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

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.

Study Overview

• Status: Completed
• Conditions: Acute Respiratory Failure
• Intervention / Treatment: Device: Swisstom BB2

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

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Ferrara, Italy, 44121
    • Azienda Ospedaliero Universitaria Sant'Anna

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Recruitment; Lung aeration monitored by Swisstom BB2 during PEEP steps and recruitment maneuver	Device: Swisstom 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Significant reduction in silent spaces (i.e. non ventilated lung areas) during incremental PEEP steps	Within 20 minutes from PEEP increase

Collaborators and Investigators

• Sponsor: Università degli Studi di Ferrara
• Investigators: Principal Investigator: Savino Spadaro, MD, Università degli Studi di Ferrara

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2016
• Primary Completion (Actual): January 1, 2017
• Study Completion (Actual): May 1, 2017

Study Registration Dates

• First Submitted: September 5, 2016
• First Submitted That Met QC Criteria: September 15, 2016
• First Posted (Estimate): September 20, 2016

Study Record Updates

• Last Update Posted (Actual): May 8, 2017
• Last Update Submitted That Met QC Criteria: May 5, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Respiratory Insufficiency; Respiratory Distress Syndrome
• Other Study ID Numbers: 141285

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO