Study of CPAP as Intervention After Lung Resection

Lung Cancer Clinical Trial

— CPAP  

Official title:

APPLICATION OF CONTINUOUS POSITIVE AIRWAY PRESSURE IN POSTOPERATIVE OF LUNG RESECTION

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01285648
• Other study ID #: ROCETO130682
• Status: Completed
• Phase: N/A
• First received: January 25, 2011
• Last updated: January 26, 2011
• Start date: November 2007
• Est. completion date: February 2010

Study information

• Verified date: January 2011
• Source: University of Campinas, Brazil
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The aim of this study was to compare the oxygenation index (OI), dyspnea, and pain scale and evaluate the duration of thoracic drainage and pleural air leaks after lung resection in two groups of patients: chest physiotherapy (CP) patients and combined CP and Continuous Positive Airway Pressure (CPAP) patients.

Description:

In pulmonary resection surgery complications that lead to significant functional losses of the lung parenchyma and alterations in the ventilatory function may trigger retention of secretions, atelectasis, pneumonia and respiratory failure, which prolong the duration of mechanical ventilation and hospitalisation and contribute to the increase in risk of mortality.

In this study the oxygenation index (OI), Borg Scale, pain scale and the presence and duration of thoracic drainage was determined in the immediate postoperative (POi) period and in the first and second postoperative (PO1, PO2) days in 40 patients who underwent elective lung resection.

Similar to Chest Physiotherapy, the preventive application of CPAP in the postoperative period after lung resection in our study also appeared to be a safe technique, which allowed improved oxygenation without increasing air leaks through the thoracic drains.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 75 Years

Eligibility

Inclusion Criteria:

• medical diagnosis of lung cancer and an indication for lung resection (lobectomy, bilobectomy and pneumonectomy) with posterolateral thoracotomy;

• aged between 40 and 75 years.

Exclusion Criteria:

• Patients who refused to participate in the survey;

• lung resection with incisions other than posterolateral;

• patients who had contraindications to the use of noninvasive ventilation.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lung Cancer
• Pulmonary Complications

Intervention

Procedure:
• Cpap
This study did not involved drugs. The Oxygenation index, Borg Scale, pain scale and the presence and duration of thoracic drainage was determined in the immediate postoperative (POi) period and in the first and second postoperative (PO1, PO2) days in 40 patients who underwent elective lung resection,in two groups of intervention: chest physiotherapy, and associate this with cpap

Locations

Country	Name	City	State
Brazil	Campinas State University	Campinas	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Campinas, Brazil

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bubbling drains	From the immediate postoperative day until hospital discharge, the presence of chest tubes and the occurrence of air leaks in them as evidenced by the bubbling of the water seal were recorded. The maintenance and removal of drains or their use with wall suction were determined by applying the medical protocol of the institution through the analysis of X-rays and the amount of drained fluid.	From immediate postoperative until fifth, along the study, in a total of one year	Yes
Secondary	Pain score	Before beginning the chest physiotherapy protocols, the patient was asked to rate their pain from zero to ten according to its intensity (the larger the score, the greater the intensity of pain).	Reported pain score after lung resection, along the study, during one year	Yes