Effect of Vibratory Expiratory Pressure on Pulmonary Function After Lung Resection Surgery

May 13, 2014 updated by: Seoul National University Hospital
Postoperative airway clearance and recovery of pulmonary function after lung resection is critical in patients undergoing pulmonary resection surgery. The investigators hypothesized that vibratory positive expiratory pressure using the Acapella device may improve pulmonary function recovery in patients undergoing video-assisted thoracoscopic lung resection surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

78

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients between 20 and 65 years old
  • undergoing video-assisted thoracoscopic lung resection surgery for suspicious lung cancer
  • admission to intensive care unit in extubate state
  • with intravenous patient-controlled analgesia

Exclusion Criteria:

  • body mass index of less than 15 kg/m2 or more than 30 kg/m2
  • history of respiratory tract infection within 3 months
  • emergency surgery
  • preoperative supplemental oxygen or ventilator care
  • preoperative PaO2 of less than 70 mmHg or PaCO2 of more than 50 mmHg
  • preoperative FEV1 of less than 30% of predicted value
  • unconsciousness or neuromuscular disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Control
EXPERIMENTAL: Acapella
use of the Acapella device postoperatively
Device: Acapella device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
FEV1 on the third postoperative day
Time Frame: 3 days after surgery
3 days after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (ACTUAL)

August 1, 2013

Study Completion (ACTUAL)

September 1, 2013

Study Registration Dates

First Submitted

April 3, 2013

First Submitted That Met QC Criteria

April 5, 2013

First Posted (ESTIMATE)

April 8, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

May 14, 2014

Last Update Submitted That Met QC Criteria

May 13, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

  • YSJeon_Acapella

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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