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

This study has been completed.
Sponsor:
Information provided by:
University of Rome Tor Vergata
ClinicalTrials.gov Identifier:
NCT00566839
First received: November 30, 2007
Last updated: NA
Last verified: October 2007
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Pulmonary Emphysema
Procedure: awake nonresectional LVRS
Procedure: Nonawake resectional LVRS
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Randomized Comparison of Thoracoscopic Lung Volume Reduction Surgery Performed by Resectional Surgical Technique Under General Anesthesia or by a Non-Resectional Technique in Awake Patients Under Sole Epidural Anesthesia

Resource links provided by NLM:


Further study details as provided by University of Rome Tor Vergata:

Primary Outcome Measures:
  • mortality [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • Hospital stay [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
  • Forced expiratory volume in one second [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Residual volume [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Modified Medical research Council Dyspnea index [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Arterial carbon dioxide tension (mmHg) [ Time Frame: 2 days ] [ Designated as safety issue: Yes ]
  • Arterial oxygen to fraction of inspired oxygen ratio (PaO2/FiO2) [ Time Frame: 2 days ] [ Designated as safety issue: Yes ]
  • Anesthesia satisfaction score (graded from 1=unsatisfactory to 4=Excellent) [ Time Frame: 1 day (24h post-surgery) ] [ Designated as safety issue: No ]
  • Six minute walking test distance (m) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Short form 36-item quality of life physical function domain score [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Body mass index (Kg/m2) [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: December 2002
Study Completion Date: October 2005
Arms Assigned Interventions
Experimental: 1 Procedure: awake nonresectional LVRS
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
Active Comparator: 2 Procedure: Nonawake resectional LVRS
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

Detailed Description:

There is increasing scientific evidence that resectional lung volume reduction (LVR) can induce long lasting clinical improvements in selected patients with upper-lobe predominant emphysema and that clinical benefit and survival are better than those achieved with maximized medical treatment. The most widely employed surgical technique entails unilateral or bilateral staple resection of the most emphysematous lung tissue performed under general anesthesia through open or thoracoscopic approaches.

However, the type of surgical approach did not modify the considerable procedure-related morbidity, which can be mainly addressed to general anesthesia and surgical trauma deriving from resection of emphysematous lung tissue. Indeed, following resectional LVR expected mortality and pulmonary morbidity are 5.5% and 30%, respectively. Time spent for postoperative recovering is often prolonged with about 30% of patients still hospitalized or in rehabilitation facilities at 1 month and 15% still not at home 2 months after the operation. As a result, the cost-effectiveness of LVR continue to be questioned.

In recent years, the concept of nonresectional LVR is being investigated and new bronchoscopic approaches have been developed in an attempt of reducing the typical shortcomings of resectional LVR. Within the framework of the proposed nonsurgical methods which differ somewhat in physiopathologic bases and mechanism of LVR, a common denominator is that, so far, all needed general anesthesia.

We have developed an awake nonresectional LVR surgery technique, which respects the basic concepts of resectional LVR but adds some theoretical advantages and is performed under sole thoracic epidural anesthesia.

Following an initial pilot study to assess feasibility and early results, we want to analyze in a randomized fashion the perioperative morbidity and comprehensive 2-year results of thoracoscopic lung volume reduction surgery performed by the awake nonresectional or nonawake resectional surgical techniques.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00566839

Locations
Italy
Policlinico Tor Vergata University
Rome, Italy, 00133
Sponsors and Collaborators
University of Rome Tor Vergata
Investigators
Principal Investigator: Eugenio Pompeo, MD Thoracic Surgery Division, Policlinico Tor Vergata University
Study Chair: Tommaso C Mineo, MD Thoracic Surgery Division, Policlinico Tor Vergata University
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Tommaso Claudio Mineo, Tor Vergata University
ClinicalTrials.gov Identifier: NCT00566839     History of Changes
Other Study ID Numbers: MED2112025, enfis12022
Study First Received: November 30, 2007
Last Updated: November 30, 2007
Health Authority: Italy: Comitato Etico Indipendente Azienda Ospedaliera Universitaria Policlinico Tor vergata

Keywords provided by University of Rome Tor Vergata:
COPD
LVRS
Awake surgery
Thoracic epidural anesthesia
One-lung ventilation
Emphysema
VATS
Lung surgery

Additional relevant MeSH terms:
Emphysema
Pulmonary Emphysema
Pathologic Processes
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Diseases
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 14, 2014