Randomized Comparison of Awake Nonresectional Versus Nonawake Resectional Lung Volume Reduction Surgery

NCT00566839 | Completed Phase 2 DMC

• 2 other identifiers: MED2112025enfis12022
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Lung volume reduction surgery is effective in improving pulmonary function and quality of life in selected patients with severe emphysema although the morbidity of this surgical procedure is still considerable. Morbidity is mainly addressed to general anesthesia-related adverse effects and surgical trauma deriving from lung resection. Having developed an awake nonresectional lung volume reduction surgery technique, which is performed under sole thoracic epidural anesthesia, we have hypothesized that it could offer satisfactory clinical results and reduced morbidity rate when compared with the conventional surgical procedure.

Conditions

Pulmonary Emphysema

Keywords

COPD; LVRS; Awake surgery; Thoracic epidural anesthesia; One-lung ventilation; Emphysema; VATS; Lung surgery

Outcome Measures

Primary Outcomes (5)

• mortality

  3 months

• Hospital stay

  2 months

• Forced expiratory volume in one second

  24 months

• Residual volume

  24 months

• Modified Medical research Council Dyspnea index

  24 months

Secondary Outcomes (6)

• Arterial carbon dioxide tension (mmHg)

  2 days

• Arterial oxygen to fraction of inspired oxygen ratio (PaO2/FiO2)

  2 days

• Anesthesia satisfaction score (graded from 1=unsatisfactory to 4=Excellent)

  1 day (24h post-surgery)

• Six minute walking test distance (m)

  24 months

• Short form 36-item quality of life physical function domain score

  24 months

Study Arms (2)

1

EXPERIMENTAL

Procedure: awake nonresectional LVRS

2

ACTIVE COMPARATOR

Procedure: Nonawake resectional LVRS

Interventions

awake nonresectional LVRS PROCEDURE

Thoracoscopic nonresectional lung volume reduction surgery carried out in awake patients under sole epidural anesthesia through plication of most emphysematous target areas of the lung

1

Nonawake resectional LVRS PROCEDURE

Thoracoscopic lung volume reduction surgery carried out under general anesthesia and one-lung ventilation through nonanatomic resection of the most emphysematous target areas of the lung

2

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Severe smoking-related emphysema with upper-lobe predominance
• Severe disability (MMRC dyspnea grade\>=3) despite maximized medical therapy including respiratory rehabilitation
• No clinically significant sputum production, bronchiectasis or asthma postbronchodilator forced expiratory volume in onee second (FEV1)\<40% predicted
• Residual volume (RV)\>180% predicted at body plethysmography
• Total Lung capacity\>120% predicted
• No instable angina or ventricular arrythmia
• Peak systolic pulmonary artery pressure \<50 mmHg at echocardiocolordoppler
• Arterial carbon dioxide (PaCO2)\<50 mmHg
• Diffusion capacity of carbon monoxide (DLCO)\> 20% predicted
• Quit smoking since at least 4 months
• ASA score\<=3
• Body mass index \>18 \<29
• No comorbid condition that would significantly increase operative risk or negatively affect participation in a vigorous respiratory rehabilitation program
• No neoplastic disease with life expectancy \< 12 months
• No previous pleurodesis or thoracotomy in the more affected hemithorax

You may not qualify if:

• Radiologic evidence of extensive pleural adhesions with pleural scarring and calcifications on site targeted for LVRS
• Patients refusal or noncompliance to thoracic epidural anesthesia and awake surgery
• Patients refusal or noncompliance to general surgery and one-lung ventilation
• Unfavorable anatomy for thoracic epidural anesthesia
• Previous surgery of the cervical or upper thoracic spine
• Compromised coagulation (thromboplastin time\<80%, prothrombin time\>40 sec, platelet count\<100/nL or bleeding disorder

Sponsors & Collaborators

• University of Rome Tor Vergata: lead

Study Sites (1)

Policlinico Tor Vergata University

Rome, 00133, Italy

Location

Related Publications (13)

• Pompeo E, Marino M, Nofroni I, Matteucci G, Mineo TC. Reduction pneumoplasty versus respiratory rehabilitation in severe emphysema: a randomized study. Pulmonary Emphysema Research Group. Ann Thorac Surg. 2000 Sep;70(3):948-53; discussion 954. doi: 10.1016/s0003-4975(00)01646-5.

  PMID: 11016339 BACKGROUND

• Mineo TC, Pompeo E, Rogliani P, Dauri M, Turani F, Bollero P, Magliocchetti N. Effect of lung volume reduction surgery for severe emphysema on right ventricular function. Am J Respir Crit Care Med. 2002 Feb 15;165(4):489-94. doi: 10.1164/ajrccm.165.4.2108129.

