Physiological Effect High-flow Tracheal Oxygen on Viscosity of Airway Mucus and Respiratory Effort in Patients Weaning from Invasive Mechanical Ventilation

NCT06776939 | Recruiting

• 2 other identifiers: MEC-2024-0468NL87502.078.24
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Rationale: Tracheostomized patients weaning from mechanical ventilation are at risk for dryness of airway mucosa and sputum accumulation during disconnection from mechanical ventilation. High-flow tracheal oxygen (HFTO) is being used as supportive therapy during disconnection sessions in tracheostomized patients weaning from invasive mechanical ventilation (IMV) to limit dryness while maintaining oxygenation. We recently summarized the studies comparing physiological effects HFTO as compared to other interfaces, collectively referred to as conventional oxygen therapy (COT), in a systematic review and identified areas of lacking knowledge: effect on sputum viscoelasticity, respiratory effort early in the weaning process and dyspnea sensation. We hypothesize that HFTO, compared to COT, decreases viscoelasticity of the sputum and provides respiratory support during weaning. This may improve weaning by facilitating clearance of airway mucus, preventing respiratory failure, and providing comfort by decreasing dyspnea. Objective: To determine the physiological effect of HFTO compared to COT on sputum viscoelasticity, respiratory effort and dyspnoea. Study design: Pilot study with randomized crossover design, single-center. Study population: Twenty adult patients weaning from mechanical ventilation with tracheostomy. Intervention (if applicable): Crossover with COT and HFTO during two days in the weaning phase. Main study parameters/endpoints: Primary endpoint: sputum viscoelasticity measured by rheology during long disconnection sessions in the final phase of weaning. Secondary endpoints: respiratory effect measured by swings in esophageal pressure (PES) and prevalence and severity of dyspnoea sensation by visual analogue scale (VAS). Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The study compares two therapeutic modalities both used in clinical care without side-effects or complications. Study procedures and measurements consist of standard clinical procedures that are performed daily in clinical setting with negligible risk of deterioration for the patient. During weaning with HFTO sputum clearance might be more easy for the patient and respiratory effort might decrease, both are assumed to be beneficial for the weaning process of the patient.

Conditions

Weaning from Mechanical Ventilation; Tracheostomy Weaning; Respiratory Failure

Keywords

weaning from mechanical ventilation; tracheostomy; high flow oxygen; airway mucus; respiratory effort; dyspnea

Outcome Measures

Primary Outcomes (1)

• Sputum viscoelasticity

  During disconnection from the ventilator patients do not breathe actively heated and humidified gas mixtures. During disconnection from the ventilator the airway mucus thickens. This thickening can be quantified by measuring visco-elasticity and at the end of the disconnection sessions. The change in visco-elasticity between the start and end of the disconnection session will be compared within patients between disconnection sessions with HME and HFTO. Hence, the primary end-point is the change in sputum viscoelasticity from baseline to the end of the long disconnection sessions (≥12 hours). Viscoelastic (G\*) is made up of elasticity (G') and viscosity (G'') of mucus at a 5% strain rate (or linear viscoelastic region, which reflects the small deformation regime) and the critical stress (σ critical)· and strain (y critical) of mucus, which reflect the behavior of mucus under high amounts of shear stress and thus the large deformation regime.

  The 12-hour disconnection session

Secondary Outcomes (4)

• Sputum visco-elasiticity

  The short disconnection session (<90 minutes)

• Dyspnea presence

  At early (<90 min) and late (12 hour) disconnection sessions

• Respiratory effort

  The short disconnection session (<90 minutes)

• Dyspnea severity

  early (<90 min) and late (12 hour) disconnection sessions

Study Arms (2)

First high-flow tracheal oxygen, then conventional oxygen therapy

ACTIVE COMPARATOR

The disconnection sessions on the days with study measurements are started with high-flow tracheal oxygen, and the second disconnection session is supported with conventional oxygen therapy. Conventional oxygen therapy is provided using a heat-moisture exchanger.

Device: Oxygen therapy

First conventional oxygen therapy, then high-flow tracheal oxygen

ACTIVE COMPARATOR

The disconnection sessions on the days with study measurements are started with conventional oxygen therapy, and the second disconnection session is supported with high-flow tracheal oxygen. Conventional oxygen therapy is provided using a heat-moisture exchanger.

Device: Oxygen therapy

Interventions

Oxygen therapy DEVICE

All patients are subject to both oxygen therapy groups in this randomized cross-over study. Study measurements are performed during several different disconnection sessions. Disconnection sessions can either be short (\<90 min) or long (12 hours). Both short and long disconnection sessions are performed twice; once with conventional oxygen, and once with high-flow tracheal oxygen as respiratory support.

First conventional oxygen therapy, then high-flow tracheal oxygen; First high-flow tracheal oxygen, then conventional oxygen therapy

Eligibility Criteria

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

You may qualify if:

• Age ≥18 years
• Weaning from mechanical ventilation with tracheostomy

You may not qualify if:

• Longstanding tracheostomy, defined as tracheostomy being present prior to current hospital admission
• Tracheostomy primarily indicated for chronic upper airway obstruction or to secure airway patency due to persistent stupor/coma
• Chronic positive pressure respiratory support at home (excluding night-time continuous positive airway pressure for sleep apnea)
• Mucociliary disease in medical history (e.g. cystic fibrosis, pulmonary ciliary dyskinesia)
• Neuromuscular disease in medical history (excluding ICU-acquired weakness)
• Contra-indication placement oesophageal balloon for measurement of PES, such as:
• Fractures in mandibular, orbital or ethmoid bone or skull base
• Esophageal varices or surgery in medical history
• Severe bleeding disorders
• Hemoptysis in 72 hours prior to the first disconnection session. Clinically relevant hemoptysis is defined as hemoptysis requiring tracheal/endobronchial or radiologic intervention, or administration of pro-coagulating drugs such as tranexamic acid.

Sponsors & Collaborators

• Henrik Endeman: lead
• Fisher and Paykel Healthcare: collaborator

Study Sites (1)

Erasmus Medical Center

Rotterdam, 3015, Netherlands

RECRUITING

MeSH Terms

Conditions

Respiratory Insufficiency; Dyspnea

Interventions

Oxygen Inhalation Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Respiratory Therapy; Therapeutics

Central Study Contacts

Thijs Janssen Resident pulmonology, Critical Care researcher, MD

CONTACT

0107035142; m.l.janssen@erasmusmc.nl

Henrik Endeman Intensivist, Assistant Professor Intensive Care, MD, PhD

CONTACT

0107035142; h.endeman@erasmusmc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Intensivist, Assistant professor Intensive Care

Study Record Dates

• First Submitted: January 10, 2025
• First Posted: January 15, 2025
• Study Start: January 6, 2025
• Primary Completion: January 31, 2025
• Study Completion (Estimated): July 1, 2026
• Last Updated: January 15, 2025

Record last verified: 2025-01

Locations

NL (1)