NCT01566032

Brief Summary

The amount of air leaking from a chest tube can be measured in two main ways:

  1. 1.electronic monitor connected to the chest tube
  2. 2.numerical (non-electronic) monitor connected to the chest tube

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2012

Shorter than P25 for all trials

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

January 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 26, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 29, 2012

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
Last Updated

July 7, 2017

Status Verified

July 1, 2017

Enrollment Period

10 months

First QC Date

March 26, 2012

Last Update Submit

July 5, 2017

Conditions

Pulmonary Air Leak

Keywords

pulmonary air leakThopazanalogdigital

Outcome Measures

Primary Outcomes (1)

  • Inter-rater variability of air leak measurements.

    Time frame will occur once patients have experienced an air leak. 70% of patients are expected to have a PAL on postoperative day 1. There will be a 4 hour window to complete observations from the numerical device. These observations will be followed by observations on digital device. Each observer should spend 5-10 min to complete both tasks.

    Post-op

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

A target of 30 patients at the Ottawa Hospital who experienced pulmonary air leak following pulmonary resection will be recruited.

You may qualify if:

  • years of age or over
  • Male and Female.
  • Air leak occuring after any pulmonary resection
  • Air leak persisting on or after the first post-op day of pleural drainage
  • Air leak not entirely secondary to poor air seal at the pleural drainage incision site
  • Pulmonary resection for benign or neoplastic diagnosis

You may not qualify if:

  • Tension pneumothorax
  • Traumatic or iatrogenic pneumothorax
  • Primary or recurrent spontaneous pneumothorax awaiting surgery
  • Pneumonectomy patient (history of or current)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ottawa General Hospital

Ottawa, Ontario, K1H 8L6, Canada

Location

Study Officials

  • Sebastien Gilbert, MD

    Ottawa Hospital/Ottawa Hospital Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 26, 2012

First Posted

March 29, 2012

Study Start

January 1, 2012

Primary Completion

November 1, 2012

Study Completion

November 1, 2012

Last Updated

July 7, 2017

Record last verified: 2017-07

Locations

CA(1)