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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03086265
Other study ID # 36060
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 24, 2017
Est. completion date February 26, 2019

Study information

Verified date March 2020
Source Stanford University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date February 26, 2019
Est. primary completion date February 26, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- Patients presenting for laser laryngeal 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 oxygen saturation (SpO2) < 95% .

11. Obese patients with BMI > 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.

14. Patient's refusal to participate in the study.

15. Patients who do not understand English or mentally handicapped. Pregnant or breastfeeding patients.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
THRIVE
active nasal oxygen delivery system
Endotracheal tube
Plastic tube for supporting ventilation during surgery

Locations

Country Name City State
United States Stanford Hospital and Clinics Stanford California

Sponsors (1)

Lead Sponsor Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Lowest Intraoperative Peripheral Oxygen Saturation (SpO2) Peripheral oxygen saturation is an estimate of the amount of oxygen in the blood. Duration of surgery (average approximately 1 hour)
Primary Partial Pressure of Oxygen in the Arterial Blood (PaO2) Induction, 10, 20, 30, 40m following induction, spontaneous ventilation (approximately 1 hour), recovery room (approximately 1 hour)
Primary Partial Pressure of Carbon Dioxide in the Arterial Blood (PaCO2) Induction, 10, 20, 30, 40m following induction, spontaneous ventilation (approximately 1 hour), recovery room (approximately 1 hour)
Primary pH in Blood The pH range is 0 to 14, with 7 being neutral. A pH of less than 7 indicate acidity, whereas a pH of greater than 7 indicates a base. Induction, 10, 20, 30, 40m following induction, spontaneous ventilation (approximately 1 hour), recovery room (approximately 1 hour)
Primary Heart Rate Induction, 10, 20, 30, 40m following induction, spontaneous ventilation (approximately 1 hour)
Primary Mean Arterial Pressure (MAP) Induction, 10, 20, 30, 40m following induction, spontaneous ventilation (approximately 1 hour)
Primary Stroke Volume Index (SVI) Stroke volume - the volume of blood ejected from a ventricle at each beat of the heart, equal to the difference between the end-diastolic volume and the end-systolic volume. The stroke volume index is a method of relating the stroke volume to the size of the person by dividing the stroke volume by the body surface area (BSA) (m^2). Induction, 10, 20, 30, 40m following induction, spontaneous ventilation (approximately 1 hour)
Primary Cardiac Index (CI) Cardiac index: A cardiodynamic measure based on the cardiac output, which is the amount of blood the left ventricle ejects into the systemic circulation in one minute, measured in liters per minute (l/min). Cardiac output is indexed to a patient's body size by dividing by the body surface area (m^2) to yield the cardiac index. Induction, 10, 20, 30, 40m following induction, spontaneous ventilation (approximately 1 hour)
Primary Systemic Vascular Resistance Index (SVRI) SVRI equals systemic vascular resistance (SVR) times BSA. SVR is the resistance to blood flow through the systemic circulation and it was measured in Wood units. Wood unit =80 dyne*seconds per centimetre^5 (dyne*sec/cm^5). Induction, 10, 20, 30, 40m following induction, spontaneous ventilation (approximately 1 hour)
Primary Awakening/Extubation Time Recorded from the end of surgery until the return of patient's protective airway reflexes and patient opening eyes to command. Duration of surgery (average approximately 1 hour)
Primary Time to Suspension Recorded from the moment of the introduction of the operating laryngoscope in patient's mouth to full surgical suspension. Duration of surgery (average approximately 1 hour)
Primary Number of Suspension Adjustments Number of adjustments of the suspension laryngoscope. Duration of surgery (average approximately 1 hour)
Primary Duration of Surgery Recorded from the moment of the introduction of the operating laryngoscope in patient's mouth to withdrawing the laryngoscope at the completion of surgery. Duration of surgery (average approximately 1 hour)
Secondary Count of Participants Requiring Jet Ventilation Jet ventilation refers to delivery of oxygen via high pressure jet ventilator. Duration of surgery (average approximately 1 hour)
Secondary Time to Spontaneous Ventilation Recorded from the discontinuation of anesthetic drugs to the return of patient's spontaneous ventilation. Duration of surgery (average approximately 1 hour)
Secondary Apnea Time Recorded from induction of anesthesia to the return of spontaneous ventilation. Duration of surgery (average approximately 1 hour)
Secondary Duration of Anesthesia Recorded from induction of anesthesia to patient's awakening/extubation Duration of surgery (average approximately 1 hour)
Secondary Total Propofol Dose (Anesthetic) Duration of surgery (average approximately 1 hour)
Secondary Total Remifentanil Dose (Anesthetic) Duration of surgery (average approximately 1 hour)
Secondary Total Phenylephrine Dose (Vasoactive Drug) Duration of surgery (average approximately 1 hour)
Secondary Total Ephedrine Dose (Vasoactive Drug) Duration of surgery (average approximately 1 hour)
Secondary Total Labetalol Dose (Vasoactive Drug) Duration of surgery (average approximately 1 hour)
Secondary Time to Patient Being Alert and Oriented x 4 Recorded from patient's admission to the recovery room to patient's orientation to person, place, time, and situation as assessed by the recovery room nurse. Duration of surgery (average approximately 1 hour)
Secondary Recovery Room Discharge-ready Time From admission to recovery room, to discharge from recovery room Duration of recovery room stay (average approximately 1 hour)
Secondary First Pain Score in Recovery Room Pain scale was 0-10 (0 = no pain, 10 - worst pain imaginable). Duration of recovery room stay (average approximately 1 hour)
Secondary Pain Score at Discharge From Recovery Room Pain scale was 0-10 (0 = no pain, 10 - worst pain imaginable). Duration of recovery room stay (average approximately 1 hour)
Secondary Analgesic Consumption Analgesic consumption was measured in oral morphine milligram equivalents (MME) Recovery room to 7th postoperative day
Secondary Quality of Recovery (QoR)15 Score The QoR15 has 15 questions each is on a scale of 0-10 to measure patient functionality. Scores are summed for an overall range of 0-150, with higher scores corresponding to better recovery. Prior to procedure, and 1-2 hours after procedure
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