Impact of the Nature and Interface of the Tracheostomy Cannula on Dyspnea in Patients Weaning From Artificial Ventilation in Weaning Unit (DYSTRACH)

This trial aims to assess dyspnea intensity in tracheostomized patients undergoing prolonged artificial ventilation weaning. The primary outcome is dyspnea measured by the Visual Analogue Scale (VAS-Dyspnea). A comparison between low-pressure balloon tracheostomy cannula and plated balloon cannula and four interfaces (Cap, ventilator, phonation valve, or filter) are tested. The secondary outcomes including Multidimensional Dyspnea Profile, pain, anxiety VAS, and tolerance under different interfaces. The multicenter, cross-over study involves 76 patients over 25 months, each serving as their own control. Cap is always evaluated first but the order of the three interfaces (ventilator, phonation valve, or filter) and type of cannula are chosen by randomization. The study is conducted in three weaning centers (SRPR units) at Pitié-Salpêtrière, Bligny, and Forcilles.

Study Overview

• Status: Not yet recruiting
• Conditions: Prolonged Weaning
• Intervention / Treatment: Device: low pressure tracheostomy cannulas; Device: plated balloon tracheostomy cannulas

Detailed Description

Dyspnea is common in patients ventilated in intensive care and SRPR units, and it can generate states of post-traumatic stress. Due to the prolonged duration of artificial ventilation, tracheostomized patients, for the purpose of prolonged weaning from artificial ventilation, are particularly exposed to dyspnea.

The main objective is to compare the respective impact of a low-pressure balloon tracheostomy cannula and a plated balloon cannula on the dyspnea intensity of tracheostomized patients in spontaneous ventilation, with the cannula closed by a cap. The primary outcome is the Visual Analogue Scale (VAS) for dyspnea (VAS-Dyspnea).

The investigators will compare low pressure versus plated balloon tracheostomy cannulas, considering the sensory and emotional components of dyspnea, as well as tolerance, pain, comfort, and anxiety under four different interfaces: ventilator, phonation valve, Cap, or filter. This will be measured through the following secondary outcomes:

• VAS-Dyspnea
• Multidimensional Dyspnea Profile
• Pain and anxiety VAS This multicenter study (SRPR Pitié-Salpêtrière, Bligny, and Forcilles) will be randomized in a cross-over design, comparing the use of two types of low-pressure or plated balloon cannulas over two consecutive days. For each cannula, four interfaces will be connected in a row starting with the cap. The order in which the other three interfaces will be set up will be randomized (ventilator, filter, and phonation valve).

It is a cross-over including 76 patients, with each serving as their his own control, over 25 months.

• Study Type: Interventional
• Enrollment (Estimated): 76
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Julie Delemazure; Phone Number: +33 1 84 82 75 72; Email: julie.delemazure@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patient aged 18 years or older
• Patient admitted to SRPR with respiratory and hemodynamic stability
• Patient with a tracheostomy tube
• Deflated balloon for more than 6 hours per day
• Able to tolerate at least 1 hour on cap and phonation valve (deflated balloon)
• Able to remain at least 3 consecutive hours without ventilation
• Patient with at least one non-zero dyspnea numerical rating scale (NRS) score in the 72 hours preceding inclusion
• Able to respond to self-administered questionnaires on dyspnea
• Patients affiliated with a social security system or beneficiaries of such a system (excluding State Medical Assistance)
• Patients who have given their informed consent
• No significant expected changes in the administration of anxiolytic and analgesic treatments with anti-dyspneic properties within 2 days

Exclusion Criteria:

• Pregnant women (verified by a blood or urine test during hospitalization for all women of childbearing age)
• Patients deprived of liberty or under legal protection (guardianship or curatorship)
• Patients unable to consent to the research
• Contraindication to the use of a 7 mm tracheostomy tube
• Patient presenting the combination of major swallowing disorders and excessive salivary secretion making the deflation of the tracheostomy tube balloon

