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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03347578
Other study ID # OLV DD
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 2016
Est. completion date February 2017

Study information

Verified date May 2018
Source Università degli Studi di Ferrara
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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).


Recruitment information / eligibility

Status Completed
Enrollment 75
Est. completion date February 2017
Est. primary completion date November 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

Diagnostic Test:
Ultrasonography
Diaphragmatic ultrasound was performed to investigate diaphragmatic function after thoracic surgery

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Università degli Studi di Ferrara

Outcome

Type Measure Description Time frame Safety issue
Primary Diaphragmatic dysfunction Diaphragmatic dysfunction is descripted as a diaphragmatic excursione lower than 10 mm 24 hours after surgery
Secondary Postoperative pulmonary complications Postoperative pulmonary complications include hypoxemia, severe hypoxemia, bronchospasm, suspected pulmonary infection, new pulmonary infiltrates, atelectasis, pleural effusion 7 days after surgery
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