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

NCT02907840 | Completed

• 1 other identifier: 141285
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Respiratory Failure

Outcome Measures

Primary Outcomes (1)

• Significant reduction in silent spaces (i.e. non ventilated lung areas) during incremental PEEP steps

  Within 20 minutes from PEEP increase

Study Arms (1)

Recruitment

EXPERIMENTAL

Lung aeration monitored by Swisstom BB2 during PEEP steps and recruitment maneuver

Device: Swisstom BB2

Interventions

Swisstom BB2 DEVICE

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

Recruitment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Università degli Studi di Ferrara: lead

Study Sites (1)

Azienda Ospedaliero Universitaria Sant'Anna

Ferrara, 44121, Italy

Location

Related Publications (2)

• Scaramuzzo G, Spadaro S, Waldmann AD, Bohm SH, Ragazzi R, Marangoni E, Alvisi V, Spinelli E, Mauri T, Volta CA. Heterogeneity of regional inflection points from pressure-volume curves assessed by electrical impedance tomography. Crit Care. 2019 Apr 16;23(1):119. doi: 10.1186/s13054-019-2417-6.

  PMID: 30992054 DERIVED

• Spadaro S, Mauri T, Bohm SH, Scaramuzzo G, Turrini C, Waldmann AD, Ragazzi R, Pesenti A, Volta CA. Variation of poorly ventilated lung units (silent spaces) measured by electrical impedance tomography to dynamically assess recruitment. Crit Care. 2018 Jan 31;22(1):26. doi: 10.1186/s13054-017-1931-7.

  PMID: 29386048 DERIVED

Study Officials

• Savino Spadaro, MD

  Università degli Studi di Ferrara

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Study Record Dates

• First Submitted: September 5, 2016
• First Posted: September 20, 2016
• Study Start: April 1, 2016
• Primary Completion: January 1, 2017
• Study Completion: May 1, 2017
• Last Updated: May 8, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)