Brief Summary

The TEMA study (Targeting prEssure-Muscle-index to avoid ventilatory over-Assistance during pressure support ventilation) is a prospective, interventional crossover trial investigating the relationship between pressure support (PS) and tidal volume (Vt) in ICU patients with acute hypoxemic respiratory failure (AHRF) receiving pressure support ventilation (PSV). The study aims to assess whether the Pressure-Muscle Index (PMI)-a marker derived from the difference between plateau and peak inspiratory pressure-can help identify the optimal level of ventilatory assistance, preventing over-assistance and its associated complications such as diaphragm atrophy and patient self-inflicted lung injury (P-SILI). By exploring the sigmoidal relationship between PS and Vt, the study seeks to define a physiological threshold (PMI=0) that may serve as a personalized target for PSV titration.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P25-P50 for not_applicable

Timeline

11mo left

Started Oct 2025

Geographic Reach

1 country

1 active site

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

1.5 years study duration

Study Progress39%

Oct 2025Apr 2027

First Submitted

Initial submission to the registry

March 11, 2025

Completed

1 month until next milestone

First Posted

Study publicly available on registry

April 10, 2025

Completed

6 months until next milestone

Study Start

First participant enrolled

October 8, 2025

Completed

1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 8, 2027

Expected

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 8, 2027

Last Updated

February 3, 2026

Status Verified

January 1, 2026

Enrollment Period

1.5 years

First QC Date

March 11, 2025

Last Update Submit

January 30, 2026

Conditions

Mechanical Ventilation Complication Acute Hypoxemic Respiratory Failure

Keywords

Pressure SupportTidal VolumeAcute Hypoxemic Respiratory Failure

Outcome Measures

Primary Outcomes (1)

Pressure Support-Tidal Volume (PS-Vt) Relationship
The primary aim is to determine whether the PS-Vt curve exhibits a flat region (where tidal volume remains stable) before transitioning into a steep, compliance-dependent increase at higher PS levels. This transition point, identified as PSPMI=0, is hypothesized to represent the threshold for over-assistance.
Up to 5 minutes after each PS level adjustment during the interventional phase (Day 1)

Secondary Outcomes (11)

Validation of Pressure-Muscle Index (PMI) as an Over-Assistance Marker
Up to 5 minutes after each PS level adjustment during the interventional phase (Day 1) and during follow-up assessment on Days 4-6 (if patient remains intubated)
Impact of Respiratory Mechanics on PS-Vt Relationship
During the interventional phase on Day 1 and during follow-up assessment on Days 4-6 (if patient remains intubated)
Rate of Ineffective Efforts During Over-Assistance
Up to 5 minutes after each PS level adjustment during the interventional phase (Day 1) and during follow-up assessment on Days 4-6 (if patient remains intubated)
Effect of Over-Assistance on Ventilatory Asynchronies
Up to 5 minutes after each PS level adjustment during the interventional phase (Day 1) and during follow-up assessment on Days 4-6 (if patient remains intubated)
Weaning failure
Up to 100 months or until the of death from any cause, whichever came first.
+6 more secondary outcomes

Study Arms (7)

Pressure Support PMI=0

EXPERIMENTAL

The PS level at which PMI is zeroed, meaning the patient's inspiratory effort contributes minimally to tidal volume