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OpenTrials
Completed

NCT Number: NCT04700943

Ultrasound Assessment of Diaphragmatic Dysfunction in Regional Anesthesia

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

AOU Città della Salute e della Scienza di Torino

Turin, 10100, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Diaphragmatic maximal function

    Time frame: 12 hours

    Measured with diaphragmatic excursion

Secondary outcomes

  1. Pain scores

    Time frame: 24 hours

    Numeric rate scale

  2. Postoperative Nausea and Vomiting

    Time frame: 24 hours

    Presence/absence of Postoperative Nausea and Vomiting

Sponsors and collaborators

Lead sponsor

University of Turin, Italy

Other

Registry information

Official study title

Ultrasound Assessment of Diaphragmatic Dysfunction: General Versus Regional Anesthesia for Video-assisted Thoracoscopic Surgery Pulmonary Biopsy in Interstitial Lung Disease

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Jan 8, 2021
Registry last updated
Jan 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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