CompletedNot Applicable

Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) and Laser Laryngeal Surgery

United States20 participantsStarted 2017-03-24

Plain-language summary

The purpose of this study is to investigate whether laser laryngeal surgery can be safely and potentially more effectively performed without the use of tracheal intubation 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 cannula: the so called Transnasal Humidified Rapid- Insufflation Ventilatory Exchange (THRIVE).

Who can participate

Age range18 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

✕. Patients with significantly decreased myocardial function (ejection fraction \< 50%)
✕. Patients with abnormal cardiac rhythm and conduction abnormalities, except for patients with isolated, asymptomatic premature atrial and ventricular contractions.
✕. Patients with significant peripheral vascular disease, such as those with the symptoms of intermittent claudication.
✕. Patients with known significant cerebrovascular disease, such as history of cerebrovascular accidents (CVAs) and transient ischemic attacks (TIAs) .
✕. Patients with significant renal insufficiency, as manifested by estimated glomerular filtration rate (eGFR) \< 60 ml/min/1.73 m2.
✕. Patients with electrolyte (K+, Ca++) abnormalities, as determined by the lab values outside of a normal range.
✕. Patients with the history or symptoms of increased intracranial pressure or reduced intracranial compliance (e.g. headaches, nausea and vomiting, visual changes, mental changes).
✕. Patients with skull base defects.

What they're measuring

Lowest Intraoperative Peripheral Oxygen Saturation (SpO2)

Timeframe: Duration of surgery (average approximately 1 hour)

Partial Pressure of Oxygen in the Arterial Blood (PaO2)

Timeframe: Induction, 10, 20, 30, 40m following induction, spontaneous ventilation (approximately 1 hour), recovery room (approximately 1 hour)

Partial Pressure of Carbon Dioxide in the Arterial Blood (PaCO2)

Timeframe: Induction, 10, 20, 30, 40m following induction, spontaneous ventilation (approximately 1 hour), recovery room (approximately 1 hour)

pH in Blood

Timeframe: Induction, 10, 20, 30, 40m following induction, spontaneous ventilation (approximately 1 hour), recovery room (approximately 1 hour)

Heart Rate

Timeframe: Induction, 10, 20, 30, 40m following induction, spontaneous ventilation (approximately 1 hour)

Mean Arterial Pressure (MAP)

Timeframe: Induction, 10, 20, 30, 40m following induction, spontaneous ventilation (approximately 1 hour)

Stroke Volume Index (SVI)

Timeframe: Induction, 10, 20, 30, 40m following induction, spontaneous ventilation (approximately 1 hour)

Trial details

NCT IDNCT03086265

SponsorStanford University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-02-26

Results submitted2020-02-25

View on ClinicalTrials.gov More Otorhinolaryngologic Surgical Procedures trials

Plain-language summary

Who can participate

Age range18 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

✕. Patients with significantly decreased myocardial function (ejection fraction \< 50%)
✕. Patients with abnormal cardiac rhythm and conduction abnormalities, except for patients with isolated, asymptomatic premature atrial and ventricular contractions.
✕. Patients with significant peripheral vascular disease, such as those with the symptoms of intermittent claudication.
✕. Patients with known significant cerebrovascular disease, such as history of cerebrovascular accidents (CVAs) and transient ischemic attacks (TIAs) .
✕. Patients with significant renal insufficiency, as manifested by estimated glomerular filtration rate (eGFR) \< 60 ml/min/1.73 m2.
✕. Patients with electrolyte (K+, Ca++) abnormalities, as determined by the lab values outside of a normal range.
✕. Patients with the history or symptoms of increased intracranial pressure or reduced intracranial compliance (e.g. headaches, nausea and vomiting, visual changes, mental changes).
✕. Patients with skull base defects.

What they're measuring

Lowest Intraoperative Peripheral Oxygen Saturation (SpO2)

Timeframe: Duration of surgery (average approximately 1 hour)

Partial Pressure of Oxygen in the Arterial Blood (PaO2)

Timeframe: Induction, 10, 20, 30, 40m following induction, spontaneous ventilation (approximately 1 hour), recovery room (approximately 1 hour)

Partial Pressure of Carbon Dioxide in the Arterial Blood (PaCO2)

Timeframe: Induction, 10, 20, 30, 40m following induction, spontaneous ventilation (approximately 1 hour), recovery room (approximately 1 hour)

pH in Blood

Timeframe: Induction, 10, 20, 30, 40m following induction, spontaneous ventilation (approximately 1 hour), recovery room (approximately 1 hour)

Heart Rate

Timeframe: Induction, 10, 20, 30, 40m following induction, spontaneous ventilation (approximately 1 hour)

Mean Arterial Pressure (MAP)

Timeframe: Induction, 10, 20, 30, 40m following induction, spontaneous ventilation (approximately 1 hour)

Stroke Volume Index (SVI)

Timeframe: Induction, 10, 20, 30, 40m following induction, spontaneous ventilation (approximately 1 hour)