Effect of Three Modalities of Spontaneous Breathing Tests on Respiratory Efforts in Tracheostomized Patients. Monocentric Crossover Interventionnal Study.

Piquilloud Imboden Lise1 site in 1 country18 target enrollmentMarch 8, 2019

ConditionsMechanical Ventilation Complication

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Mechanical Ventilation Complication
Sponsor: Piquilloud Imboden Lise
Enrollment: 18
Locations: 1
Primary Endpoint: Evolution of pressure-time product of esophageal pressure
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Datas are lacking concerning weaning from mechanical ventilation for tracheostomized patients. In particular, the effect of different modalities of spontaneous breathing trials on respiratory effort has not been extensively described.

This crossover physiology study will include 18 tracheostomized patients ventilated for more than 72 hours.

The objective of this study is to compare the effect of three different modalities of SBTs on respiratory effort in tracheostomized patients. The modalities tested are : Pressure Support Ventilation (PSV level 5 cmH2O, PEEP 5 cmH2O), T-piece test and high-flow Oxygen. Each modality is applied in a randomized order, during 30 minutes. During every modality tested, esophageal and gastric pressure, expired CO2, and comfort will be monitored, in addition to standard monitoring. Based on esophageal pressure monitoring, patient's respiratory efforts can be calculated either by esophageal pressure-time product and work of breathing. Pressure generated by inspiratory muscles will also be assessed.

Registry

clinicaltrials.gov

Start Date

March 8, 2019

End Date

December 30, 2023

Last Updated

3 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Piquilloud Imboden Lise

Responsible Party

Sponsor Investigator

Principal Investigator

Piquilloud Imboden Lise

Sponsor-investigator

University of Lausanne Hospitals

Eligibility Criteria

Inclusion Criteria

•Patients for whom a tracheostomy is planned
•Patients on invasive ventilation for \>72 hours

Exclusion Criteria

•Tracheostomy for upper airway obstruction or other disease
•Patients tracheostomized before current hospitalization
•Patients with Glasgow Coma Scale (GCS) \< 8/10 after cardiac arrest
•Patients with GCS \< 8/10 because of primary central neurologic disease
•Patients for whom therapeutic limitations have already been decided
•Patients for whom weaning from ventilation is not an objective
•Patients suffering from myasthenia gravis
•Patients with cardiac assistance device
•Patients with medullary lesion proximal to C5
•Patients for whom nasogastric tube insertion is contraindicated

Outcomes

Primary Outcomes

Evolution of pressure-time product of esophageal pressure

Time Frame: Recorded every 5 minutes during each sequence and washout period, 180 minutes

Quantification of inspiratory effort of the patient

Secondary Outcomes

Evolution of work of breathing (WOB)(Recorded every 5 minutes during each sequence and washout period, 180 minutes)
Evolution of inspiratory muscle pressure (Pmus)(Recorded every 5 minutes during each sequence and washout period, 180 minutes)
Evolution of tidal volume (VT)(Recorded every 5 minutes during each sequence and washout period, 180 minutes)
Evolution of transdiaphragmatic pressure (Ptransdiaph)(Recorded every 5 minutes during each sequence and washout period, 180 minutes)
Evolution of inspiratory airway flow(Recorded every 5 minutes during each sequence and washout period, 180 minutes)
Evolution of blood pressure(Recorded every 5 minutes during each sequence and washout period, 180 minutes)
Evolution of chest wall compliance (Ccw)(Recorded every 5 minutes during each sequence and washout period, 180 minutes)
Evolution of esophageal pressure drop(Recorded every 5 minutes during each sequence and washout period, 180 minutes)
Evolution of respiratory rate (RR)(Recorded every 5 minutes during each sequence and washout period, 180 minutes)
Evolution of Rapid Shallow Breathing Index (RSBI)(Recorded every 5 minutes during each sequence and washout period, 180 minutes)
Evolution of ratio of total dead space volume over tidal volume(Recorded every 5 minutes during each sequence and washout period, 180 minutes)
Evolution of Plateau pressure (Pplat)(Recorded at minute 1 and minute 30 of each three spontaneous Breathing Trial, 90 minutes)
Evolution of intrinsic Positive End-Expiratory Pressure (PEEPi)(Recorded at minute 1 and minute 30 of each three spontaneous Breathing Trial, 90 minutes)
Pulmonary strain(Recorded every 5 minutes during each sequence and washout period, 180 minutes)
Evolution of total dead space volume(Recorded every 5 minutes during each sequence and washout period, 180 minutes)
Evolution of Diaphragmatic excursion (DE)(Recorded at minute 1 and minute 30 of each three spontaneous Breathing Trial, 90 minutes)
Evolution of Diaphragmatic thickening fraction (DTF)(Recorded at minute 1 and minute 30 of each three spontaneous Breathing Trial, 90 minutes)
Evolution of hematocrits(Recorded at minute 30 of each three spontaneous Breathing Trial, 90 minutes)
Evolution of ratio of inspiratory time over total duration of a breathing cycle (ti/ttot)(Recorded every 5 minutes during each sequence and washout period, 180 minutes)
Evolution of respiratory system compliance (Crs)(Recorded every 5 minutes during each sequence and washout period, 180 minutes)
Evolution of lungs compliance (CL)(Recorded every 5 minutes during each sequence and washout period, 180 minutes)
Evolution of transpulmonary pressure (Ptranspulm)(Recorded every 5 minutes during each sequence and washout period, 180 minutes)
Evolution of total Positive End-Expiratory Pressure (PEEPtot)(Recorded every 5 minutes during each sequence and washout period, 180 minutes)
Evolution of heart rate(Recorded every 5 minutes during each sequence and washout period, 180 minutes)
Evolution of Richmond Agitation/Sedation scale (RASS) score(Recorded at minute 1 and minute 30 of each three spontaneous Breathing Trial, 90 minutes)
Evolution of Borg dyspnea scale score(Recorded at minute 1 and minute 30 of each three spontaneous Breathing Trial, 90 minutes)
Evolution of Multidimensionnal dyspnea scale (MDP) score(Recorded at minute 30 of each three spontaneous Breathing Trial, 90 minutes)