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

NCT ID: NCT02907840

Last Updated: 2017-05-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2017-05-31

Brief Summary

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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

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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

Conditions

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Acute Respiratory Failure

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Recruitment

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

Group Type EXPERIMENTAL

Swisstom BB2

Intervention Type 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

Interventions

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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

Intervention Type DEVICE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Università degli Studi di Ferrara

OTHER

Sponsor Role lead

Responsible Party

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Savino Spadaro

Researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Savino Spadaro, MD

Role: PRINCIPAL_INVESTIGATOR

Università degli Studi di Ferrara

Locations

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Azienda Ospedaliero Universitaria Sant'Anna

Ferrara, , Italy

Site Status

Countries

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Italy

References

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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.

Reference Type DERIVED
PMID: 30992054 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29386048 (View on PubMed)

Other Identifiers

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141285

Identifier Type: -

Identifier Source: org_study_id

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