Clinical trial NCT04700943: Ultrasound Assessment of Diaphragmatic Dysfunction in Regional Anesthesia
Official title: Ultrasound Assessment of Diaphragmatic Dysfunction: General Versus Regional Anesthesia for Video-assisted Thoracoscopic Surgery Pulmonary Biopsy in Interstitial Lung Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Regional Anesthesia
Diaphragm Issues
Thoracic Surgery
Ultrasounds
Keywords: Ultrasounds
diaphragmatic function
thoracic surgery
regional anesthesia
Lead sponsor: University of Turin, Italy
Sponsor class: OTHER
First posted: 2021-01-08
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients scheduled for lung biopsy were enrolled prospectively starting from February 2019 to September 2020.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Diaphragmatic maximal function
timeFrame: 12 hours
Secondary outcomes:
measure: Pain scores
timeFrame: 24 hours
measure: Postoperative Nausea and Vomiting
timeFrame: 24 hours
Other outcomes:
Locations:
city: Turin
country: Italy
facility: AOU Città della Salute e della Scienza di Torino
Study officials:
affiliation: University of Torino
name: Luca Brazzi, Professor
role: STUDY_CHAIR
References: