Phrenic Nerve Block to Mitigate Self-inflicted Lung Injury
Primary Purpose
Respiratory Failure, Mechanical Ventilation
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Lidocaine
Sponsored by
About this trial
This is an interventional supportive care trial for Respiratory Failure
Eligibility 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.
Sites / Locations
- Hospital das Clínicas - Faculdade de Medicina da Universidade de Sao Paulo
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Phrenic Nerve Blockade
Arm Description
All patients will be submitted to bilateral phrenic nerve block on its cervical portion.
Outcomes
Primary Outcome Measures
Reduction of tidal volume or transpulmonary pressure
Tidal volume or transpulmonary pressure measured using EIT, Servo-I and an esophageal balloon
Secondary Outcome Measures
Reduction of the inspiratory effort
Diaphragm electrical activity using NAVA
Consequences on mechanical ventilation
Tidal volume, pendellfut and asynchronies measured by EIT
Time to complete weaning of the blockade
Patients will be monitored until full recover of inspiratory effort or diaphragm electrical activity
Reduction of the inspiratory effort
Esophageal pressure using an esophageal catheter
Full Information
NCT ID
NCT03978845
First Posted
May 10, 2019
Last Updated
September 28, 2020
Sponsor
University of Sao Paulo General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03978845
Brief Title
Phrenic Nerve Block to Mitigate Self-inflicted Lung Injury
Official Title
Feasibility of Phrenic Nerve Block to Mitigate Self-inflicted Lung Injury in ARF Patients Under Mechanical Ventilation on Spontaneous Breathing
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
May 15, 2019 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
September 9, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Sao Paulo General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Failure, Mechanical Ventilation
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
All patients will be submitted to the same procedures. There will be no between-group comparisons.
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Phrenic Nerve Blockade
Arm Type
Experimental
Arm Description
All patients will be submitted to bilateral phrenic nerve block on its cervical portion.
Intervention Type
Drug
Intervention Name(s)
Lidocaine
Other Intervention Name(s)
Local anesthetic
Intervention Description
Using an ultrasound and a nerve stimulator, the phrenic nerve will be identified and low-dose lidocaine will be administered perineurally.
Primary Outcome Measure Information:
Title
Reduction of tidal volume or transpulmonary pressure
Description
Tidal volume or transpulmonary pressure measured using EIT, Servo-I and an esophageal balloon
Time Frame
20 minutes
Secondary Outcome Measure Information:
Title
Reduction of the inspiratory effort
Description
Diaphragm electrical activity using NAVA
Time Frame
20 minutes - 3 hours
Title
Consequences on mechanical ventilation
Description
Tidal volume, pendellfut and asynchronies measured by EIT
Time Frame
20 minutes - 3 hours
Title
Time to complete weaning of the blockade
Description
Patients will be monitored until full recover of inspiratory effort or diaphragm electrical activity
Time Frame
30 minutes - 3 hours
Title
Reduction of the inspiratory effort
Description
Esophageal pressure using an esophageal catheter
Time Frame
20 minutes - 3 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joaquim E Vieira, MD, PhD
Organizational Affiliation
University of Sao Paulo School of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Marcelo BP Amato, MD, PhD
Organizational Affiliation
University of Sao Paulo School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital das Clínicas - Faculdade de Medicina da Universidade de Sao Paulo
City
São Paulo
ZIP/Postal Code
01246-903
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Phrenic Nerve Block to Mitigate Self-inflicted Lung Injury
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