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

Acute Respiratory Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02907840
• Other study ID #: 141285
• Status: Completed
• Phase: N/A
• First received: September 5, 2016
• Last updated: May 5, 2017
• Start date: April 2016
• Est. completion date: May 2017

Study information

• Verified date: May 2017
• Source: Università degli Studi di Ferrara
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: May 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Acute Respiratory Failure
• Respiratory Distress Syndrome, Adult
• Respiratory Insufficiency

Intervention

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

Locations

Country	Name	City	State
Italy	Azienda Ospedaliero Universitaria Sant'Anna	Ferrara

Sponsors (1)

Lead Sponsor	Collaborator
Università degli Studi di Ferrara

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Significant reduction in silent spaces (i.e. non ventilated lung areas) during incremental PEEP steps		Within 20 minutes from PEEP increase