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

NCT ID: NCT06776939

Last Updated: 2025-01-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-06
• Study Completion Date: 2026-07-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

First high-flow tracheal oxygen, then conventional oxygen therapy

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.

Group Type: ACTIVE_COMPARATOR

Oxygen therapy

Intervention Type: 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

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.

Group Type: ACTIVE_COMPARATOR

Oxygen therapy

Intervention Type: 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.

Interventions

Oxygen therapy

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fisher and Paykel Healthcare

INDUSTRY

Sponsor Role: collaborator

Henrik Endeman

OTHER

Sponsor Role: lead

Responsible Party

Henrik Endeman

Intensivist, Assistant professor Intensive Care

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Erasmus Medical Center

Rotterdam, , Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

Thijs Janssen Resident pulmonology, Critical Care researcher, MD

Role: CONTACT

m.l.janssen@erasmusmc.nl

0107035142

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

Role: CONTACT

h.endeman@erasmusmc.nl

0107035142

Facility Contacts

Thijs Janssen, MD

Role: primary

m.l.janssen@erasmusmc.nl

010-7035142

Other Identifiers

NL87502.078.24

Identifier Type: OTHER

Identifier Source: secondary_id

MEC-2024-0468

Identifier Type: -

Identifier Source: org_study_id