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Phrenic Nerve Block to Mitigate Self-inflicted Lung Injury

NCT03978845 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2020-09-30

No results posted yet for this study

Summary

The purpose of this single-centered, proof of concept study is to determine whether it is feasible to perform a phrenic nerve block to reduce diaphragm electrical activity and, therefore, inspiratory effort and if such block reduces self-inflicted lung injury on patients under mechanical ventilation on spontaneous breathing. Ten patients will be monitored with electrical impedance tomography, NAVA catheter, and esophageal balloon. Using a nerve stimulator and an ultrasound, we will identify the phrenic nerve on its cervical portion bilaterally and administer perineural low-dose lidocaine. Diaphragm electrical activity, transpulmonary pressure and data on ventilation distribution will be continuously collected. The study will be over once the patient presents the same diaphragm electrical activity and transpulmonary pressure as before the phrenic nerve block.

Conditions

Interventions

DRUG

Lidocaine

Using an ultrasound and a nerve stimulator, the phrenic nerve will be identified and low-dose lidocaine will be administered perineurally.

Sponsors & Collaborators

  • University of Sao Paulo General Hospital

    lead OTHER

Principal Investigators

  • Joaquim E Vieira, MD, PhD · University of Sao Paulo School of Medicine

  • Marcelo BP Amato, MD, PhD · University of Sao Paulo School of Medicine

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-15
Primary Completion
2019-12-31
Completion
2020-09-09

Countries

  • Brazil

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03978845 on ClinicalTrials.gov