Skip to main content
OpenTrials
Completed

NCT Number: NCT02907840

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Azienda Ospedaliero Universitaria Sant'Anna

Ferrara, 44121, Italy

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

Primary outcomes

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

    Time frame: Within 20 minutes from PEEP increase

Sponsors and collaborators

Lead sponsor

Università degli Studi di Ferrara

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Sep 20, 2016
Registry last updated
May 8, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.