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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02907840
First Posted: September 20, 2016
Last Update Posted: May 8, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Savino Spadaro, Università degli Studi di Ferrara
  Purpose
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.

Condition Intervention
Acute Respiratory Failure Device: Swisstom BB2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Prediction of Response to Recruitment Maneuvers in Patients With Acute Respiratory Failure

Resource links provided by NLM:


Further study details as provided by Savino Spadaro, Università degli Studi di Ferrara:

Primary Outcome Measures:
  • Significant reduction in silent spaces (i.e. non ventilated lung areas) during incremental PEEP steps [ Time Frame: Within 20 minutes from PEEP increase ]

Enrollment: 14
Actual Study Start Date: April 2016
Study Completion Date: May 2017
Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02907840


Locations
Italy
Azienda Ospedaliero Universitaria Sant'Anna
Ferrara, Italy, 44121
Sponsors and Collaborators
Università degli Studi di Ferrara
Investigators
Principal Investigator: Savino Spadaro, MD Università degli Studi di Ferrara
  More Information

Responsible Party: Savino Spadaro, Researcher, Università degli Studi di Ferrara
ClinicalTrials.gov Identifier: NCT02907840     History of Changes
Other Study ID Numbers: 141285
First Submitted: September 5, 2016
First Posted: September 20, 2016
Last Update Posted: May 8, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Respiratory Insufficiency
Respiratory Distress Syndrome, Adult
Respiration Disorders
Respiratory Tract Diseases
Lung Diseases