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

Not Applicable

Not yet recruiting

• Conditions: Prolonged Weaning
• Interventions: Device: low pressure tracheostomy cannulas; Device: plated balloon tracheostomy cannulas

• Registration Number: NCT06185998
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

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.

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 Timeline

• Study First Submitted: 2023-11-23
• Status Verified: 2023-12
• Study First Submitted QC: 2023-12-14
• Study First Posted: 2023-12-29
• Last Update Submitted: 2024-07-18
• Last Update Posted: 2024-07-19
• Study Start: 2024-09
• Primary Completion: 2026-10
• Study Completion: 2026-10

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 76

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
plated balloon tracheostomy cannulas	plated balloon tracheostomy cannulas	4 interfaces are tested: cap, ventilator, filter and phonation valve
plated balloon tracheostomy cannulas	low pressure tracheostomy cannulas	4 interfaces are tested: cap, ventilator, filter and phonation valve
low pressure balloon tracheotomy cannulas	low pressure tracheostomy cannulas	4 interfaces are tested: cap, ventilator, filter and phonation valve
low pressure balloon tracheotomy cannulas	plated balloon tracheostomy cannulas	4 interfaces are tested: cap, ventilator, filter and phonation valve

Primary Outcome Measures

Name	Time	Method
Dyspnea visual analogic scale (VAS) with cap	30 minutes after using each interfaces	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.

Secondary Outcome Measures

Name	Time	Method
Biological variable : Pulsed oxygen saturation	30 minutes after using each interfaces	Pulsed oxygen saturation (percentage %)
Biological variable : Respiratory rate	30 minutes after using each interfaces	Respiratory rate (cycles per minute)
Anxiety visual analogic scales (VAS)	30 minutes after using each interfaces	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
use of anxiolytic drugs	30 minutes after using each interfaces	the type of molecule, dosage and route of administration will be identified
Multidimensional Dyspnea Profile (MDP)	30 minutes after using each interfaces	The Multidimensional Dyspnea Profile (MDP) assesses overall breathing discomfort, sensory qualities, and emotional responses
Biological variable : Systolic and diastolic systemic blood pressure	30 minutes after using each interfaces	Systolic and diastolic systemic blood pressure (millimeters of mercury - mmHg)
Pain visual analogic scales (VAS)	30 minutes after using each interfaces	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
Dyspnea visual analogic scale (VAS) after 30 min breathing with filter, ventilator and phonation valve	30 minutes after using each interfaces	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.
Biological variable : Heart rate	30 minutes after using each interfaces	Heart rate (beat per minute)
use of analgesic anti dyspnoetics drugs (morphine and derivatives)	30 minutes after using each interfaces	the type of molecule, dosage and route of administration will be identified