis that early mobilization is clearly advantaged to advance the physiological recovery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

24

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark
        • Rigshospitalet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients scheduled for VATS-L.

Description

Inclusion Criteria:

  1. VATS lobectomy;
  2. Speak and understand Danish or English;
  3. Informed consent obtained.

Exclusion Criteria:

  1. Co-VATS lobectomy (more than one lobe resection);
  2. Supplementary oxygen therapy later 6 h after surgery;
  3. No willing to wear electronic device;
  4. No willing to exam arterial oxygen saturation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative forced expiratory volume in one second (FEV1)
Time Frame: Through study completion, an average of 3 days
FEV1 is the amount of air you can force from your lungs in one second. Participants will be examed via spirometer.
Through study completion, an average of 3 days
Postoperative arterial oxygen saturation.
Time Frame: Through study completion, an average of 3 days
Oxygen saturation is the fraction of oxygen-saturated hemoglobin relative to total hemoglobin (unsaturated + saturated) in the blood. Participants will be tested via oximeter.
Through study completion, an average of 3 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The quantization of activity counts
Time Frame: Through study completion, an average of 3 days
Through study completion, an average of 3 days
The quantization of pain
Time Frame: Through study completion, an average of 3 days
The numeric rating scale (NRS) ranging from 0 (no pain) to 10 (excruciating pain) is used to score postoperative pain.
Through study completion, an average of 3 days
length of stay in hospital
Time Frame: Through study completion, an average of 3 days
Through study completion, an average of 3 days
Duration of chest tube
Time Frame: Through study completion, an average of 2 days
Through study completion, an average of 2 days
Postoperative complications
Time Frame: up to 30 days
Pneumothorax, subcutaneous emphysema, pneumonia, empyema, bleeding, pulmonary embolism, prolong air leakage, re-intervention, re-surgery and re-admission will be recording specifically.
up to 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 8, 2020

Primary Completion (Actual)

December 18, 2020

Study Completion (Actual)

December 18, 2020

Study Registration Dates

First Submitted

July 31, 2020

First Submitted That Met QC Criteria

August 8, 2020

First Posted (Actual)

August 11, 2020

Study Record Updates

Last Update Posted (Actual)

December 30, 2020

Last Update Submitted That Met QC Criteria

December 29, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-20041481

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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