Ultrasound Assessment of Diaphragmatic Dysfunction in Regional Anesthesia

Completed

• Conditions: Diaphragm Issues; Thoracic Surgery; Ultrasounds; Regional Anesthesia

• Registration Number: NCT04700943
• Lead Sponsor: University of Turin, Italy

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2019-02-01
• Primary Completion: 2020-09-30
• Status Verified: 2021-01
• Study Completion: 2021-01-01
• Study First Submitted: 2021-01-04
• Study First Submitted QC: 2021-01-07
• Last Update Submitted: 2021-01-07
• Study First Posted: 2021-01-08
• Last Update Posted: 2021-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Diaphragmatic maximal function	12 hours	Measured with diaphragmatic excursion

Secondary Outcome Measures

Name	Time	Method
Postoperative Nausea and Vomiting	24 hours	Presence/absence of Postoperative Nausea and Vomiting
Pain scores	24 hours	Numeric rate scale

Trial Locations

Locations (1)

AOU Città della Salute e della Scienza di Torino; 🇮🇹 Turin, Italy