Prospective Trial to Reduce Morbidity and Mortality After Lung Surgery in Patients With Reduced Pulmonary Capacity

University of Ulm

Status: Unknown

Conditions: Respiration Disorders

Treatments: Procedure: Fast track lung surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT00530491

BM 140/07

Details and patient eligibility

About

A fast track recovery program (thoracic epidural anesthesia, carbohydrate drink preoperative, early removal of chest tubes) is evaluated compared to conventional perioperative treatment (patient controlled analgesia, no carbohydrate drink preoperative) in patients with FEV1 < 70% of expected value or < 1.5L who undergo resections of the lung.

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• resection of the lung
• FEV1 <70% of expected value or below 1.5L
• 18-80y
• given written informed consent

Exclusion criteria

• contraindication for epidural anesthesia
• prio ipsilateral thoracotomy
• chemotherapy <6 weeks prior to study enter
• existing pneumonia (fever, elevated WCC, elevated CRP)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 2 patient groups

1

Active Comparator group

Description:

conventional perioperative management for lung surgery

Treatment:

Procedure: Fast track lung surgery

2

Experimental group

Description:

fast track management for lung surgery

Treatment:

Procedure: Fast track lung surgery