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出境医 / 临床实验 / Phrenic Nerve Block to Mitigate Self-inflicted Lung Injury

Phrenic Nerve Block to Mitigate Self-inflicted Lung Injury

Study Description
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.

Condition or disease Intervention/treatment Phase
Respiratory Failure Mechanical Ventilation Drug: Lidocaine Not Applicable

Detailed Description:

The use of protective mechanical ventilation has improved prognosis on patients with Acute Respiratory Failure. The association of neuromuscular blockade in the first 48-72h has additionally contributed to a higher survival rate. Such improvement may be due to the reduction of transpulmonary pressures caused by the patient's inspiratory effort. To achieve appropriate neuromuscular blockade, highes doses of both neuromuscular blocking agents and sedatives are required. Therefore, such a strategy usually causes muscular atrophy, including the diaphragm.

Because of the augmented neural drive of such patients, exacerbated by inflammation and pulmonary edema, the consequent high tidal volume and transpulmonary pressure cannot be reduced by the newest sedatives. In fact, some of these sedatives may even deteriorate ventilatory dyssynchrony. Our intention is to verify a novel approach: whether is possible to reduce the inspiratory effort of patients without the use of systemic neuromuscular blocking agents.

Our objective in this proof of concept study is to determine the feasibility the use of phrenic nerve blockade to decrease transpulmonary pressure and tidal volume, as well as quantify its effects on esophageal pressure, diaphragmatic electrical activity, transpulmonary pressure and ventilation distribution in patients on spontaneous breathing. It is expected that such intervention will reduce diaphragm electrical activity, leading to lower transpulmonary pressure, tidal volume and driving pressures.

All patients will be submitted to the same intervention. Respiratory mechanics, ventilation distribution, diaphragm electrical activity, heart rate, mean arterial pressure and peripheral saturation will be collected throughout the study. Once the patient presents the same diaphragmatic electrical activity and transpulmonary pressure as before the phrenic nerve block, the study will be over.

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: All patients will be submitted to the same procedures. There will be no between-group comparisons.
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Feasibility of Phrenic Nerve Block to Mitigate Self-inflicted Lung Injury in ARF Patients Under Mechanical Ventilation on Spontaneous Breathing
Actual Study Start Date : May 15, 2019
Actual Primary Completion Date : December 31, 2019
Actual Study Completion Date : September 9, 2020
Arms and Interventions
Arm Intervention/treatment
Experimental: Phrenic Nerve Blockade
All patients will be submitted to bilateral phrenic nerve block on its cervical portion.
 Drug: Lidocaine
Using an ultrasound and a nerve stimulator, the phrenic nerve will be identified and low-dose lidocaine will be administered perineurally.
Other Name: Local anesthetic
Outcome Measures
Primary Outcome Measures :
  1. Reduction of tidal volume or transpulmonary pressure [ Time Frame: 20 minutes ]
    Tidal volume or transpulmonary pressure measured using EIT, Servo-I and an esophageal balloon


Secondary Outcome Measures :
  1. Reduction of the inspiratory effort [ Time Frame: 20 minutes - 3 hours ]
    Diaphragm electrical activity using NAVA

  2. Consequences on mechanical ventilation [ Time Frame: 20 minutes - 3 hours ]
    Tidal volume, pendellfut and asynchronies measured by EIT

  3. Time to complete weaning of the blockade [ Time Frame: 30 minutes - 3 hours ]
    Patients will be monitored until full recover of inspiratory effort or diaphragm electrical activity

  4. Reduction of the inspiratory effort [ Time Frame: 20 minutes - 3 hours ]
    Esophageal pressure using an esophageal catheter


