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Effect of Three Modalities of Spontaneous Breathing Tests on Respiratory Efforts in Tracheostomized Patients (TWEEP)

Primary Purpose

Mechanical Ventilation Complication

Status
Recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Modality 1
Modality 2
Modality 3
Sponsored by
Piquilloud Imboden Lise
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Mechanical Ventilation Complication focused on measuring Ventilation, Tracheotomy, Difficult weaning, Spontaneous Breathing Test, Esophageal pressure, Work of breathing, Esophageal pressure time-product, Difficult weaning from mechanical ventilation, Ventilation weaning

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Lausanne University HospitalsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Other

Other

Other

Other

Other

Other

Arm Label

Modality 1 - Washout - Modality 2 - Washout - Modality 3

Modality 1 - Washout - Modality 3 - Washout - Modality 2

Modality 2 - Washout - Modality 1 - Washout - Modality 3

Modality 2 - Washout - Modality 3 - Washout - Modality 1

Modality 3 - Washout - Modality 2 - Washout - Modality 1

Modality 3 - Washout - Modality 1 - Washout - Modality 2

Arm Description

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.

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.

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

Evolution of pressure-time product of esophageal pressure
Quantification of inspiratory effort of the patient

Secondary Outcome Measures

Evolution of work of breathing (WOB)
Total area of a Campbell diagram for esophageal pressure and volume during one respiratory cycle
Evolution of esophageal pressure drop
Maximum variation of esophageal pressure during respiratory cycles
Evolution of inspiratory muscle pressure (Pmus)
Pressure generated by patients' respiratory muscles
Evolution of transdiaphragmatic pressure (Ptransdiaph)
Difference between gastric and esophageal pressure. Reflect of pressure generated by diaphragm during inspiration
Evolution of tidal volume (VT)
Evolution of respiratory rate (RR)
Evolution of inspiratory airway flow
Evolution of ratio of inspiratory time over total duration of a breathing cycle (ti/ttot)
Evolution of Rapid Shallow Breathing Index (RSBI)
RR/VT - predictor during ventilation weaning of intolerance of SBT
Evolution of respiratory system compliance (Crs)
Capacity of total respiratory system to gain volume for a given pressure
Evolution of lungs compliance (CL)
Capacity of lungs to gain volume for a given pressure
Evolution of chest wall compliance (Ccw)
Capacity of lungs to gain volume for a given pressure
Evolution of transpulmonary pressure (Ptranspulm)
Alveolar pressure minus pleural pressure
Evolution of ratio of total dead space volume over tidal volume
Calculated by means of expired CO2 and arterial blood gas CO2
Evolution of total dead space volume
Calculated by means of expired CO2
Evolution of total Positive End-Expiratory Pressure (PEEPtot)
Airway pressure during end-expiratory ventilator occlusion
Evolution of heart rate
Standard monitoring
Evolution of blood pressure
Standard monitoring
Evolution of Plateau pressure (Pplat)
Airway pressure during end-inspiratory ventilator occlusion (corresponds to alveolar pressure)
Evolution of intrinsic Positive End-Expiratory Pressure (PEEPi)
PEEPi minus PEEP set on ventilator
Pulmonary strain
Measured as the ratio of tidal volume over functionnal residual capacity (FRV)
Evolution of Diaphragmatic excursion (DE)
Ultrasound measurement of diaphragm movement during inspiration
Evolution of Diaphragmatic thickening fraction (DTF)
Ultrasound measurement of diaphragm thickening during inspiration
Evolution of hematocrits
Mesured by arterial blood
Evolution of Richmond Agitation/Sedation scale (RASS) score
Used in ICU to monitor neurologic changes in patients. Scale from -5 (unarousable) to +4 (combative). 0 is a calm and responsive patient.
Evolution of Borg dyspnea scale score
Numeric scale to quantify dyspnea from 0 to 10. 0 mean patient does not feel that breathing is difficult and 10 is a maximal dyspnea. Measured twice during each Spontaneous Breathing Trial
Evolution of Multidimensionnal dyspnea scale (MDP) score
Score to quantify comfort, dyspnea and assess respiratory effort as perceived by patient. This scale contains multiple items, divided in two dimensions : sensory and affective. Sensory dimension contains : intensity on a scale of 0 to 10 of five sensory qualities (physical breathing effort, air hunger, tightness, mental breathing effort, hyperpnoea) Affective dimension contains : a breathing discomfort scale (scale of 0 to 10) Measured once during each Spontaneous Breathing Trial

