Significance of Early Mobilization After VATS-L

Exercise Clinical Trial

Official title:

Physiological Evidence for Early Mobilization in Thoracoscopic Lobectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04508270
• Other study ID #: H-20041481
• Status: Completed
• Start date: September 8, 2020
• Est. completion date: December 18, 2020

Study information

• Verified date: December 2020
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 18, 2020
• Est. primary completion date: December 18, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arterial Oxygen Saturation
• Exercise
• Lung Function
• Lung Neoplasm
• Lung Neoplasms
• Physiology

Intervention

Behavioral:
• Early mobilization
Mobilization as soon as patients can, which is not limited on walking

Locations

Country	Name	City	State
Denmark	Rigshospitalet	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

References & Publications (11)

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®) 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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Kehlet H. Multimodal approach to control postoperative pathophysiology and rehabilitation. Br J Anaesth. 1997 May;78(5):606-17. Review. — View Citation

Kirkeby-Garstad I, Wisløff U, Skogvoll E, Stølen T, Tjønna 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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. Epub 2006 Jul 20. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	The quantization of activity counts		Through study completion, an average of 3 days
Secondary	The quantization of pain	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
Secondary	length of stay in hospital		Through study completion, an average of 3 days
Secondary	Duration of chest tube		Through study completion, an average of 2 days
Secondary	Postoperative complications	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