diaphragm protective ventilation

Preserving the Strength to Breathe: A Randomized Trial of Diaphragm-Protective Ventilation in Sepsis

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

PACTR

Registry ID

PACTR202606632263167

Enrollment

112

Registered

2026-06-18

Start date

2026-05-31

Completion date

Unknown

Last updated

2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory

Interventions

Standard Ventilation

Diaphragm Protective Ventilation

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Age = 18 years. Diagnosis of sepsis or septic shock according to Sepsis-3 criteria. Expected to require invasive mechanical ventilation for = 48 hours. Intubated within the previous 24 hours. Written informed consent from the patient or legally authorized representative.

Exclusion criteria

Exclusion criteria: 1. Pre-existing neuromuscular disorders affecting the diaphragm (e.g., myasthenia gravis, ALS, known diaphragmatic paralysis). Severe ongoing hemodynamic instability (norepinephrine > 0.3 µg·kg?¹·min?¹ or equivalent) making ventilator changes unsafe. Pregnancy. Major thoracic trauma or spinal cord injury expected to affect respiratory mechanics or diaphragm function. Active, untreated air leak (large bronchopleural fistula, untreated pneumothorax) or significant chest wall deformity that precludes reliable ultrasound. Anticipated withdrawal of life-sustaining therapy or expected death within 24 hours.

Design outcomes

Primary

Measure	Time frame
The number of ventilator-free days at 28 days (VFD-28) in patients with sepsis requiring invasive mechanical ventilation after diaphragm-protective ventilation strategy.	—

Secondary

Measure	Time frame
Time to first successful spontaneous breathing trial (SBT). Duration of invasive mechanical ventilation (from intubation to final extubation). Extubation success at 48 hours (defined as absence of reintubation or invasive/non-invasive ventilatory support within 48 hours post-extubation). Need for tracheostomy (cumulative incidence at day 28). ;• Daily diaphragm thickening fraction (DTF) during the intervention period. • Daily P0.1 during the intervention period. • Trajectories of DTF and P0.1 over time (area under the curve). • Development of ventilator-induced diaphragm dysfunction (VIDD), defined as DTF 1 min) or severe tachypnea (RR > 40/min) directly related to protocolized ventilator adjustments. • Hemodynamic instability requiring immediate reversal of ventilator changes. • Any serious adverse event (SAE) attributable to the intervention. ;all cause mortality	—

Measure

Time frame

Time to first successful spontaneous breathing trial (SBT). Duration of invasive mechanical ventilation (from intubation to final extubation). Extubation success at 48 hours (defined as absence of reintubation or invasive/non-invasive ventilatory support within 48 hours post-extubation). Need for tracheostomy (cumulative incidence at day 28). ;• Daily diaphragm thickening fraction (DTF) during the intervention period. • Daily P0.1 during the intervention period. • Trajectories of DTF and P0.1 over time (area under the curve). • Development of ventilator-induced diaphragm dysfunction (VIDD), defined as DTF 1 min) or severe tachypnea (RR > 40/min) directly related to protocolized ventilator adjustments. • Hemodynamic instability requiring immediate reversal of ventilator changes. • Any serious adverse event (SAE) attributable to the intervention. ;all cause mortality

—

Countries

Egypt

Contacts

Public Contactkhaled gaballah

assistant professor of anesthesia and critical care

khgaballah@gmail.com00201016009073

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026