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Lung NeoplasmNCT04508270

Significance of Early Mobilization After VATS-L

An observational study of Lung Neoplasm and Physiology, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lung Neoplasm, Physiology, Exercise
What is being tested?
Early mobilization
How many people
24 participants
Where
1 siteDenmark
Study dates
8 Sep 2020to 18 Dec 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients scheduled for VATS-L.

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • Rigshospitalet

    Copenhagen

Other trials in Denmark

About this study

Official title: 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.

Being tested
Early mobilization
Keywords
Postoperative mobilization, Physiology, Thoracoscopy, Lobectomy
Medical subject headings
Lung Neoplasms, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Early mobilizationBehavioural

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Postoperative forced expiratory volume in one second (FEV1)

    FEV1 is the amount of air you can force from your lungs in one second. Participants will be examed via spirometer.

    Measured: Through study completion, an average of 3 days

  2. Postoperative arterial oxygen saturation.

    Oxygen saturation is the fraction of oxygen-saturated hemoglobin relative to total hemoglobin (unsaturated + saturated) in the blood. Participants will be tested via oximeter.

    Measured: Through study completion, an average of 3 days

Secondary outcomes (5)

  1. The quantization of activity counts

    Measured: Through study completion, an average of 3 days

  2. The quantization of pain

    The numeric rating scale (NRS) ranging from 0 (no pain) to 10 (excruciating pain) is used to score postoperative pain.

    Measured: Through study completion, an average of 3 days

  3. length of stay in hospital

    Measured: Through study completion, an average of 3 days

  4. Duration of chest tube

    Measured: Through study completion, an average of 2 days

  5. Postoperative complications

    Pneumothorax, subcutaneous emphysema, pneumonia, empyema, bleeding, pulmonary embolism, prolong air leakage, re-intervention, re-surgery and re-admission will be recording specifically.

    Measured: up to 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Aug 2020
  2. Study start8 Sep 2020
  3. Primary completion18 Dec 2020
  4. Study completion18 Dec 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04508270
Sponsor's protocol ID
H-20041481
Status last verified
Dec 2020
First submitted
31 Jul 2020
Last updated
30 Dec 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Ljungqvist O, Scott M, Fearon KC. Enhanced Recovery After Surgery: A Review. JAMA Surg. 2017 Mar 1;152(3):292-298. doi: 10.1001/jamasurg.2016.4952.

    PubMed 28097305

  • Kehlet H. Multimodal approach to control postoperative pathophysiology and rehabilitation. Br J Anaesth. 1997 May;78(5):606-17. doi: 10.1093/bja/78.5.606.

    PubMed 9175983

  • Batchelor TJP, Rasburn NJ, Abdelnour-Berchtold E, Brunelli A, Cerfolio RJ, Gonzalez M, Ljungqvist O, Petersen RH, Popescu WM, Slinger PD, Naidu B. Guidelines for enhanced recovery after lung surgery: recommendations of the Enhanced Recovery After Surgery (ERAS(R)) Society and the European Society of Thoracic Surgeons (ESTS). Eur J Cardiothorac Surg. 2019 Jan 1;55(1):91-115. doi: 10.1093/ejcts/ezy301.

    PubMed 30304509

  • Haines KJ, Skinner EH, Berney S; Austin Health POST Study Investigators. Association of postoperative pulmonary complications with delayed mobilisation following major abdominal surgery: an observational cohort study. Physiotherapy. 2013 Jun;99(2):119-25. doi: 10.1016/j.physio.2012.05.013. Epub 2012 Sep 23.

    PubMed 23219632

  • Mynster T, Jensen LM, Jensen FG, Kehlet H, Rosenberg J. The effect of posture on late postoperative oxygenation. Anaesthesia. 1996 Mar;51(3):225-7. doi: 10.1111/j.1365-2044.1996.tb13637.x.

    PubMed 8712320

  • Hanada M, Kanetaka K, Hidaka S, Taniguchi K, Oikawa M, Sato S, Eguchi S, Kozu R. Effect of early mobilization on postoperative pulmonary complications in patients undergoing video-assisted thoracoscopic surgery on the esophagus. Esophagus. 2018 Apr;15(2):69-74. doi: 10.1007/s10388-017-0600-x. Epub 2017 Dec 16.

    PubMed 29892929

  • Liu Z, Tao X, Chen Y, Fan Z, Li Y. Bed rest versus early ambulation with standard anticoagulation in the management of deep vein thrombosis: a meta-analysis. PLoS One. 2015 Apr 10;10(4):e0121388. doi: 10.1371/journal.pone.0121388. eCollection 2015.

    PubMed 25860350

  • Ueda K, Sudoh M, Jinbo M, Li TS, Suga K, Hamano K. Physiological rehabilitation after video-assisted lung lobectomy for cancer: a prospective study of measuring daily exercise and oxygenation capacity. Eur J Cardiothorac Surg. 2006 Sep;30(3):533-7. doi: 10.1016/j.ejcts.2006.05.025. Epub 2006 Jul 20.

    PubMed 16857371

  • Rogers LJ, Bleetman D, Messenger DE, Joshi NA, Wood L, Rasburn NJ, Batchelor TJP. The impact of enhanced recovery after surgery (ERAS) protocol compliance on morbidity from resection for primary lung cancer. J Thorac Cardiovasc Surg. 2018 Apr;155(4):1843-1852. doi: 10.1016/j.jtcvs.2017.10.151. Epub 2017 Dec 19.

    PubMed 29352586

  • Chang NW, Lin KC, Lee SC, Chan JY, Lee YH, Wang KY. Effects of an early postoperative walking exercise programme on health status in lung cancer patients recovering from lung lobectomy. J Clin Nurs. 2014 Dec;23(23-24):3391-402. doi: 10.1111/jocn.12584. Epub 2014 Mar 20.

    PubMed 24646333

  • Kirkeby-Garstad I, Wisloff U, Skogvoll E, Stolen T, Tjonna AE, Stenseth R, Sellevold OF. The marked reduction in mixed venous oxygen saturation during early mobilization after cardiac surgery: the effect of posture or exercise? Anesth Analg. 2006 Jun;102(6):1609-16. doi: 10.1213/01.ANE.0000219589.03633.BF.

    PubMed 16717296

  • Huang L, Kehlet H, Petersen RH. Effect of posture on pulmonary function and oxygenation after fast-tracking video-assisted thoracoscopic surgery (VATS) lobectomy: a prospective pilot study. Perioper Med (Lond). 2021 Sep 2;10(1):26. doi: 10.1186/s13741-021-00199-z.

    PubMed 34470657

Questions about this trial

What is this clinical trial studying?

An observational study of Lung Neoplasm and Physiology, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Postoperative forced expiratory volume in one second (FEV1) (time frame: Through study completion, an average of 3 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04508270, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2020.

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