The availability study of tissue oxygenation monitor in pharyngeal and tracheal mucosa

JRCT ID: jRCTs042220151

Registered date:01/03/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Cancer or severe aspiration condition requiring total laryngectomy
• Date of first enrollment: 04/04/2023
• Target sample size: 20
• Study type: Interventional

Intervention(s)

Measuring the tissue oxygen saturation of the pharyngeal and tracheal mucosa using a
tissue oxygen saturation monitor during laryngectomy and pharyngeal suture/permanent tracheostomy

Outcome(s)

• Primary Outcome: Comprehensive determination of the presence or absence of acquisition values of tissue oxygen saturation of normal mucosa away from the wound.

Secondary Outcome

1.Results of using Tokkale
2.Presence or absence of suture failure
3.Presence or absence of tracheal necrosis
4.Presence or absence of preoperative irradiation

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. Patients scheduled for palliative or radical surgery for total laryngectomy*
2. If due to cancer, the primary site is irrelevant
3. If due to cancer, any tissue type
4. Patients who gave written informed consent before enrollment
5. Aged 18 or older at the time of obtaining consent

* Including total laryngectomy to prevent aspiration due to severe aspiration

Exclude criteria

1. Patients who cannot be closed with pharyngeal mucosal suture alone and will require a free flap
2.Uncontrolled diabetes mellitus
3. Unstable angina pectoris (angina pectoris with onset or exacerbation within the last 3 weeks) or history of myocardial infarction within 6 months.
4.Poorly controlled hypertension as a complication.
5.Receiving continuous systemic (oral or intravenous) steroids or other immunosuppressants
6. SPO2<90% at enrollment
7. Severe occlusive vasculopathy
8. Complications with other cancers requiring simultaneous surgery
9.In addition, patients who are considered inappropriate as subjects of this study by the judgment of the doctor

Related Information

• Primary Sponsor: Mukaigawa Takashi