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

NCT05574829 | Unknown

• 1 other identifier: EADITRAP
• Study Type: observational
• Target: 26
• Locations: 1 country
• Sites: 1

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:
• EAdi allows direct estimation of PL during the assisted ventilation phase without the need of an oesophageal pressure balloon.
• N-PSV can provide advantages over PSV by better matching ventilator and patient respiratory cycle times, thus reducing the risk of asynchronies.

Conditions

Mechanical Ventilation Complication

Outcome Measures

Primary Outcomes (2)

• Number of asynchronies

  Asynchrony index

  60 minutes

• Estimation of transpulmonary pressure

  Evaluation of a new method for measuring transpulmonary pressure based on the electrical activity of the diaphragm

  90 minutes

Study Arms (1)

Patients under pressure support ventilation

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

Device: Esophageal manometry and monitoring of electrical activity of the diaphragm

Interventions

Esophageal manometry and monitoring of electrical activity of the diaphragm DEVICE

Esophageal manometry and monitoring of electrical activity of the diaphragm

Patients under pressure support ventilation

Eligibility Criteria

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

Study Population

Adult patients under assisted mechanical ventilation with spontaneous breathing and adequate respiratory drive.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Fundación de Investigación Biomédica - Hospital Universitario de La Princesa: lead
• Maquet Critical Care: collaborator

Study Sites (1)

Hospital Universitario de La Princesa

Madrid, 28006, Spain

RECRUITING

Central Study Contacts

Fernando Suarez Sipmann, MD

CONTACT

+34 665052460; fsuarezsipmann@gmail.com

Marta Sanchez Galindo, MD

CONTACT

+34 675203249; martasangal_6@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2022
• First Posted: October 12, 2022
• Study Start: May 20, 2022
• Primary Completion: March 31, 2023
• Study Completion: March 31, 2023
• Last Updated: October 13, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)