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OpenTrials
Completed

NCT Number: NCT03054675

Perioperative Lung Function Monitoring After Anatomic Lung Resections

Aim of this study was to prospectively investigate the correlation between postoperative spirometry values and pulmonary complications after anatomic lung resections. In addition, the investigators compared postoperative pulmonary function changes between open and minimally invasive approaches.

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Key information

Conditions

Lung Function Decreased Lung Diseases Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Bern

Bern, Canton of Bern, 3010, Switzerland

About this study

All patients undergoing an anatomical lung resection at the investigators' institution were evaluated for this study. Underage patients and those undergoing extended resections (including resection of the chest wall and/or diaphragm) and/or bronchoplastic procedures were excluded.

In every eligible patient undergoing an anatomic lung resection, preoperative spirometry was performed using a handheld spirometer on the day before surgery and on every second day after surgery was performed until patient discharge. The absolute values of FEV1 were recorded by an independent study nurse and noted on a separate sheet not available to the treating doctors.

At the end of the study period FEV1 values were evaluated especially with focus on their correlation with postoperative pulmonary complications (i.e. pneumonia, acute exacerbation of COPD, air leak and atelectasis). Furthermore lung function values of patients undergoing 'open' resections were compared with patients undergoing minimally invasive resections.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients undergoing anatomical lung resection
  • Written informed consent

Exclusion criteria

  • Underage patients
  • Extended resections including resection of chest wall or diaphragm
  • Bronchoplastic resections

Treatment and study plan

Spirometry

Diagnostic Test

Absolute FEV1 is measured in every patient using a handheld spirometer

Primary outcomes

  1. Decrease in FEV1

    Time frame: up to 6 days after surgery

    Postoperative loss of FEV1 in percent of absolute preoperative levels

Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Registry information

Acronym: PLF

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Feb 15, 2017
Registry last updated
Feb 15, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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