Advanced Respiratory Monitoring for Safer Mechanical Ventilation in Patients Without Respiratory Failure (ADAPT)

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.

Study Overview

• Status: Recruiting
• Conditions: Developing Acute Respiratory Distress Syndrome
• Intervention / Treatment: Diagnostic test: Advanced Non-Invasive Respiratory Monitoring

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 40

Contacts and Locations

Study Locations

• Italy
  • Lombardy
    • Milan, Lombardy, Italy, 20089
      • Recruiting
      • Humanitas Research Hospital
      • Contact: Giulia Lionetti GL Medical Doctor and Anesthesiologist, Medicine and Anesthesiology; Phone Number: 0282243789; Email: giulia.lionetti@humanitas.it
      • Contact: Alessandro Santini AS Medical Doctor and Anesthesiologist, Medicine and Anesthesiology; Phone Number: 0282243789; Email: alessandri.santini@humanitas.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population consists of adult patients admitted to the Intensive Care Unit (ICU) who require invasive mechanical ventilation for reasons entirely distinct from acute respiratory failure, such as coma, trauma, or sepsis. Eligible individuals must be enrolled and have monitoring initiated within the first 24 hours of oro-tracheal intubation. The cohort excludes patients with specific barotrauma complications, pregnant individuals, and those with absolute clinical contraindications to the required monitoring procedures.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Adult patients without acute respiratory failure undergoing mechanical ventilation.

Diagnostic test: Advanced Non-Invasive Respiratory Monitoring; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Acute Respiratory Distress Syndrome (ARDS)	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.	Within the first 7 days of Intensive Care Unit (ICU) admission.

Collaborators and Investigators

• Sponsor: Istituto Clinico Humanitas

Study record dates

Study Major Dates

• Study Start (Estimated): June 30, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026

Study Registration Dates

• First Submitted: June 30, 2026
• First Submitted That Met QC Criteria: June 30, 2026
• First Posted (Actual): July 7, 2026

Study Record Updates

• Last Update Posted (Actual): July 7, 2026
• Last Update Submitted That Met QC Criteria: June 30, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: ARDS
• Other Study ID Numbers: ADAPT

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