Clinical trial NCT06816745: Comparison of Physiological Effects of Two Types of High-Flow Oxygen Therapy in Tracheostomized Patients
Official title: Comparison of Physiological Effects of Standard and Modified High-Flow Oxygen Therapy in Tracheostomized Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Critical Care
Oxygen Therapy
Tracheostomy
Keywords: high-flow tracheal oxygen
tracheostomy
Lead sponsor: Capital Medical University
Sponsor class: OTHER
First posted: 2025-02-10
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Mean expiratory airway pressure
timeFrame: From enrollment to the end of treatment at 4 hours
measure: Positive end-expiratory pressure
timeFrame: From enrollment to the end of treatment at 4 hours
measure: Change of end-expiatory lung volume
timeFrame: From enrollment to the end of treatment at 4 hours
Secondary outcomes:
measure: Respiratory rate
timeFrame: From enrollment to the end of treatment at 4 hours
measure: Tidal volume
timeFrame: From enrollment to the end of treatment at 4 hours
measure: End-tidal carbon dioxide
timeFrame: From enrollment to the end of treatment at 4 hours
measure: Pulse oxygen saturation
timeFrame: From enrollment to the end of treatment at 4 hours
measure: Esophageal pressure-time product
timeFrame: From enrollment to the end of treatment at 4 hours
measure: Tidal swing of esophageal pressure
timeFrame: From enrollment to the end of treatment at 4 hours
measure: Respiratory muscle pressure
timeFrame: From enrollment to the end of treatment at 4 hours
measure: Dynamic transpulmonary pressure
timeFrame: From enrollment to the end of treatment at 4 hours
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Shijitan Hospital
state: Beijing
Study officials:
affiliation: Capital Medical University
name: Jian-Xin Zhou, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: