Neural Pressure Support and Non-invasive Estimation of Transpulmonary Pressure in Spontaneous Ventilation Modes

NCT ID: NCT05574829

Last Updated: 2022-10-13

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 26 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-05-20
• Study Completion Date: 2023-03-31

Brief Summary

The transition from controlled mechanical ventilation to assisted ventilation is one of the most complex and compromised phases of the ventilatory management during mechanical ventilation, affected by factors such as:

• Asynchronies, due to patient-respirator dis-synchrony in ins- and expiratory neural and mechanical times, as well as inadequate levels of assistance.
• Risks of self-induced lung injury resulting from uncontrolled increases in transpulmonary pressure when high inspiratory efforts are combined with inappropriate levels of inspiratory pressure assistance.

Current monitoring of assisted ventilation is complex and not well resolved by most conventional ventilators. Asynchronies are difficult to monitor with the pressure or flow/time curves present in conventional ventilators requiring an advanced level of expertise. Measurements of the patient's muscular effort and therefore of transpulmonary pressure, requires the use of esophageal manometry with cumbersome handling and interpretation.

NAVA (Neurally Adjusted Ventilatory Assist) is a ventilator mode that uses electrical activity of the diaphragm (EAdi), monitored via a modified nasogastric feeding catheter, to control and assist the respiratory cycle by the ventilator. Recently, a "hybrid" mode between the conventional pressure support assisted mode (PSV) and NAVA called Neural-Pressure Support Ventilation (N-PSV) has been developed. This mode uses a neural trigger based on the EAdi to match the patient's and ventilator's in- and expiratory time, but unlike NAVA, assisting in the same way as in pressure support. In addition the EAdi allows to assess the extent to which the patient's muscle strength contributes to the patient-ventilator breath (PVBC), and it has recently been suggested that on the basis of PVBC it may also be possible to directly estimate the patient's transpulmonary pressure (PL).

Hypothesis:

1. EAdi allows direct estimation of PL during the assisted ventilation phase without the need of an oesophageal pressure balloon.

2. N-PSV can provide advantages over PSV by better matching ventilator and patient respiratory cycle times, thus reducing the risk of asynchronies.

Detailed Description

Consenting participants will be simultaneously monitored with a 8French EAdi catheter (to measure the electrical activity of the diaphragm) and a 15French nasogastric catheter with an oesophageal balloon to measure oesophageal manometry during the 120 min of the total study period.

After confirming correct positioning and measurement of both catheters participants will be submitted to the following protocol:

Baseline ventilation in pressure support ventilation during 30 min Baseline ventilation in neural-pressure support ventilation during 30 min Under-assistance in neural pressure support ventilation reducing the baseline level of pressure support by 50% (with a minimum of 5 cmH2O) during 30 min Over-assistance in neural pressure support ventilation by increasing the baseline level of pressure by 50% during 30 min.

The sequence of the last two steps will be randomly determined. After completing the protocol the EAdi catheter will be removed.

Conditions

Mechanical Ventilation Complication

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients under pressure support ventilation

Patients under assisted mechanical ventilation monitored with esophageal manometry and electrical activity of the diaphragm

Esophageal manometry and monitoring of electrical activity of the diaphragm

Intervention Type: DEVICE

Esophageal manometry and monitoring of electrical activity of the diaphragm

Interventions

Esophageal manometry and monitoring of electrical activity of the diaphragm

Esophageal manometry and monitoring of electrical activity of the diaphragm

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Age > 18 years
• Mechanically assisted ventilation
• Patients with a nasogastric catheter
• Obtained informed consent
• Clinical stability, defined as:

• Low ventilatory support requirement: FiO2 (Fraction of inspired oxygen) ≤ 0.5; PEEP (positive end-expiratory pressure) ≤ 10 cmH2O (up to 12 cmH2O for patients with a body mass index ≥ 30 kg/m2).
• Haemodynamic stability: a)low vasopressor requirement: Noradrenaline ≤ 0.2 microg/kg/min; b)Mean blood pressure ≥ 60 mmHg; c)No new arrhythmias.

Exclusion Criteria

• Presence of Contraindications for the insertion of a nasogastric tube: oesophageal pathology. Coagulopathy, bleeding diathesis
• Clinical instability

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Maquet Critical Care

UNKNOWN

Sponsor Role: collaborator

Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hospital Universitario de La Princesa

Madrid, , Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Fernando Suarez Sipmann, MD

Role: CONTACT

fsuarezsipmann@gmail.com

+34 665052460

Marta Sanchez Galindo, MD

Role: CONTACT

martasangal_6@hotmail.com

+34 675203249

Facility Contacts

Fernando Suarez Sipmann, MD

Role: primary

fsuarezsipmann@gmail.com

+34 665052460

Marta Sanchez Galingo, MD

Role: backup

martasangal_6@hotmail.com

+34 675203249

Other Identifiers

EADITRAP

Identifier Type: -

Identifier Source: org_study_id