Ultrasound Assessment of Diaphragmatic Dysfunction in Regional Anesthesia

Thoracic Surgery Clinical Trial

Official title:

Ultrasound Assessment of Diaphragmatic Dysfunction: General Versus Regional Anesthesia for Video-assisted Thoracoscopic Surgery Pulmonary Biopsy in Interstitial Lung Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04700943
• Other study ID #: DULORATHO
• Status: Completed
• Start date: February 1, 2019
• Est. completion date: January 1, 2021

Study information

• Verified date: January 2021
• Source: University of Turin, Italy
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Awake thoracic surgery is a feasible and safe alternative to general anesthesia for pulmonary biopsy in interstitial lung disease patients, but there is still no evidence as to its superiority in terms of outcome. However, there is extensive literature about the effect of anesthetic drugs and surgery on diaphragmatic function. Furthermore, in thoracic surgery, diaphragmatic dysfunction was associated with a higher occurrence of postoperative pulmonary complications.

To assess the impact of general anesthesia on diaphragmatic function, the investigators conducted an observational prospective trial. The investigators measured both diaphragmatic excursion and Thickening Fraction at baseline and 12 hours after surgery together with pulmonary function tests and gas exchange data.

Description:

Awake thoracic surgery is a feasible and safe alternative to general anesthesia for pulmonary biopsy in interstitial lung disease patients, but there is still no evidence as to its superiority in terms of outcome.

However, there is extensive literature about the effect of anesthetic drugs and surgery on diaphragmatic function. Furthermore, in thoracic surgery, diaphragmatic dysfunction was associated with a higher occurrence of postoperative pulmonary complications.

To assess the impact of general anesthesia on diaphragmatic function, the investigators conducted an observational prospective trial. The investigators measured both diaphragmatic excursion and Thickening Fraction at baseline and 12 hours after surgery together with pulmonary function tests and gas exchange data.

The investigators divided our population into two groups: one group of patients undergoing awake thoracic surgery with epidural anesthesia, and the other group undergoing general anesthesia.

Forty-one patients were recruited and the Thickening Fraction percentage, calculated as (End Inspiratory thickness-End Expiratory thickness)/End Expiratory thickness, was evaluated by means of an ultrasound-assisted method, using a high frequency (10 MHz) linear probe.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: January 1, 2021
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients scheduled for lung biopsy from February 2019 to September 2020

Exclusion Criteria:

• pregnancy,

• Body Mass Index >35,

• Inability to provide informed consent,

• American Society of Anesthesiologists physical status classification score of IV

• Recommended postoperative ICU care

Related Conditions & MeSH terms

• Diaphragm Issues
• Regional Anesthesia
• Thoracic Surgery
• Ultrasounds

Intervention

Procedure:
• Regional awake anesthesia
We want to assess the impact of regional anesthesia on diaphragmatic function in patients undergoing Video-assisted thoracoscopic surgery pulmonary biopsy in interstitial lung disease

Locations

Country	Name	City	State
Italy	AOU Città della Salute e della Scienza di Torino	Turin

Sponsors (1)

Lead Sponsor	Collaborator
University of Turin, Italy

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diaphragmatic maximal function	Measured with diaphragmatic excursion	12 hours
Secondary	Pain scores	Numeric rate scale	24 hours
Secondary	Postoperative Nausea and Vomiting	Presence/absence of Postoperative Nausea and Vomiting	24 hours