Study of CPAP as Intervention After Lung Resection

This study has been completed.
Sponsor:
Information provided by:
University of Campinas, Brazil
ClinicalTrials.gov Identifier:
NCT01285648
First received: January 25, 2011
Last updated: January 26, 2011
Last verified: January 2011
  Purpose

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.


Condition Intervention
Lung Cancer
Pulmonary Complications
Procedure: Cpap

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: APPLICATION OF CONTINUOUS POSITIVE AIRWAY PRESSURE IN POSTOPERATIVE OF LUNG RESECTION

Resource links provided by NLM:


Further study details as provided by University of Campinas, Brazil:

Primary Outcome Measures:
  • Bubbling drains [ Time Frame: From immediate postoperative until fifth, along the study, in a total of one year ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Pain score [ Time Frame: Reported pain score after lung resection, along the study, during one year ] [ Designated as safety issue: Yes ]
    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).


Enrollment: 40
Study Start Date: November 2007
Study Completion Date: February 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Cpap
This group joined chest physiotherapy with CPAP via nasal masks for two hours.CPAP was continued from the immediate postoperative day until the second postoperative day, twice a day.
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
Other Names:
  • Noninvasive ventilation
  • lung resection
Chest Physiotherapy
Chest Physiotherapy consisted of bronchial hygiene techniques and pulmonary expansion, in addition to exercises, and received oxygen supplementation to maintain the pulse oxymetry saturations > 90%.
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
Other Names:
  • Noninvasive ventilation
  • lung resection

Detailed 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.

  Eligibility

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01285648

Locations
Brazil
Campinas State University
Campinas, São Paulo, Brazil, 13083887
Sponsors and Collaborators
University of Campinas, Brazil
Investigators
Principal Investigator: Lígia S. Roceto University of Campinas, Brazil
  More Information

No publications provided by University of Campinas, Brazil

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: APPLICATION OF CONTINUOUS POSITIVE AIRWAY PRESSURE IN POSTOPERATIVE OF LUNG RESECTION, Unicamp
ClinicalTrials.gov Identifier: NCT01285648     History of Changes
Other Study ID Numbers: ROCETO130682
Study First Received: January 25, 2011
Last Updated: January 26, 2011
Health Authority: Brazil: Ethics Committee

Keywords provided by University of Campinas, Brazil:
chest tubes,
Continuous Positive Airway Pressure,
lung resection, thoracic surgery,
noninvasive ventilation,
postoperative

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 28, 2014