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

• Register: ClinicalTrials.gov
• Last refreshed on: 13 June 2022
• Main ID: NCT03856424
• Date of registration: 28/01/2019
• Prospective Registration: Yes
• Primary sponsor: Piquilloud Imboden Lise
• Public title: Effect of Three Modalities of Spontaneous Breathing Tests on Respiratory Efforts in Tracheostomized Patients TWEEP
• Scientific title: Effect of Three Modalities of Spontaneous Breathing Tests on Respiratory Efforts in Tracheostomized Patients. Monocentric Crossover Interventionnal Study.
• Date of first enrolment: March 8, 2019
• Target sample size: 18
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT03856424
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Other. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Switzerland

Contacts

• Name: Lise Piquilloud Imboden, PD&MER

• Name: Lise Piquilloud Imboden, MER&PD

• Name: Lise Piquilloud Imboden, MER&PD
• Affiliation: University of Lausanne Hospitals

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Mechanical Ventilation Complication

Intervention(s)

Procedure: Modality 1

Procedure: Modality 2

Procedure: Modality 3

Primary Outcome(s)

Evolution of pressure-time product of esophageal pressure [Time Frame: Recorded every 5 minutes during each sequence and washout period, 180 minutes]

Secondary Outcome(s)

Evolution of esophageal pressure drop [Time Frame: Recorded every 5 minutes during each sequence and washout period, 180 minutes]

Evolution of Diaphragmatic excursion (DE) [Time Frame: Recorded at minute 1 and minute 30 of each three spontaneous Breathing Trial, 90 minutes]

Evolution of inspiratory airway flow [Time Frame: Recorded every 5 minutes during each sequence and washout period, 180 minutes]

Evolution of intrinsic Positive End-Expiratory Pressure (PEEPi) [Time Frame: Recorded at minute 1 and minute 30 of each three spontaneous Breathing Trial, 90 minutes]

Evolution of Plateau pressure (Pplat) [Time Frame: Recorded at minute 1 and minute 30 of each three spontaneous Breathing Trial, 90 minutes]

Evolution of heart rate [Time Frame: Recorded every 5 minutes during each sequence and washout period, 180 minutes]

Evolution of Multidimensionnal dyspnea scale (MDP) score [Time Frame: 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) [Time Frame: Recorded every 5 minutes during each sequence and washout period, 180 minutes]

Evolution of respiratory rate (RR) [Time Frame: Recorded every 5 minutes during each sequence and washout period, 180 minutes]

Evolution of transdiaphragmatic pressure (Ptransdiaph) [Time Frame: Recorded every 5 minutes during each sequence and washout period, 180 minutes]

Evolution of blood pressure [Time Frame: Recorded every 5 minutes during each sequence and washout period, 180 minutes]

Evolution of Borg dyspnea scale score [Time Frame: Recorded at minute 1 and minute 30 of each three spontaneous Breathing Trial, 90 minutes]

Evolution of Diaphragmatic thickening fraction (DTF) [Time Frame: Recorded at minute 1 and minute 30 of each three spontaneous Breathing Trial, 90 minutes]

Pulmonary strain [Time Frame: Recorded every 5 minutes during each sequence and washout period, 180 minutes]

Evolution of inspiratory muscle pressure (Pmus) [Time Frame: Recorded every 5 minutes during each sequence and washout period, 180 minutes]

Evolution of tidal volume (VT) [Time Frame: Recorded every 5 minutes during each sequence and washout period, 180 minutes]

Evolution of Richmond Agitation/Sedation scale (RASS) score [Time Frame: Recorded at minute 1 and minute 30 of each three spontaneous Breathing Trial, 90 minutes]

Evolution of work of breathing (WOB) [Time Frame: Recorded every 5 minutes during each sequence and washout period, 180 minutes]

Evolution of chest wall compliance (Ccw) [Time Frame: Recorded every 5 minutes during each sequence and washout period, 180 minutes]

Evolution of respiratory system compliance (Crs) [Time Frame: Recorded every 5 minutes during each sequence and washout period, 180 minutes]

Evolution of total dead space volume [Time Frame: Recorded every 5 minutes during each sequence and washout period, 180 minutes]

Evolution of hematocrits [Time Frame: Recorded at minute 30 of each three spontaneous Breathing Trial, 90 minutes]

Evolution of lungs compliance (CL) [Time Frame: Recorded every 5 minutes during each sequence and washout period, 180 minutes]

Evolution of Rapid Shallow Breathing Index (RSBI) [Time Frame: Recorded every 5 minutes during each sequence and washout period, 180 minutes]

Evolution of ratio of total dead space volume over tidal volume [Time Frame: Recorded every 5 minutes during each sequence and washout period, 180 minutes]

Evolution of total Positive End-Expiratory Pressure (PEEPtot) [Time Frame: Recorded every 5 minutes during each sequence and washout period, 180 minutes]

Evolution of transpulmonary pressure (Ptranspulm) [Time Frame: Recorded every 5 minutes during each sequence and washout period, 180 minutes]

Secondary ID(s)

TWEEP

Source(s) of Monetary Support

Please refer to primary and secondary sponsors