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.
Contacts and Locations

Locations
Layout table for location information
Brazil
Hospital das Clínicas - Faculdade de Medicina da Universidade de Sao Paulo
São Paulo, Brazil, 01246-903
Sponsors and Collaborators
University of Sao Paulo General Hospital
Investigators
Layout table for investigator information
Principal Investigator: 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
Tracking Information
First Submitted Date  ICMJE May 10, 2019
First Posted Date  ICMJE June 7, 2019
Last Update Posted Date September 30, 2020
Actual Study Start Date  ICMJE May 15, 2019
Actual Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 5, 2019) 		Reduction of tidal volume or transpulmonary pressure [ Time Frame: 20 minutes ]
Tidal volume or transpulmonary pressure measured using EIT, Servo-I and an esophageal balloon
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 5, 2019)
  • Reduction of the inspiratory effort [ Time Frame: 20 minutes - 3 hours ]
    Diaphragm electrical activity using NAVA
  • Consequences on mechanical ventilation [ Time Frame: 20 minutes - 3 hours ]
    Tidal volume, pendellfut and asynchronies measured by EIT
  • Time to complete weaning of the blockade [ Time Frame: 30 minutes - 3 hours ]
    Patients will be monitored until full recover of inspiratory effort or diaphragm electrical activity
  • Reduction of the inspiratory effort [ Time Frame: 20 minutes - 3 hours ]
    Esophageal pressure using an esophageal catheter
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phrenic Nerve Block to Mitigate Self-inflicted Lung Injury
Official Title  ICMJE Feasibility of Phrenic Nerve Block to Mitigate Self-inflicted Lung Injury in ARF Patients Under Mechanical Ventilation on Spontaneous Breathing
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.
Detailed Description

The use of protective mechanical ventilation has improved prognosis on patients with Acute Respiratory Failure. The association of neuromuscular blockade in the first 48-72h has additionally contributed to a higher survival rate. Such improvement may be due to the reduction of transpulmonary pressures caused by the patient's inspiratory effort. To achieve appropriate neuromuscular blockade, highes doses of both neuromuscular blocking agents and sedatives are required. Therefore, such a strategy usually causes muscular atrophy, including the diaphragm.

Because of the augmented neural drive of such patients, exacerbated by inflammation and pulmonary edema, the consequent high tidal volume and transpulmonary pressure cannot be reduced by the newest sedatives. In fact, some of these sedatives may even deteriorate ventilatory dyssynchrony. Our intention is to verify a novel approach: whether is possible to reduce the inspiratory effort of patients without the use of systemic neuromuscular blocking agents.

Our objective in this proof of concept study is to determine the feasibility the use of phrenic nerve blockade to decrease transpulmonary pressure and tidal volume, as well as quantify its effects on esophageal pressure, diaphragmatic electrical activity, transpulmonary pressure and ventilation distribution in patients on spontaneous breathing. It is expected that such intervention will reduce diaphragm electrical activity, leading to lower transpulmonary pressure, tidal volume and driving pressures.

All patients will be submitted to the same intervention. Respiratory mechanics, ventilation distribution, diaphragm electrical activity, heart rate, mean arterial pressure and peripheral saturation will be collected throughout the study. Once the patient presents the same diaphragmatic electrical activity and transpulmonary pressure as before the phrenic nerve block, the study will be over.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
All patients will be submitted to the same procedures. There will be no between-group comparisons.
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Respiratory Failure
  • Mechanical Ventilation
Intervention  ICMJE Drug: Lidocaine
Using an ultrasound and a nerve stimulator, the phrenic nerve will be identified and low-dose lidocaine will be administered perineurally.
Other Name: Local anesthetic
Study Arms  ICMJE Experimental: Phrenic Nerve Blockade
All patients will be submitted to bilateral phrenic nerve block on its cervical portion.
Intervention: Drug: Lidocaine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 5, 2019) 		10
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 9, 2020
Actual Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03978845
Other Study ID Numbers  ICMJE CAAE 02029118.2.0000.00.68
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of Sao Paulo General Hospital
Study Sponsor  ICMJE University of Sao Paulo General Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: 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
PRS Account University of Sao Paulo General Hospital
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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