NCT01826136

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
78

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2013

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 3, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 8, 2013

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

May 14, 2014

Status Verified

May 1, 2014

Enrollment Period

7 months

First QC Date

April 3, 2013

Last Update Submit

May 13, 2014

Conditions

Pulmonary Resection Surgery

Outcome Measures

Primary Outcomes (1)

  • FEV1 on the third postoperative day

    3 days after surgery

Study Arms (2)

Acapella

EXPERIMENTAL

use of the Acapella device postoperatively

Device: Acapella device

Control

NO INTERVENTION

Interventions

Acapella deviceDEVICE
Acapella

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 3, 2013

First Posted

April 8, 2013

Study Start

January 1, 2013

Primary Completion

August 1, 2013

Study Completion

September 1, 2013

Last Updated

May 14, 2014

Record last verified: 2014-05

Locations

KR(1)