Ventilation Strategies During Spontaneous Breathing Trial

Acute Respiratory Insufficiency Clinical Trial

— WEANING  

Official title:

Comparison of Two Ventilatory Modes During Spontaneous Breathing Trial in Intubated Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02939963
• Other study ID #: 69HCL16_0411
• Secondary ID: 2016-A01172-49
• Status: Completed
• Phase: N/A
• Start date: August 23, 2017
• Est. completion date: October 5, 2018

Study information

• Verified date: November 2018
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Patients who are intubated and mechanically ventilated for acute respiratory failure in the Intensive Care Unit (ICU) are at some point eligible for weaning. The common way to wean them from mechanical ventilation is to screen criteria for feasibility and, if present, to test feasibility by performing spontaneous breathing trial. This latter can be done either by setting a low pressure support level (expected to compensate the airflow resistance due to endotracheal tube) or by allowing the patient to breathe spontaneously through the tube without any support from the ventilator. Combination of low pressure assistance strategy (7 cm H2O) and positive expiratory pressure (PEP) of 4 cm H2O is the strategy used in our unit. Such a low pressure support level should actually result in a real assistance and, hence this is not the real spontaneous breathing capacity that is tested. Some ICU ventilators offer the option of compensating for the airflow resistance due to endotracheal tube, automatic tube compensation (ATC). Therefore, investigators aimed at comparing in patients ready to wean the usual procedure in our ICU and the ATC mode. In the ATC arm, the patients are breathing spontaneously through the endotracheal tube and are connected to the ventilator set at inspiratory pressure support of 0 cm H2O, PEP 4 cm H2O and ATC on.

Two parallel arms depending on the order of allocation of each mode: pressure support 7 cm H2O + PEP 4 cm H2O then ATC or the opposite. The primary endpoint is the power of the work of breathing. The hypothesis is that the power of the work of breathing is greater in ATC than in the usual procedure, and hence this latter is a real ventilator support.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 5, 2018
• Est. primary completion date: October 5, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• age 18 years or more

• intubated and mechanically ventilated for at least 24 consecutive hours

• staying in the medical ICU at the Croix Rousse Hospital, Lyon, France

• pressure support ventilation 10-15 cm H2O, total respiratory rate 25-35 breaths/min, expired tidal volume 6-8 ml/kg predicted body weight

• meeting criteria for spontaneous breathing trial (able to answer simple questions, no ongoing intravenous sedation, norepinephrine = 1 mg/H, dobutamine = 20 mg/h, fraction of inspired oxygen (FIO2 = 50%), PEP = 5 cm H2O, respiratory rate = 35 breaths/min, saturation in oxygen (SpO2) =88%)

• under Dräger Evita XL ou V500 ICU ventilator

• agreement to participate from the patient or next of kin

Exclusion Criteria:

• Chronic respiratory failure under long term home oxygen therapy and/or non invasive ventilation before ICU admission

• Tracheotomy

• nasogastric tube contra-indicated

• thoracic tube in place

• no agreement to participate

• under justice protection

• deprived of freedom

• pregnant or breastfeeding

• not affiliated to social insurance

• involved into another study that may interfere with present study

Related Conditions & MeSH terms

• Acute Respiratory Insufficiency
• Pulmonary Valve Insufficiency
• Respiratory Aspiration
• Respiratory Insufficiency

Intervention

Procedure:
• ATC then pressure support 7 cm H2O PEP 4 cm H2O
spontaneous breathing through endotracheal tube with no ventilator support except for ATC, the patient is connected to the ventilator with pressure support 0 cm H2O and PEP 4 cm H2O during 30 minutes then 30 minutes of basal pressure support then 30 minutes with pressure support 7 cm H2O PEP 4 cm H2O
• Pressure support 7 cm H2O PEP 4 cm H2O then ATC
30 minutes with pressure support 7 cm H2O PEP 4 cm H2O then 30 minutes of basal pressure support then 30 minutes with spontaneous breathing through endotracheal tube with no ventilator support except for ATC, the patient is connected to the ventilator with pressure support 0 cm H2O and PEP 4 cm H2O

Locations

Country	Name	City	State
France	Hôpital de la Croix Rousse	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the power of work of breathing	the work of breathing is measured from the area subtended by the esophageal pressure - lung volume relationship. The power of work of breathing is obtained by multiplying work of breathing by the respiratory frequency and expressed in Joules/min	30 minutes after onset the ventilator strategy
Secondary	Respiratory rate	the respiratory rate is measured from the airflow tracing	30 minutes
Secondary	tidal volume	integration of airflow over time during expiration	30 minutes
Secondary	intrinsic PEP	deflection in esophageal pressure up to the first zero flow	30 minutes
Secondary	occlusion pressure at 100 ms	measured from the airway pressure at the first 100 ms after airway occlusion	30 minutes
Secondary	work of breathing per liter	work of breathing normalized for 1 liter tidal volume	30 minutes
Secondary	Distribution of pulmonary ventilation	distribution of pulmonary ventilation will be measured by the Pulmovista system	30 minutes