Full Information

First Posted
January 28, 2019
Last Updated
June 2, 2022
Sponsor
Piquilloud Imboden Lise
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1. Study Identification

Unique Protocol Identification Number
NCT03856424
Brief Title
Effect of Three Modalities of Spontaneous Breathing Tests on Respiratory Efforts in Tracheostomized Patients
Acronym
TWEEP
Official Title
Effect of Three Modalities of Spontaneous Breathing Tests on Respiratory Efforts in Tracheostomized Patients. Monocentric Crossover Interventionnal Study.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 8, 2019 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Piquilloud Imboden Lise

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
18 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Modality 1 - Washout - Modality 2 - Washout - Modality 3
Arm Type
Other
Arm Description
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.
Arm Title
Modality 1 - Washout - Modality 3 - Washout - Modality 2
Arm Type
Other
Arm Description
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.
Arm Title
Modality 2 - Washout - Modality 1 - Washout - Modality 3
Arm Type
Other
Arm Description
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.
Arm Title
Modality 2 - Washout - Modality 3 - Washout - Modality 1
Arm Type
Other
Arm Description
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.
Arm Title
Modality 3 - Washout - Modality 2 - Washout - Modality 1
Arm Type
Other
Arm Description
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.
Arm Title
Modality 3 - Washout - Modality 1 - Washout - Modality 2
Arm Type
Other
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Modality 1
Intervention Description
Pressure support ventilation (PSV) modality
Intervention Type
Procedure
Intervention Name(s)
Modality 2
Intervention Description
T-Piece modality
Intervention Type
Procedure
Intervention Name(s)
Modality 3
Intervention Description
High-flow oxygen
Primary Outcome Measure Information:
Title
Evolution of pressure-time product of esophageal pressure
Description
Quantification of inspiratory effort of the patient
Time Frame
Recorded every 5 minutes during each sequence and washout period, 180 minutes
Secondary Outcome Measure Information:
Title
Evolution of work of breathing (WOB)
Description
Total area of a Campbell diagram for esophageal pressure and volume during one respiratory cycle
Time Frame
Recorded every 5 minutes during each sequence and washout period, 180 minutes
Title
Evolution of esophageal pressure drop
Description
Maximum variation of esophageal pressure during respiratory cycles
Time Frame
Recorded every 5 minutes during each sequence and washout period, 180 minutes
Title
Evolution of inspiratory muscle pressure (Pmus)
Description
Pressure generated by patients' respiratory muscles
Time Frame
Recorded every 5 minutes during each sequence and washout period, 180 minutes
Title
Evolution of transdiaphragmatic pressure (Ptransdiaph)
Description
Difference between gastric and esophageal pressure. Reflect of pressure generated by diaphragm during inspiration
Time Frame
Recorded every 5 minutes during each sequence and washout period, 180 minutes
Title
Evolution of tidal volume (VT)
Time Frame
Recorded every 5 minutes during each sequence and washout period, 180 minutes
Title
Evolution of respiratory rate (RR)
Time Frame
Recorded every 5 minutes during each sequence and washout period, 180 minutes
Title
Evolution of inspiratory airway flow
Time Frame
Recorded every 5 minutes during each sequence and washout period, 180 minutes
Title
Evolution of ratio of inspiratory time over total duration of a breathing cycle (ti/ttot)
Time Frame
Recorded every 5 minutes during each sequence and washout period, 180 minutes
Title
Evolution of Rapid Shallow Breathing Index (RSBI)
Description
RR/VT - predictor during ventilation weaning of intolerance of SBT
Time Frame
Recorded every 5 minutes during each sequence and washout period, 180 minutes
Title
Evolution of respiratory system compliance (Crs)
Description
Capacity of total respiratory system to gain volume for a given pressure
Time Frame
Recorded every 5 minutes during each sequence and washout period, 180 minutes
Title
Evolution of lungs compliance (CL)
Description
Capacity of lungs to gain volume for a given pressure
Time Frame
Recorded every 5 minutes during each sequence and washout period, 180 minutes
Title
Evolution of chest wall compliance (Ccw)
Description
Capacity of lungs to gain volume for a given pressure
Time Frame
Recorded every 5 minutes during each sequence and washout period, 180 minutes
Title
