Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT05282238

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Azienda Ospedaliero Universitaria Policlinico di Modena

Modena, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

  1. Weaning failure

    Time frame: 48 hours

    Weaning failure will be defined by need for re-intubation

Study contacts

Contact information is provided by the study sponsor or research team.

Alessandro Marchioni, MD

CONTACT

[email protected]

+390594225859

Roberto Tonelli, MD

CONTACT

[email protected]

+390594225934

Sponsors and collaborators

Lead sponsor

University of Modena and Reggio Emilia

Other

Registry information

Acronym: NAIVE

Important dates

Study start
2027
Primary completion
2030
Study completion
2033
First posted
Mar 16, 2022
Registry last updated
Apr 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.