  PMID: 11850341 BACKGROUND

• Pompeo E, Mineo TC; Pulmonary Emphysema Research group. Long-term outcome of staged versus one-stage bilateral thoracoscopic reduction pneumoplasty. Eur J Cardiothorac Surg. 2002 Apr;21(4):627-33; discussion 633. doi: 10.1016/s1010-7940(02)00038-6.

  PMID: 11932158 BACKGROUND

• Mineo TC, Ambrogi V, Pompeo E, Bollero P, Mineo D, Nofroni I; Pulmonary Emphysema Research Group. Body weight and nutritional changes after reduction pneumoplasty for severe emphysema: a randomized study. J Thorac Cardiovasc Surg. 2002 Oct;124(4):660-7. doi: 10.1067/mtc.2002.123807.

  PMID: 12324722 BACKGROUND

• Pompeo E, De Dominicis E, Ambrogi V, Mineo D, Elia S, Mineo TC. Quality of life after tailored combined surgery for stage I non-small-cell lung cancer and severe emphysema. Ann Thorac Surg. 2003 Dec;76(6):1821-7. doi: 10.1016/s0003-4975(03)01302-x.

  PMID: 14667591 BACKGROUND

• Mineo TC, Ambrogi V, Pompeo E, Elia S, Mineo D, Bollero P, Nofroni I. Impact of lung volume reduction surgery versus rehabilitation on quality of life. Eur Respir J. 2004 Feb;23(2):275-80. doi: 10.1183/09031936.03.00025203.

  PMID: 14979503 BACKGROUND

• Mineo TC, Pompeo E, Mineo D, Rogliani P, Leonardis C, Nofroni I. Results of unilateral lung volume reduction surgery in patients with distinct heterogeneity of emphysema between lungs. J Thorac Cardiovasc Surg. 2005 Jan;129(1):73-9. doi: 10.1016/j.jtcvs.2004.05.024.

  PMID: 15632827 BACKGROUND

• Tacconi F, Pompeo E, Mineo TC. Late-onset occult pneumothorax after lung volume-reduction surgery. Ann Thorac Surg. 2005 Dec;80(6):2008-12. doi: 10.1016/j.athoracsur.2005.06.013.

  PMID: 16305835 BACKGROUND

• Mineo TC, Pompeo E, Mineo D, Tacconi F, Marino M, Sabato AF. Awake nonresectional lung volume reduction surgery. Ann Surg. 2006 Jan;243(1):131-6. doi: 10.1097/01.sla.0000182917.39534.2c.

  PMID: 16371748 BACKGROUND

• Mineo TC, Pompeo E, Mineo D, Ambrogi V, Ciarapica D, Polito A. Resting energy expenditure and metabolic changes after lung volume reduction surgery for emphysema. Ann Thorac Surg. 2006 Oct;82(4):1205-11. doi: 10.1016/j.athoracsur.2006.05.030.

  PMID: 16996909 BACKGROUND

• Mineo TC, Pompeo E. Long-term results of tailored lung volume reduction surgery for severe emphysema. Clin Ter. 2007 Mar-Apr;158(2):127-33.

  PMID: 17566513 BACKGROUND

• Pompeo E, Mineo TC. Two-year improvement in multidimensional body mass index, airflow obstruction, dyspnea, and exercise capacity index after nonresectional lung volume reduction surgery in awake patients. Ann Thorac Surg. 2007 Dec;84(6):1862-9; discussion 1862-9. doi: 10.1016/j.athoracsur.2007.07.007.

  PMID: 18036900 BACKGROUND

• Pompeo E, Rogliani P, Tacconi F, Dauri M, Saltini C, Novelli G, Mineo TC; Awake Thoracic Surgery Research Group. Randomized comparison of awake nonresectional versus nonawake resectional lung volume reduction surgery. J Thorac Cardiovasc Surg. 2012 Jan;143(1):47-54, 54.e1. doi: 10.1016/j.jtcvs.2011.09.050. Epub 2011 Nov 4.

  PMID: 22056369 DERIVED

MeSH Terms

Conditions

Pulmonary Emphysema; Pulmonary Disease, Chronic Obstructive; Emphysema

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Eugenio Pompeo, MD

  Thoracic Surgery Division, Policlinico Tor Vergata University

  PRINCIPAL INVESTIGATOR

• Tommaso C Mineo, MD

  Thoracic Surgery Division, Policlinico Tor Vergata University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 30, 2007
• First Posted: December 4, 2007
• Study Start: December 1, 2002
• Study Completion: October 1, 2005
• Last Updated: December 4, 2007

Record last verified: 2007-10

Locations

IT (1)