Evolution of transpulmonary pressure (Ptranspulm)
Description
Alveolar pressure minus pleural pressure
Time Frame
Recorded every 5 minutes during each sequence and washout period, 180 minutes
Title
Evolution of ratio of total dead space volume over tidal volume
Description
Calculated by means of expired CO2 and arterial blood gas CO2
Time Frame
Recorded every 5 minutes during each sequence and washout period, 180 minutes
Title
Evolution of total dead space volume
Description
Calculated by means of expired CO2
Time Frame
Recorded every 5 minutes during each sequence and washout period, 180 minutes
Title
Evolution of total Positive End-Expiratory Pressure (PEEPtot)
Description
Airway pressure during end-expiratory ventilator occlusion
Time Frame
Recorded every 5 minutes during each sequence and washout period, 180 minutes
Title
Evolution of heart rate
Description
Standard monitoring
Time Frame
Recorded every 5 minutes during each sequence and washout period, 180 minutes
Title
Evolution of blood pressure
Description
Standard monitoring
Time Frame
Recorded every 5 minutes during each sequence and washout period, 180 minutes
Title
Evolution of Plateau pressure (Pplat)
Description
Airway pressure during end-inspiratory ventilator occlusion (corresponds to alveolar pressure)
Time Frame
Recorded at minute 1 and minute 30 of each three spontaneous Breathing Trial, 90 minutes
Title
Evolution of intrinsic Positive End-Expiratory Pressure (PEEPi)
Description
PEEPi minus PEEP set on ventilator
Time Frame
Recorded at minute 1 and minute 30 of each three spontaneous Breathing Trial, 90 minutes
Title
Pulmonary strain
Description
Measured as the ratio of tidal volume over functionnal residual capacity (FRV)
Time Frame
Recorded every 5 minutes during each sequence and washout period, 180 minutes
Title
Evolution of Diaphragmatic excursion (DE)
Description
Ultrasound measurement of diaphragm movement during inspiration
Time Frame
Recorded at minute 1 and minute 30 of each three spontaneous Breathing Trial, 90 minutes
Title
Evolution of Diaphragmatic thickening fraction (DTF)
Description
Ultrasound measurement of diaphragm thickening during inspiration
Time Frame
Recorded at minute 1 and minute 30 of each three spontaneous Breathing Trial, 90 minutes
Title
Evolution of hematocrits
Description
Mesured by arterial blood
Time Frame
Recorded at minute 30 of each three spontaneous Breathing Trial, 90 minutes
Title
Evolution of Richmond Agitation/Sedation scale (RASS) score
Description
Used in ICU to monitor neurologic changes in patients. Scale from -5 (unarousable) to +4 (combative). 0 is a calm and responsive patient.
Time Frame
Recorded at minute 1 and minute 30 of each three spontaneous Breathing Trial, 90 minutes
Title
Evolution of Borg dyspnea scale score
Description
Numeric scale to quantify dyspnea from 0 to 10. 0 mean patient does not feel that breathing is difficult and 10 is a maximal dyspnea. Measured twice during each Spontaneous Breathing Trial
Time Frame
Recorded at minute 1 and minute 30 of each three spontaneous Breathing Trial, 90 minutes
Title
Evolution of Multidimensionnal dyspnea scale (MDP) score
Description
Score to quantify comfort, dyspnea and assess respiratory effort as perceived by patient. This scale contains multiple items, divided in two dimensions : sensory and affective. Sensory dimension contains : intensity on a scale of 0 to 10 of five sensory qualities (physical breathing effort, air hunger, tightness, mental breathing effort, hyperpnoea) Affective dimension contains : a breathing discomfort scale (scale of 0 to 10) Measured once during each Spontaneous Breathing Trial
Time Frame
Recorded at minute 30 of each three spontaneous Breathing Trial, 90 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lise Piquilloud Imboden, MER&PD
Phone
+41 79 556 68 27
Email
lise.piquilloud@chuv.ch
First Name & Middle Initial & Last Name or Official Title & Degree
Davy Cabrio
Phone
+41 79 556 69 56
Email
davy.cabrio@chuv.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lise Piquilloud Imboden, MER&PD
Organizational Affiliation
University of Lausanne Hospitals
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lausanne University Hospitals
City
Lausanne
State/Province
Vaud
ZIP/Postal Code
1011
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lise Piquilloud Imboden, PD&MER
Phone
+41 79 556 68 27
Email
lise.piquilloud@chuv.ch

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Effect of Three Modalities of Spontaneous Breathing Tests on Respiratory Efforts in Tracheostomized Patients

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