Significance of Early Mobilization After VATS-L

NCT04508270 | Completed DMC

• 1 other identifier: H-20041481
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lung Neoplasm; Physiology; Exercise; Lung Function; Arterial Oxygen Saturation

Keywords

Postoperative mobilization; Physiology; Thoracoscopy; Lobectomy

Outcome Measures

Primary Outcomes (2)

• 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.

  Through study completion, an average of 3 days

• 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.

  Through study completion, an average of 3 days

Secondary Outcomes (5)

• The quantization of activity counts

  Through study completion, an average of 3 days

• The quantization of pain

  Through study completion, an average of 3 days

• length of stay in hospital

  Through study completion, an average of 3 days

• Duration of chest tube

  Through study completion, an average of 2 days

• Postoperative complications

  up to 30 days

Interventions

Early mobilization BEHAVIORAL

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

Eligibility Criteria

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

Study Population

Patients scheduled for VATS-L.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Rigshospitalet

Copenhagen, Denmark

Location

Related Publications (12)

• 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.

  PMID: 28097305 BACKGROUND

• 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.

  PMID: 9175983 BACKGROUND

• 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.

  PMID: 30304509 BACKGROUND

• 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.

  PMID: 23219632 BACKGROUND

• 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.

  PMID: 8712320 BACKGROUND

• 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.

  PMID: 29892929 BACKGROUND

• 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.

  PMID: 25860350 BACKGROUND

• 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.

  PMID: 16857371 BACKGROUND

• 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.

  PMID: 29352586 BACKGROUND

• 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.

  PMID: 24646333 BACKGROUND

• 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.

  PMID: 16717296 BACKGROUND

• 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.

  PMID: 34470657 DERIVED

MeSH Terms

Conditions

Lung Neoplasms; Motor Activity

Interventions

Early Ambulation

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Behavior

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics

Study Officials

• Lin Huang, MD

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

• Henrik Kehlet, Professor, MD, DMSc

  Rigshospitalet, Denmark

  STUDY DIRECTOR

• Rene H Petersen, Professor, MD, PhD

  Rigshospitalet, Denmark

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor, Research fellow, PhD student

Study Record Dates

• First Submitted: July 31, 2020
• First Posted: August 11, 2020
• Study Start: September 8, 2020
• Primary Completion: December 18, 2020
• Study Completion: December 18, 2020
• Last Updated: December 30, 2020

Record last verified: 2020-12

Locations

DK (1)