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

NCT03856424 | Unknown DMC

• 1 other identifier: TWEEP
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Evolution of pressure-time product of esophageal pressure

  Quantification of inspiratory effort of the patient

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

Secondary Outcomes (27)

• Evolution of work of breathing (WOB)

  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 inspiratory muscle pressure (Pmus)

  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 tidal volume (VT)

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

Study Arms (6)

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

OTHER

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.

Procedure: Modality 1; Procedure: Modality 2; Procedure: Modality 3

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

OTHER

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.

Procedure: Modality 1; Procedure: Modality 2; Procedure: Modality 3

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

OTHER

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.

Procedure: Modality 1; Procedure: Modality 2; Procedure: Modality 3

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

OTHER

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.

Procedure: Modality 1; Procedure: Modality 2; Procedure: Modality 3

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

OTHER

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.

Procedure: Modality 1; Procedure: Modality 2; Procedure: Modality 3

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

OTHER

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.

Procedure: Modality 1; Procedure: Modality 2; Procedure: Modality 3

Interventions

Modality 1 PROCEDURE

Pressure support ventilation (PSV) modality

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

Modality 2 PROCEDURE

T-Piece modality

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

Modality 3 PROCEDURE

High-flow oxygen

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Piquilloud Imboden Lise: lead

Study Sites (1)

Lausanne University Hospitals

Lausanne, Canton of Vaud, 1011, Switzerland

RECRUITING

MeSH Terms

Conditions

Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Lise Piquilloud Imboden, MER&PD

  University of Lausanne Hospitals

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lise Piquilloud Imboden, MER&PD

CONTACT

+41 79 556 68 27; lise.piquilloud@chuv.ch

Davy Cabrio

CONTACT

+41 79 556 69 56; davy.cabrio@chuv.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor-investigator

Model Details: 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.

Study Record Dates

• First Submitted: January 28, 2019
• First Posted: February 27, 2019
• Study Start: March 8, 2019
• Primary Completion: June 30, 2023
• Study Completion: December 30, 2023
• Last Updated: June 3, 2022

Record last verified: 2022-05

Locations

CH (1)