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

Primary Purpose

Acute Respiratory Failure

Status

Completed

Phase

Not Applicable

Locations

Italy

Study Type

Interventional

Intervention

Swisstom BB2

About this trial

This is an interventional diagnostic trial for Acute Respiratory Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Azienda Ospedaliero Universitaria Sant'Anna

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Recruitment

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT02907840

First Posted

September 5, 2016

Last Updated

May 5, 2017

Sponsor

Università degli Studi di Ferrara

1. Study Identification

Unique Protocol Identification Number

NCT02907840

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2017

Overall Recruitment Status

Completed

Study Start Date

April 2016 (Actual)

Primary Completion Date

January 2017 (Actual)

Study Completion Date

May 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Università degli Studi di Ferrara

4. Oversight

Data Monitoring Committee

5. Study Description

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: PEEP 5 centimeter of water (cmH2O) PEEP 10 cmH2O Recruitment maneuver followed by PEEP 15 cmH2O PEEP 10 cmH2O PEEP 5 cmH2O

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Respiratory Failure

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

14 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Recruitment

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Swisstom BB2

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Time Frame

Within 20 minutes from PEEP increase

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Savino Spadaro, MD

Organizational Affiliation

Università degli Studi di Ferrara

Official's Role

Principal Investigator

Facility Information:

Facility Name

Azienda Ospedaliero Universitaria Sant'Anna

City

Ferrara

ZIP/Postal Code

44121

Country

Italy

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

30992054

Citation

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.

Results Reference

derived

PubMed Identifier

29386048

Citation

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.

Results Reference

derived

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

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