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: plated balloon tracheostomy cannulas; 4 interfaces are tested: cap, ventilator, filter and phonation valve	Device: low pressure tracheostomy cannulas; The tracheostomy tube is changed according to the randomization sequence, a filter is connected for 5 minutes; then baseline data will be assessed. The tracheostomy tube is then connected to the four interfaces for 30 minutes each. Parameters is measured after each 30-minute period. The cuff of the tracheostomy tube will be deflated using a syringe when the interface is a filter, phonation valve, or cap. In contrast, the cuff will be inflated when the interface is the ventilator. The cuff is inflated with a manometer for the low-pressure balloon tracheostomy tube and with the minimum and sufficient amount of injectable water for the plated balloon tracheostomy tube to avoid overpressure; Other Names: non fenestrated TRACOE® twist; TRACOE tracheostomy tubes with low-pressure cuff; low wall thickness and a good fit of the inner cannula in the outer cannula; Device: plated balloon tracheostomy cannulas; The tracheostomy tube is changed according to the randomization sequence, a filter is connected for 5 minutes; then baseline data will be assessed. The tracheostomy tube is then connected to the four interfaces for 30 minutes each. Parameters is measured after each 30-minute period. The cuff of the tracheostomy tube will be deflated using a syringe when the interface is a filter, phonation valve, or cap. In contrast, the cuff will be inflated when the interface is the ventilator. The cuff is inflated with a manometer for the low-pressure balloon tracheostomy tube and with the minimum and sufficient amount of injectable water for the plated balloon tracheostomy tube to avoid overpressure; Other Names: Bivona® TTS™ Tracheostomy Tubes; silicone tube TTS™ cuff; tubes are coated with a SuperSlick®; soft, confort and flexible tube
Active Comparator: low pressure balloon tracheotomy cannulas; 4 interfaces are tested: cap, ventilator, filter and phonation valve	Device: low pressure tracheostomy cannulas; The tracheostomy tube is changed according to the randomization sequence, a filter is connected for 5 minutes; then baseline data will be assessed. The tracheostomy tube is then connected to the four interfaces for 30 minutes each. Parameters is measured after each 30-minute period. The cuff of the tracheostomy tube will be deflated using a syringe when the interface is a filter, phonation valve, or cap. In contrast, the cuff will be inflated when the interface is the ventilator. The cuff is inflated with a manometer for the low-pressure balloon tracheostomy tube and with the minimum and sufficient amount of injectable water for the plated balloon tracheostomy tube to avoid overpressure; Other Names: non fenestrated TRACOE® twist; TRACOE tracheostomy tubes with low-pressure cuff; low wall thickness and a good fit of the inner cannula in the outer cannula; Device: plated balloon tracheostomy cannulas; The tracheostomy tube is changed according to the randomization sequence, a filter is connected for 5 minutes; then baseline data will be assessed. The tracheostomy tube is then connected to the four interfaces for 30 minutes each. Parameters is measured after each 30-minute period. The cuff of the tracheostomy tube will be deflated using a syringe when the interface is a filter, phonation valve, or cap. In contrast, the cuff will be inflated when the interface is the ventilator. The cuff is inflated with a manometer for the low-pressure balloon tracheostomy tube and with the minimum and sufficient amount of injectable water for the plated balloon tracheostomy tube to avoid overpressure; Other Names: Bivona® TTS™ Tracheostomy Tubes; silicone tube TTS™ cuff; tubes are coated with a SuperSlick®; soft, confort and flexible tube

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dyspnea visual analogic scale (VAS) with cap	The VAS of dyspnoea evaluate the severity of dyspnoea, the index has 10 numerical values, rated on a scale from 0-10, each value corresponding to an intensity of breathlessness. It is an easy-to-use scale for patients.	30 minutes after using each interfaces

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dyspnea visual analogic scale (VAS) after 30 min breathing with filter, ventilator and phonation valve	The VAS of dyspnoea evaluate the severity of dyspnoea, the index has 10 numerical values, rated on a scale from 0-10, each value corresponding to an intensity of breathlessness. It is an easy-to-use scale for patients.	30 minutes after using each interfaces
Multidimensional Dyspnea Profile (MDP)	The Multidimensional Dyspnea Profile (MDP) assesses overall breathing discomfort, sensory qualities, and emotional responses	30 minutes after using each interfaces
Biological variable : Heart rate	Heart rate (beat per minute)	30 minutes after using each interfaces
Biological variable : Respiratory rate	Respiratory rate (cycles per minute)	30 minutes after using each interfaces
Biological variable : Systolic and diastolic systemic blood pressure	Systolic and diastolic systemic blood pressure (millimeters of mercury - mmHg)	30 minutes after using each interfaces
Biological variable : Pulsed oxygen saturation	Pulsed oxygen saturation (percentage %)	30 minutes after using each interfaces
Pain visual analogic scales (VAS)	evaluate the severity of pain the index has 10 numerical values, rated on a scale from 0-10, each value corresponding to an intensity pain and anxiety. It is an easy-to-use scale for patients	30 minutes after using each interfaces
Anxiety visual analogic scales (VAS)	evaluate the severity of anxiety the index has 10 numerical values, rated on a scale from 0-10, each value corresponding to an intensity pain and anxiety. It is an easy-to-use scale for patients	30 minutes after using each interfaces
use of analgesic anti dyspnoetics drugs (morphine and derivatives)	the type of molecule, dosage and route of administration will be identified	30 minutes after using each interfaces
use of anxiolytic drugs	the type of molecule, dosage and route of administration will be identified	30 minutes after using each interfaces

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Julie Delemazure, Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2024
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: November 23, 2023
• First Submitted That Met QC Criteria: December 14, 2023
• First Posted (Actual): December 29, 2023

Study Record Updates

• Last Update Posted (Actual): December 29, 2023
• Last Update Submitted That Met QC Criteria: December 14, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: dyspnea; tracheostomy; prolonged weaning
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Dyspnea
• Other Study ID Numbers: APHP230863

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.
• IPD Sharing Time Frame: Beginning 3 months and ending 3 years following article publication. Requests out of these time frame can also be submitted to the sponsor
• IPD Sharing Access Criteria: Researchers who provide a methodologically sound proposal.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No