Effect of Three Modalities of Spontaneous Breathing Tests on Respiratory Efforts in Tracheostomized Patients
NCT ID: NCT03856424
Last Updated: 2022-06-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
18 participants
INTERVENTIONAL
2019-03-08
2023-12-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
OTHER
NONE
Study Groups
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Modality 1 - Washout - Modality 2 - Washout - Modality 3
Three different 30-minute modalities of deventilation will be performed in a randomized order in each patient. Washout periods of 30 minutes will occur between tested modalities.
Modality 1
Pressure support ventilation (PSV) modality
Modality 2
T-Piece modality
Modality 3
High-flow oxygen
Modality 1 - Washout - Modality 3 - Washout - Modality 2
Three different 30-minute modalities of deventilation will be performed in a randomized order in each patient. Washout periods of 30 minutes will occur between tested modalities.
Modality 1
Pressure support ventilation (PSV) modality
Modality 2
T-Piece modality
Modality 3
High-flow oxygen
Modality 2 - Washout - Modality 1 - Washout - Modality 3
Three different 30-minute modalities of deventilation will be performed in a randomized order in each patient. Washout periods of 30 minutes will occur between tested modalities.
Modality 1
Pressure support ventilation (PSV) modality
Modality 2
T-Piece modality
Modality 3
High-flow oxygen
Modality 2 - Washout - Modality 3 - Washout - Modality 1
Three different 30-minute modalities of deventilation will be performed in a randomized order in each patient. Washout periods of 30 minutes will occur between tested modalities.
Modality 1
Pressure support ventilation (PSV) modality
Modality 2
T-Piece modality
Modality 3
High-flow oxygen
Modality 3 - Washout - Modality 2 - Washout - Modality 1
Three different 30-minute modalities of deventilation will be performed in a randomized order in each patient. Washout periods of 30 minutes will occur between tested modalities.
Modality 1
Pressure support ventilation (PSV) modality
Modality 2
T-Piece modality
Modality 3
High-flow oxygen
Modality 3 - Washout - Modality 1 - Washout - Modality 2
Three different 30-minute modalities of deventilation will be performed in a randomized order in each patient. Washout periods of 30 minutes will occur between tested modalities.
Modality 1
Pressure support ventilation (PSV) modality
Modality 2
T-Piece modality
Modality 3
High-flow oxygen
Interventions
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Modality 1
Pressure support ventilation (PSV) modality
Modality 2
T-Piece modality
Modality 3
High-flow oxygen
Eligibility Criteria
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Inclusion Criteria
* Patients on invasive ventilation for \>72 hours
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Piquilloud Imboden Lise
OTHER
Responsible Party
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Piquilloud Imboden Lise
Sponsor-investigator
Principal Investigators
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Lise Piquilloud Imboden, MER&PD
Role: PRINCIPAL_INVESTIGATOR
University of Lausanne Hospitals
Locations
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Lausanne University Hospitals
Lausanne, Canton of Vaud, Switzerland
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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TWEEP
Identifier Type: -
Identifier Source: org_study_id
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