Phrenic Nerve Block to Mitigate Self-inflicted Lung Injury

NCT03978845 | Completed

• 1 other identifier: CAAE 02029118.2.0000.00.68
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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

Respiratory Failure; Mechanical Ventilation

Outcome Measures

Primary Outcomes (1)

• Reduction of tidal volume or transpulmonary pressure

  Tidal volume or transpulmonary pressure measured using EIT, Servo-I and an esophageal balloon

  20 minutes

Secondary Outcomes (4)

• Reduction of the inspiratory effort

  20 minutes - 3 hours

• Consequences on mechanical ventilation

  20 minutes - 3 hours

• Time to complete weaning of the blockade

  30 minutes - 3 hours

• Reduction of the inspiratory effort

  20 minutes - 3 hours

Study Arms (1)

Phrenic Nerve Blockade

EXPERIMENTAL

All patients will be submitted to bilateral phrenic nerve block on its cervical portion.

Drug: Lidocaine

Interventions

Lidocaine DRUG

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

Also known as: Local anesthetic

Phrenic Nerve Blockade

Eligibility Criteria

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

You may qualify if:

• Age \> 17 years-old;
• Under mechanical ventilation on spontaneous breathing, capable of triggering the ventilator with P/F \< 300;
• Tidal volume \> 10ml/kg with inspiratory pressure of 12 cmH2O OR driving pressure \> 15 cm H2O with inspiratory pressure of 12 cmH2O

You may not qualify if:

• Use of neuromuscular blocking agents less than 3h;
• Richmond Agitation-Sedation Scale (RASS) \> 0;
• Arterial pH \< 7.25;
• Hemodynamically unstable or with increasing doses of vasopressors in the last 2h;
• Intracranial hypertension;
• Thoracic or abdominal tubes;
• Any neuromuscular disease;
• Spinal injury;
• Ascitis;
• Thoracic burn injury;
• Tetanus;
• Pregnancy.

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

Hospital das Clínicas - Faculdade de Medicina da Universidade de Sao Paulo

São Paulo, 01246-903, Brazil

Location

MeSH Terms

Conditions

Respiratory Insufficiency

Interventions

Lidocaine; Anesthetics, Local

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses

Study Officials

• Joaquim E Vieira, MD, PhD

  University of Sao Paulo School of Medicine

  PRINCIPAL INVESTIGATOR

• Marcelo BP Amato, MD, PhD

  University of Sao Paulo School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All patients will be submitted to the same procedures. There will be no between-group comparisons.

Study Record Dates

• First Submitted: May 10, 2019
• First Posted: June 7, 2019
• Study Start: May 15, 2019
• Primary Completion: December 31, 2019
• Study Completion: September 9, 2020
• Last Updated: September 30, 2020

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)