NCT03347578

Brief Summary

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).

Trial Health

100
On Track

Trial Health Score

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

Enrollment
75

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2016

Shorter than P25 for all trials

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

February 1, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

November 15, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 20, 2017

Completed
Last Updated

May 8, 2018

Status Verified

May 1, 2018

Enrollment Period

9 months

First QC Date

November 15, 2017

Last Update Submit

May 2, 2018

Conditions

Surgery, ThoracicRespiratory DiaphragmComplication, Postoperative

Outcome Measures

Primary Outcomes (1)

  • Diaphragmatic dysfunction

    Diaphragmatic dysfunction is descripted as a diaphragmatic excursione lower than 10 mm

    24 hours after surgery

Secondary Outcomes (1)

  • Postoperative pulmonary complications

    7 days after surgery

Study Arms (1)

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

Interventions

UltrasonographyDIAGNOSTIC_TEST

Diaphragmatic ultrasound was performed to investigate diaphragmatic function after thoracic surgery

Lung cancer surgery

Eligibility Criteria

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

Patients undergoing lung resection surgery for cancer

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Postoperative Complications

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physician

Study Record Dates

First Submitted

November 15, 2017

First Posted

November 20, 2017

Study Start

February 1, 2016

Primary Completion

November 1, 2016

Study Completion

February 1, 2017

Last Updated

May 8, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share