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

Jian-Xin Zhou

Status: Not yet enrolling

Conditions: Critical Care; Oxygen Therapy; Tracheostomy

Treatments: Procedure: Standard high flow tracheal oxygen; Procedure: Modified high flow tracheal oxygen

Study type: Interventional

Funder types: Other

Identifiers

NCT06816745

IIT2024-158-002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Modified high flow tracheal oxygen

Experimental group

Description:

Modified high-flow tracheal oxygen with flow rates of 40L/ min and 60L/min will be performed in tracheostomized patients.

Treatment:

Procedure: Modified high flow tracheal oxygen

Standard high flow tracheal oxygen

Experimental group

Description:

Standard high-flow tracheal oxygen with flow rates of 40 L/min and 60 L/min will be performed in tracheostomized patients.

Treatment:

Procedure: Standard high flow tracheal oxygen