Phrenic Nerve Block to Mitigate Self-inflicted Lung Injury

Respiratory Failure Clinical Trial

Official title:

Feasibility of Phrenic Nerve Block to Mitigate Self-inflicted Lung Injury in ARF Patients Under Mechanical Ventilation on Spontaneous Breathing

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03978845
• Other study ID #: CAAE 02029118.2.0000.00.68
• Status: Completed
• Phase: N/A
• Start date: May 15, 2019
• Est. completion date: September 9, 2020

Study information

• Verified date: May 2019
• Source: University of Sao Paulo General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: September 9, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lung Injury
• Mechanical Ventilation
• Respiratory Failure
• Respiratory Insufficiency

Intervention

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

Locations

Country	Name	City	State
Brazil	Hospital das Clínicas - Faculdade de Medicina da Universidade de Sao Paulo	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of tidal volume or transpulmonary pressure	Tidal volume or transpulmonary pressure measured using EIT, Servo-I and an esophageal balloon	20 minutes
Secondary	Reduction of the inspiratory effort	Diaphragm electrical activity using NAVA	20 minutes - 3 hours
Secondary	Consequences on mechanical ventilation	Tidal volume, pendellfut and asynchronies measured by EIT	20 minutes - 3 hours
Secondary	Time to complete weaning of the blockade	Patients will be monitored until full recover of inspiratory effort or diaphragm electrical activity	30 minutes - 3 hours
Secondary	Reduction of the inspiratory effort	Esophageal pressure using an esophageal catheter	20 minutes - 3 hours