Ultrasound Assessment of Diaphragmatic Dysfunction in Regional Anesthesia

Sponsor
University of Turin, Italy (Other)
Overall Status
Completed
CT.gov ID
NCT04700943
Collaborator
(none)
41
1
23
1.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Regional awake anesthesia

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 Design

Study Type:
Observational
Actual Enrollment :
41 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Ultrasound Assessment of Diaphragmatic Dysfunction: General Versus Regional Anesthesia for Video-assisted Thoracoscopic Surgery Pulmonary Biopsy in Interstitial Lung Disease
Actual Study Start Date :
Feb 1, 2019
Actual Primary Completion Date :
Sep 30, 2020
Actual Study Completion Date :
Jan 1, 2021

Arms and Interventions

Arm Intervention/Treatment
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
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

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.

Outcome Measures

Primary Outcome Measures

  1. Diaphragmatic maximal function [12 hours]

    Measured with diaphragmatic excursion

Secondary Outcome Measures

  1. Pain scores [24 hours]

    Numeric rate scale

  2. Postoperative Nausea and Vomiting [24 hours]

    Presence/absence of Postoperative Nausea and Vomiting

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 AOU Città della Salute e della Scienza di Torino Turin Italy 10100

Sponsors and Collaborators

  • University of Turin, Italy

Investigators

  • Study Chair: Luca Brazzi, Professor, University of Torino

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Turin, Italy
ClinicalTrials.gov Identifier:
NCT04700943
Other Study ID Numbers:
  • DULORATHO
First Posted:
Jan 8, 2021
Last Update Posted:
Jan 11, 2021
Last Verified:
Jan 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University of Turin, Italy
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 11, 2021