Ultrasound Assessment of Diaphragmatic Dysfunction in Regional Anesthesia

NCT04700943 | Completed

• 1 other identifier: DULORATHO
• Study Type: observational
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Regional Anesthesia; Diaphragm Issues; Thoracic Surgery; Ultrasounds

Keywords

Ultrasounds; diaphragmatic function; thoracic surgery; regional anesthesia

Outcome Measures

Primary Outcomes (1)

• Diaphragmatic maximal function

  Measured with diaphragmatic excursion

  12 hours

Secondary Outcomes (2)

• Pain scores

  24 hours

• Postoperative Nausea and Vomiting

  24 hours

Study Arms (2)

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.

Procedure: Regional awake anesthesia

General anesthesia

Either epidural block or an interfascial plane block of the thoracic wall, such as serratus anterior plane block or erector spinae plane block, were performed. Patients were then anesthetized with Propofol plus opiates (usually remifentanil) and muscle paralysis was achieved with Rocuronium.

Interventions

Regional awake anesthesia PROCEDURE

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

Regional awake anesthesia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients scheduled for lung biopsy were enrolled prospectively starting from February 2019 to September 2020.

You may qualify if:

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

You may not qualify if:

• pregnancy,
• Body Mass Index \>35,
• Inability to provide informed consent,
• American Society of Anesthesiologists physical status classification score of IV
• Recommended postoperative ICU care

Sponsors & Collaborators

• University of Turin, Italy: lead

Study Sites (1)

AOU Città della Salute e della Scienza di Torino

Turin, 10100, Italy

Location

Study Officials

• Luca Brazzi, Professor

  University of Torino

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2021
• First Posted: January 8, 2021
• Study Start: February 1, 2019
• Primary Completion: September 30, 2020
• Study Completion: January 1, 2021
• Last Updated: January 11, 2021

Record last verified: 2021-01

Locations

IT (1)