Ultrasound Assessment of Diaphragmatic Dysfunction in Regional Anesthesia
- Conditions
- Diaphragm IssuesThoracic SurgeryUltrasoundsRegional Anesthesia
- Interventions
- Procedure: Regional awake 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 41
- Patients scheduled for lung biopsy from February 2019 to September 2020
- 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
- Arm && Interventions
Group Intervention Description Regional awake anesthesia Regional awake anesthesia In non-intubated patients, an epidural catheter was placed at T5-T6. An anesthetic load of 0,5 mg/kg of ropivacaine was administered to reach anesthesia of the thoracic wall. Adjunctive local anesthetic infiltration of the incision site was performed by the surgeon with 2% lidocaine and 7,5% Ropivacaine. The cumulative dose of anesthetics drugs was computed as not to exceed the recommended dosage. To improve patient comfort through the procedure, sedation with Target Controlled Infusion of propofol (using Schnider algorithm) and low dose remifentanil (0,05 mcg/kg/min) was also administered.
- Primary Outcome Measures
Name Time Method Diaphragmatic maximal function 12 hours Measured with diaphragmatic excursion
- Secondary Outcome Measures
Name Time Method Pain scores 24 hours Numeric rate scale
Postoperative Nausea and Vomiting 24 hours Presence/absence of Postoperative Nausea and Vomiting
Trial Locations
- Locations (1)
AOU Città della Salute e della Scienza di Torino
🇮🇹Turin, Italy