NCT01285648

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable lung-cancer

Timeline
Completed

Started Nov 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2007

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

January 25, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 28, 2011

Completed
Last Updated

January 28, 2011

Status Verified

January 1, 2011

Enrollment Period

2.1 years

First QC Date

January 25, 2011

Last Update Submit

January 26, 2011

Conditions

Keywords

chest tubes,Continuous Positive Airway Pressure,lung resection, thoracic surgery,noninvasive ventilation,postoperative

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Pain score

    Reported pain score after lung resection, along the study, during one year

Study Arms (2)

Cpap

OTHER

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

Chest Physiotherapy

OTHER

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

Interventions

CpapPROCEDURE

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

Also known as: Noninvasive ventilation, lung resection
Chest PhysiotherapyCpap

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • medical diagnosis of lung cancer and an indication for lung resection (lobectomy, bilobectomy and pneumonectomy) with posterolateral thoracotomy;
  • aged between 40 and 75 years.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Campinas State University

Campinas, São Paulo, 13083887, Brazil

Location

Related Publications (1)

  • Roceto Ldos S, Galhardo FD, Saad IA, Toro IF. Continuous positive airway pressure (CPAP) after lung resection: a randomized clinical trial. Sao Paulo Med J. 2014;132(1):41-7. doi: 10.1590/1516-3180.2014.1321525.

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Continuous Positive Airway PressureNoninvasive Ventilation

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Positive-Pressure RespirationRespiration, ArtificialAirway ManagementTherapeuticsRespiratory Therapy

Study Officials

  • Lígia S. Roceto

    University of Campinas, Brazil

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 25, 2011

First Posted

January 28, 2011

Study Start

November 1, 2007

Primary Completion

December 1, 2009

Study Completion

February 1, 2010

Last Updated

January 28, 2011

Record last verified: 2011-01

Locations