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OpenTrials
Completed

NCT Number: NCT04508270

Significance of Early Mobilization After VATS-L

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.

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Key information

Conditions

Lung Neoplasm Arterial Oxygen Saturation Behavior Exercise Lung Diseases Lung Function Lung Neoplasms Motor Activity Neoplasms Neoplasms by Site Physiology Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Rigshospitalet

Copenhagen, Denmark

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • VATS lobectomy;
  • Speak and understand Danish or English;
  • Informed consent obtained.

Exclusion criteria

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

Treatment and study plan

Early mobilization

Behavioral

Mobilization as soon as patients can, which is not limited on walking

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. The quantization of activity counts

    Time frame: Through study completion, an average of 3 days

  2. 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.

  3. length of stay in hospital

    Time frame: Through study completion, an average of 3 days

  4. Duration of chest tube

    Time frame: Through study completion, an average of 2 days

  5. 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.

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Registry information

Official study title

Physiological Evidence for Early Mobilization in Thoracoscopic Lobectomy

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Aug 11, 2020
Registry last updated
Dec 30, 2020

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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