Diaphragmatic Echography After Thoracic Surgery (OLVDD)

May 2, 2018 updated by: Savino Spadaro, Università degli Studi di Ferrara

Evaluation of Diaphragmatic Displacement With Echography in Patients Undergoing Thoracic Surgery

The investigator evaluated diaphragmatic function in patients undergoing thoracic surgery. Diaphragmatic displacement was evaluated before surgery, 2 and 24 hours after surgery. Also, preoperative spirometry and postoperative spirometry were collected (24 hours after surgery).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

75

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients undergoing lung resection surgery for cancer

Description

Inclusion Criteria:

  • Elective surgery for lung cancer
  • Age > 18
  • ASA 2-3

Exclusion Criteria:

  • BMI > 35
  • Contraindications for epidural catheter positioning
  • History of neurodegenerative pathology
  • Previous thoracic surgery
  • Need for mechanical ventilation after surgery

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Lung cancer surgery
All patients undergoing thoracic surgery for lung cancer either with thoracoscopy or thoracotomy will receive diaphragmatic Ultrasonography 2 and 24 hours after surgery
Diagnostic test: Ultrasonography
Diaphragmatic ultrasound was performed to investigate diaphragmatic function after thoracic surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diaphragmatic dysfunction
Time Frame: 24 hours after surgery
Diaphragmatic dysfunction is descripted as a diaphragmatic excursione lower than 10 mm
24 hours after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative pulmonary complications
Time Frame: 7 days after surgery
Postoperative pulmonary complications include hypoxemia, severe hypoxemia, bronchospasm, suspected pulmonary infection, new pulmonary infiltrates, atelectasis, pleural effusion
7 days after surgery

Collaborators and Investigators

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

Sponsor

Università degli Studi di Ferrara

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

February 1, 2016

Primary Completion (Actual)

November 1, 2016

Study Completion (Actual)

February 1, 2017

Study Registration Dates

First Submitted

November 15, 2017

First Submitted That Met QC Criteria

November 15, 2017

First Posted (Actual)

November 20, 2017

Study Record Updates

Last Update Posted (Actual)

May 8, 2018

Last Update Submitted That Met QC Criteria

May 2, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OLV DD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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