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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Respiratory Failure
• Intervention / Treatment: Diagnostic test: Nasal pressure assessment

• Study Type: Observational
• Enrollment (Estimated): 175

Contacts and Locations

• Study Contact: Name: Alessandro Marchioni, MD; Phone Number: +390594225859; Email: marchioni.alessandro@unimore.it
• Study Contact Backup: Name: Roberto Tonelli, MD; Phone Number: +390594225934; Email: roberto.tonelli@me.com

Study Locations

• Italy
  • Modena, Italy
    • Azienda Ospedaliero Universitaria Policlinico di Modena

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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

Description

Inclusion Criteria:

- candidates for endotracheal tube removal.

Exclusion Criteria:

• 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)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weaning failure	Weaning failure will be defined by need for re-intubation	48 hours

Collaborators and Investigators

• Sponsor: University of Modena and Reggio Emilia

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2027
• Primary Completion (Estimated): May 1, 2030
• Study Completion (Estimated): December 31, 2033

Study Registration Dates

• First Submitted: March 7, 2022
• First Submitted That Met QC Criteria: March 7, 2022
• First Posted (Actual): March 16, 2022

Study Record Updates

• Last Update Posted (Actual): April 25, 2025
• Last Update Submitted That Met QC Criteria: April 24, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Weaning Failure; Inspiratory Effort; Nasal Pressure
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency; Respiratory Aspiration
• Other Study ID Numbers: UModenaReggio15

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No