Quantification of Inspiratory Effort Through Nasal Pressure in Patients Undergoing Weaning From Invasive Mechanical Ventilation and Correlation With Clinical Outcomes

NCT05282238 | Not Yet Recruiting

• 1 other identifier: UModenaReggio15
• Study Type: observational
• Target: 175
• Locations: 1 country
• Sites: 1

Brief Summary

Weaning from invasive mechanical ventilation (MV) constitutes a fundamental procedure in intensive care, covering up to 50% of time spent on ventilation (1). Endotracheal tube (ETT) removal might be an important but delicate step in intensive care setting. Failure and subsequent need for re-intubation can occur in up to 20% of cases leading to a significant increase in mortality rates (24%), longer hospital stay and prolonged need for ventilation. Comorbidities such as obesity, COPD and cardiac related diseases might further increase this risk reaching up to 60% of failure in extubation. In this scenario, accurate predictors of weaning failure are far welcomed. The recurrence of respiratory failure after extubation might considerably raise rates of failure, probably due to increased work of breathing in patients after ETT removal. Most recent guidelines on the use of non-invasive ventilation (NIV) suggest using NIV after ETT removal in subjects with high risk of failure. NIV could contribute to reduce work of breathing hence preventing the onset of respiratory failure after extubation. Therefore, measuring inspiratory effort and its variation in weaned patients might help in identifying patients with significant risk of failing extubation. Esophageal pressure swings (DeltaPES) can be measured through a nasogastric tube with a pressure transducer located in the inferior part of the esophagus. DeltaPES is an extremely precise and accurate method to quantify inspiratory effort, however its use in daily clinical practice is limited due to the invasive nature of the maneuver, elevated costs and need for considerable clinical training of operators. Physiological studies have shown a correlation between nasal pressure measured at nostril entrance and esophageal pressure (which in turn is a measure of respiratory effort . Therefore, measuring nasal pressure could represent a method to quantify inspiratory effort non-invasively, proving to be useful in daily clinical practice.

Conditions

Respiratory Failure

Keywords

Weaning Failure; Inspiratory Effort; Nasal Pressure

Outcome Measures

Primary Outcomes (1)

• Weaning failure

  Weaning failure will be defined by need for re-intubation

  48 hours

Interventions

Nasal pressure assessment DIAGNOSTIC_TEST

Once the patient is enrolled nasal pressure will be measured through a dedicated pressure line located at the nostril entrance and connected to a dedicated pressure transducer (OptiVentTM, SIDAM, Mirandola, Italy). Measured nasal pressure will be the result of the variation between inspiratory and expiratory pressure (DeltaPnose). The measurement of DeltaPnose will be obtained considering the average of 3 values registered during 3 breath after at least 3 minutes of stable and constant respiratory pattern. Pnose values will be measured before extubation (T0) and 30 minutes (T1), 2 hours (T2), 4 hours (T3), 12 hours (T4) , 24 hours (T5) and 48 hours (T6) after extubation.

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

Eligible patients will be enrolled among patients admitted in Intensive Care Unit of Azienda Ospedaliero-Universitaria Policlinico di Modena undergoing endotracheal intubation and mechanical ventilation

You may qualify if:

• \- candidates for endotracheal tube removal.

You may not qualify if:

• Age under 18
• Pregnancy
• Patient unable or unwilling to sign informed consent
• Neuromuscular diseases
• Patient with compromised neurological state (Glasgow Coma Scale (GCS) under 14/15)

Sponsors & Collaborators

• University of Modena and Reggio Emilia: lead

Study Sites (1)

Azienda Ospedaliero Universitaria Policlinico di Modena

Modena, Italy

Location

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Central Study Contacts

Roberto Tonelli, MD

CONTACT

+390594225934; roberto.tonelli@me.com

Alessandro Marchioni, MD

CONTACT

+390594225859; marchioni.alessandro@unimore.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 7, 2022
• First Posted: March 16, 2022
• Study Start (Estimated): May 1, 2027
• Primary Completion (Estimated): May 1, 2030
• Study Completion (Estimated): December 31, 2033
• Last Updated: April 25, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)