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NCT Number: NCT07686315

Advanced Respiratory Monitoring for Safer Mechanical Ventilation in Patients Without Respiratory Failure

Patients admitted to the intensive care unit (ICU) and mechanically ventilated for reasons other than acute respiratory failure, such as coma, trauma, or sepsis, are at risk of developing acute respiratory distress syndrome (ARDS), which increases the duration of mechanical ventilation, mortality, and functional dependence at discharge.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Humanitas Research Hospital

Milan, Lombardy, 20089, Italy

Location status: Recruiting

Location contact

Alessandro Santini AS Medical Doctor and Anesthesiologist, Medicine and Anesthesiology

CONTACT

[email protected]

0282243789

Giulia Lionetti GL Medical Doctor and Anesthesiologist, Medicine and Anesthesiology

CONTACT

[email protected]

0282243789

About this study

Patients admitted to the intensive care unit (ICU) and mechanically ventilated for reasons other than acute respiratory failure, such as coma, trauma, or sepsis, are at risk of developing acute respiratory distress syndrome (ARDS), which increases the duration of mechanical ventilation, mortality, and functional dependence at discharge. Low tidal volume mechanical ventilation is recommended for these patients to prevent ARDS, but few other modifiable risk factors are known. Advanced respiratory monitoring, which includes continuous recording of airway and esophageal pressure, inspiratory and expiratory flow, and the distribution of ventilation within the lungs, has been used in patients with ARDS to personalize ventilation parameters, prevent ventilator-induced lung injury (VILI), and improve outcomes. It is unknown whether the use of these same monitoring techniques in patients without respiratory failure at the time of ICU admission can prevent the development of ARDS.

Who can participate

Healthy volunteers accepted: No

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

Study Population Eligibility Ages Eligible for Study: 18 Years and older (Adult, Older Adult) Sexes Eligible for Study: All Accepts Healthy Volunteers: No

Inclusion criteria

Adult patients +18 years. Undergoing invasive mechanical ventilation for reasons other than acute respiratory failure (such as coma, trauma, or sepsis).

Initiation of monitoring within 24 hours of oro-tracheal intubation.

Exclusion criteria

Evidence of pneumothorax, pneumomediastinum, or subcutaneous emphysema. Pregnancy. Absolute contraindications to nasogastric tube placement. Absolute contraindications to electrical impedance tomography (EIT) monitoring.

Treatment and study plan

Advanced Non-Invasive Respiratory Monitoring

Diagnostic Test

Continuous measurement and recording of airway pressure, esophageal pressure, inspiratory and expiratory flow, and electrical impedance tomography (EIT) data during the first 24 hours of mechanical ventilation. A nasogastric tube equipped with an esophageal balloon is placed alongside an EIT electrode belt. Monitoring is performed continuously off-line without altering standard clinical management. Residual respiratory function is also evaluated via spirometry and EIT prior to Intensive Care Unit (ICU) discharge.

Primary outcomes

  1. Incidence of Acute Respiratory Distress Syndrome (ARDS)

    Time frame: Within the first 7 days of Intensive Care Unit (ICU) admission.

    Association between ARDS development and advanced respiratory monitoring parameters derived from:

    Airway pressure/flow analysis: tidal volume/kg of ideal body weight, respiratory rate, plateau pressure, driving pressure, respiratory system compliance, and stress index.

    Esophageal pressure analysis: lung compliance, transpulmonary plateau pressure, transpulmonary driving pressure, and chest wall compliance.

    Electrical impedance tomography (EIT): regional compliance and tidal volume distribution homogeneity.

Sponsors and collaborators

Lead sponsor

Istituto Clinico Humanitas

Other

Registry information

Acronym: ADAPT

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 7, 2026
Registry last updated
Jul 7, 2026

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.