Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) and Short Laryngologic Surgery

Stanford University

Status: Completed

Conditions: Laryngologic Surgical Procedures

Treatments: Device: THRIVE; Device: Endotracheal tube

Study type: Interventional

Funder types: Other

Identifiers

NCT03091179

39202

Details and patient eligibility

About

The purpose of this study is to investigate whether selected, short laryngologic surgical procedures can be safely and potentially more effectively performed without the use of endotracheal tube or jet ventilation, under completely tubeless conditions. The patient's gas exchange will be supported by rapid insufflation of high-flow oxygen through specialized nasal cannulae: the so called Transnasal Humidified Rapid- Insufflation Ventilatory Exchange (THRIVE).

Enrollment: 20 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients presenting for short, non-laser laryngologic surgery

Exclusion criteria

1. Patients with significantly decreased myocardial function (ejection fraction < 50%)

2. Patients with abnormal cardiac rhythm and conduction abnormalities, except for patients with isolated, asymptomatic premature atrial and ventricular contractions.

3. Patients with significant peripheral vascular disease, such as those with the symptoms of intermittent claudication.

4. Patients with known significant cerebrovascular disease, such as history of cerebrovascular accidents (CVAs) and transient ischemic attacks (TIAs).

5. Patients with significant renal insufficiency, as manifested by estimated glomerular filtration rate (eGFR) < 60 ml/min/1.73 m2.

6. Patients with electrolyte (K+, Ca++) abnormalities, as determined by the lab values outside of a normal range.

7. Patients with the history or symptoms of increased intracranial pressure or reduced intracranial compliance (e.g. headaches, nausea and vomiting, visual changes, mental changes).

8. Patients with skull base defects.

9. Patients with pulmonary hypertension who have pulmonary artery pressures above the normal range.

10. Patients with significant chronic obstructive or restrictive lung diseases, as manifested by known history of baseline chronic hypoxia and/or hypercapnia, and/or baseline room air SpO2 < 95%.

11. Obese patients with BMI above 35 kg/m2.

12. Patients with severe and poorly controlled gastroesophageal reflux disease despite medical treatment.

13. Patients with hiatal hernia and full stomach patients. 15. Patient's refusal to participate in the study. 16. Patients who do not understand English or mentally handicapped. 17. Pregnant or breastfeeding patients.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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20 participants in 2 patient groups

THRIVE

Experimental group

Description:

high flow nasal oxygen

Treatment:

Device: THRIVE

Endotracheal tube

Active Comparator group

Description:

tracheal intubation

Treatment:

Device: Endotracheal tube