Respiratory FailureNAIVENCT05282238
Quantification of Inspiratory Effort Through Nasal Pressure in Patients Undergoing Weaning From Invasive Mechanical Ventilation and Correlation With Clinical Outcomes
An observational study of Respiratory Failure, run by University of Modena and Reggio Emilia at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Failure
- What is being tested?
- Nasal pressure assessment
- How many people
- 175 participants
- Where
- 1 siteItaly
- Study dates
- 1 May 2027to 31 Dec 2033
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- candidates for endotracheal tube removal.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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
- Being tested
- Nasal pressure assessment
- Keywords
- Weaning Failure, Inspiratory Effort, Nasal Pressure
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasal pressure assessmentDiagnostic 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Weaning failure
Weaning failure will be defined by need for re-intubation
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2022
- Study start1 May 2027 (estimated)
- Primary completion1 May 2030 (estimated)
- Study completion31 Dec 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 175 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Modena and Reggio Emilia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roberto Tonelli, University of Modena and Reggio Emilia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05282238
- Sponsor's protocol ID
- UModenaReggio15
- Acronym
- NAIVE
- Status last verified
- Apr 2025
- First submitted
- 7 Mar 2022
- Last updated
- 25 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No