Comparison of Physiological Effects of Two Types of High-Flow Oxygen Therapy in Tracheostomized Patients

Not Applicable

Not yet recruiting

• Conditions: Oxygen Therapy; Tracheostomy; Critical Care

• Registration Number: NCT06816745
• Lead Sponsor: Jian-Xin Zhou

Brief Summary

High-flow nasal oxygen therapy offers benefits like precise oxygen delivery, flow-related positive end-expiratory pressure generation and improved lung function. High-flow oxygen therapy can be applied via tracheostomy as high-flow tracheal oxygen. While high-flow tracheal oxygen has been used to facilitate weaning, it has diminished physiological effects due to bypassing upper airways. To enhance its effectiveness, researchers developed a modified high-flow tracheal oxygen tube with a smaller expiratory end diameter to increase airway resistance and pressure. This is a prospective randomized crossover study that aims to compare the physiological effects of standard and modified high-flow oxygen therapy in tracheostomized patients.

Detailed Description

High-flow nasal oxygen therapy has been shown to provide several physiological benefits, including precise control of the fraction of inspired oxygen, generation of flow-related positive end-expiratory pressure, increased end-expiratory lung volume, improved oxygenation, and enhanced carbon dioxide elimination. It has been widely utilized in managing acute hypoxemic respiratory failure and preventing hypoxemia after extubation.

High-flow oxygen therapy can be applied via tracheostomy as high-flow tracheal oxygen. Previous studies have reported successful cases of using high-flow tracheal oxygen to facilitate weaning from prolonged mechanical ventilation in patients with restrictive and obstructive pulmonary disorders. However, compared to high-flow nasal oxygen, high-flow tracheal oxygen exhibits significantly diminished physiological effects due to the bypassing of the narrow nasopharynx, glottis, and upper airway, as well as a more open circuit.

To address this limitation, the investigators have developed a modified high-flow tracheal oxygen tube with a reduced expiratory end tube diameter. This modification aims to create higher expiratory resistance and airway pressure, thus simulating the physiological effects of high-flow nasal cannula. This is a prospective randomized crossover physiological trial designed to compare the effects of standard and modified high-flow oxygen therapy in tracheostomized patients. Key physiological parameters will be assessed, including airway pressure, end-expiratory lung volume, vital signs, oxygenation, and respiratory workload.

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-04
• Study First Submitted QC: 2025-02-06
• Last Update Submitted: 2025-02-06
• Study First Posted: 2025-02-10
• Last Update Posted: 2025-02-10
• Study Start: 2025-02-20
• Primary Completion: 2025-11-30
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Tracheostomy with stable spontaneous breathing.

Exclusion Criteria

1. Age younger than 18 years old
2. Pregnancy
3. Hemodynamic instability (mean arterial pressure <60 mmHg, heart rate >140 or <60 bpm)
4. Respiratory and oxygenation instability (respiratory rate > 35bpm or oxygen saturation measured by pulse oximetry <90%)
5. Neuromuscular diseases or phrenic nerve injury
6. Recent trauma or surgery to the trachea, esophagus, neck, chest, or stomach
7. Pneumothorax or placement of a chest drainage
8. Contraindication to electrical impedance tomography (EIT) (implantable defibrillator)
9. Anticipating withdrawal of life support

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Mean expiratory airway pressure	From enrollment to the end of treatment at 4 hours	Mean expiratory airway pressure will be measured during standard and modified high-flow tracheal oxygen.
Positive end-expiratory pressure	From enrollment to the end of treatment at 4 hours	Positive end-expiratory pressure will be measured during standard and modified high-flow tracheal oxygen.
Change of end-expiatory lung volume	From enrollment to the end of treatment at 4 hours	Change of end-expiatory lung volume will be measured during standard and modified high-flow tracheal oxygen.

Secondary Outcome Measures

Name	Time	Method
Respiratory rate	From enrollment to the end of treatment at 4 hours	Respiratory rate will be measured during standard and modified high-flow tracheal oxygen.
Esophageal pressure-time product	From enrollment to the end of treatment at 4 hours	Esophageal pressure-time product will be measured during standard and modified high-flow tracheal oxygen.
Tidal volume	From enrollment to the end of treatment at 4 hours	Tidal volume will be measured during standard and modified high-flow tracheal oxygen.
End-tidal carbon dioxide	From enrollment to the end of treatment at 4 hours	End-tidal carbon dioxide will be measured during standard and modified high-flow tracheal oxygen.
Respiratory muscle pressure	From enrollment to the end of treatment at 4 hours	Respiratory muscle pressure will be measured during standard and modified high-flow tracheal oxygen.
Tidal swing of esophageal pressure	From enrollment to the end of treatment at 4 hours	Tidal swing of esophageal pressure will be measured during standard and modified high-flow tracheal oxygen.
Pulse oxygen saturation	From enrollment to the end of treatment at 4 hours	Pulse oxygen saturation will be measured during standard and modified high-flow tracheal oxygen.
Dynamic transpulmonary pressure	From enrollment to the end of treatment at 4 hours	Dynamic transpulmonary pressure will be measured during standard and modified high-flow tracheal oxygen.

Trial Locations

Locations (1)

Beijing Shijitan Hospital; 🇨🇳 Beijing, Beijing, China