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Prediction of Response to Recruitment Maneuvers in Patients With Acute Respiratory Failure

Prediction of Response to Recruitment Maneuvers in Patients With Acute Respiratory Failure

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02907840
Enrollment
14
Registered
2016-09-20
Start date
2016-04-30
Completion date
2017-05-31
Last updated
2017-05-08

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

Conditions

Acute Respiratory Failure

Brief summary

The study will explore the possibility to predict potential for recruitment in acute hypoxemic respiratory failure patients by electrical impedance tomography (EIT) Swisstom BB2 (Swisstom, Landquart, Switzerland) during stepwise increase in positive end-expiratory pressure (PEEP) followed by recruitment maneuver (RM). It will compare data obtained by EIT to those obtained by pressure-volume (P-V) curves on respiratory system mechanics and data on pulmonary gas exchange.

Detailed description

The investigators will monitor lung ventilation by EIT during the whole protocol and perform P-V curves and arterial blood gas analysis at every step of the protocol. Participants will be sedated and paralyzed, ventilated in volume-controlled with protective ventilation (tidal volume=6-8 mL/Kg of predicted body weight and respiratory rate set to obtain normal pH) then the protocol will follow 5 steps each lasting 20 minutes to obtain clinical stability: 1. PEEP 5 centimeter of water (cmH2O) 2. PEEP 10 cmH2O 3. Recruitment maneuver followed by PEEP 15 cmH2O 4. PEEP 10 cmH2O 5. PEEP 5 cmH2O

Interventions

DEVICESwisstom BB2

Electrical impedance tomography lung monitoring uses a dedicated belt placed around patient's thorax to detect change in impedance due to change in aeration within the thorax

Sponsors

Università degli Studi di Ferrara
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients with acute hypoxemic respiratory failure defined by recent known clinical insult or worsening of respiratory symptoms and arterial pressure of oxygen to inspired fraction of oxygen ratio (PaO2/FiO2) ≤300 mmHg * Patient on invasive mechanical ventilation * Age ≥18 years * Written informed consent

Exclusion criteria

* Pregnancy * Unstable hemodynamic condition requiring blood transfusion or adjustment of inotropics more often than every hour * FiO2 ≥80% or clinical suspicion of pulmonary embolism * Pneumothorax * Chronic obstructive pulmonary disease (COPD) with clinical symptoms of lung emphysema as evidenced by chest radiography or computed tomography or autoPEEP \> 5 cmH2O * Intracranial hypertension * Impossibility to correctly position the EIT belt (e.g., dressings, chest drainage, etc.) * Contraindications to EIT (e.g., implantable cardiac defibrillator, pacemaker, instable spinal lesions)

Design outcomes

Primary

MeasureTime frame
Significant reduction in silent spaces (i.e. non ventilated lung areas) during incremental PEEP stepsWithin 20 minutes from PEEP increase

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026