Clinical trial NCT03856424: Effect of Three Modalities of Spontaneous Breathing Tests on Respiratory Efforts in Tracheostomized Patients
Official title: Effect of Three Modalities of Spontaneous Breathing Tests on Respiratory Efforts in Tracheostomized Patients. Monocentric Crossover Interventionnal Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mechanical Ventilation Complication
Keywords: Ventilation
Tracheotomy
Difficult weaning
Spontaneous Breathing Test
Esophageal pressure
Work of breathing
Esophageal pressure time-product
Difficult weaning from mechanical ventilation
Ventilation weaning
Lead sponsor: University of Lausanne Hospitals
Sponsor class: OTHER
First posted: 2019-02-27
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Three different spontaneous breathing trials modalities will be tested in each patient in a randomized order. Washout periods will be performed between the tested modalities.
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: Evolution of pressure-time product of esophageal pressure
timeFrame: Recorded every 5 minutes during each sequence and washout period, 180 minutes
Secondary outcomes:
measure: Evolution of work of breathing (WOB)
timeFrame: Recorded every 5 minutes during each sequence and washout period, 180 minutes
measure: Evolution of esophageal pressure drop
timeFrame: Recorded every 5 minutes during each sequence and washout period, 180 minutes
measure: Evolution of inspiratory muscle pressure (Pmus)
timeFrame: Recorded every 5 minutes during each sequence and washout period, 180 minutes
measure: Evolution of transdiaphragmatic pressure (Ptransdiaph)
timeFrame: Recorded every 5 minutes during each sequence and washout period, 180 minutes
measure: Evolution of tidal volume (VT)
timeFrame: Recorded every 5 minutes during each sequence and washout period, 180 minutes
measure: Evolution of respiratory rate (RR)
timeFrame: Recorded every 5 minutes during each sequence and washout period, 180 minutes
measure: Evolution of inspiratory airway flow
timeFrame: Recorded every 5 minutes during each sequence and washout period, 180 minutes
measure: Evolution of ratio of inspiratory time over total duration of a breathing cycle (ti/ttot)
timeFrame: Recorded every 5 minutes during each sequence and washout period, 180 minutes
measure: Evolution of Rapid Shallow Breathing Index (RSBI)
timeFrame: Recorded every 5 minutes during each sequence and washout period, 180 minutes
measure: Evolution of respiratory system compliance (Crs)
timeFrame: Recorded every 5 minutes during each sequence and washout period, 180 minutes
measure: Evolution of lungs compliance (CL)
timeFrame: Recorded every 5 minutes during each sequence and washout period, 180 minutes
measure: Evolution of chest wall compliance (Ccw)
timeFrame: Recorded every 5 minutes during each sequence and washout period, 180 minutes
measure: Evolution of transpulmonary pressure (Ptranspulm)
timeFrame: Recorded every 5 minutes during each sequence and washout period, 180 minutes
measure: Evolution of ratio of total dead space volume over tidal volume
timeFrame: Recorded every 5 minutes during each sequence and washout period, 180 minutes
measure: Evolution of total dead space volume
timeFrame: Recorded every 5 minutes during each sequence and washout period, 180 minutes
measure: Evolution of total Positive End-Expiratory Pressure (PEEPtot)
timeFrame: Recorded every 5 minutes during each sequence and washout period, 180 minutes
measure: Evolution of heart rate
timeFrame: Recorded every 5 minutes during each sequence and washout period, 180 minutes
measure: Evolution of blood pressure
timeFrame: Recorded every 5 minutes during each sequence and washout period, 180 minutes
measure: Evolution of Plateau pressure (Pplat)
timeFrame: Recorded at minute 1 and minute 30 of each three spontaneous Breathing Trial, 90 minutes
measure: Evolution of intrinsic Positive End-Expiratory Pressure (PEEPi)
timeFrame: Recorded at minute 1 and minute 30 of each three spontaneous Breathing Trial, 90 minutes
measure: Pulmonary strain
timeFrame: Recorded every 5 minutes during each sequence and washout period, 180 minutes
measure: Evolution of Diaphragmatic excursion (DE)
timeFrame: Recorded at minute 1 and minute 30 of each three spontaneous Breathing Trial, 90 minutes
measure: Evolution of Diaphragmatic thickening fraction (DTF)
timeFrame: Recorded at minute 1 and minute 30 of each three spontaneous Breathing Trial, 90 minutes
measure: Evolution of hematocrits
timeFrame: Recorded at minute 30 of each three spontaneous Breathing Trial, 90 minutes
measure: Evolution of Richmond Agitation/Sedation scale (RASS) score
timeFrame: Recorded at minute 1 and minute 30 of each three spontaneous Breathing Trial, 90 minutes
measure: Evolution of Borg dyspnea scale score
timeFrame: Recorded at minute 1 and minute 30 of each three spontaneous Breathing Trial, 90 minutes
measure: Evolution of Multidimensionnal dyspnea scale (MDP) score
timeFrame: Recorded at minute 30 of each three spontaneous Breathing Trial, 90 minutes
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Lausanne University Hospitals
state: Vaud
Study officials:
affiliation: University of Lausanne Hospitals
name: Lise Piquilloud Imboden, MER&PD
role: PRINCIPAL_INVESTIGATOR
References: