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

Not Applicable

Completed

• Conditions: Laryngologic Surgical Procedures
• Interventions: Device: Endotracheal tube; Device: THRIVE

• Registration Number: NCT03091179
• Lead Sponsor: Stanford University

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-03-05
• Study Start: 2017-03-17
• Study First Submitted QC: 2017-03-21
• Study First Posted: 2017-03-27
• Primary Completion: 2018-07-18
• Study Completion: 2018-07-18
• Results First Submitted: 2019-06-21
• Results First Submitted QC: 2019-06-21
• Results First Posted: 2019-07-17
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-25
• Last Update Posted: 2020-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Endotracheal tube	Endotracheal tube	tracheal intubation
THRIVE	THRIVE	high flow nasal oxygen

Primary Outcome Measures

Name	Time	Method
Duration of Surgery (Primary Surgical Outcome)	intraoperative (up to one hour)
Suspension Time (Primary Surgical Outcome)	intraoperative (up to 5 min)	Time required for the surgeon to position the patient's head and expose the surgical field for surgery using operating laryngoscope
Number of Suspension Repositioning Maneuvers (Primary Surgical Outcome)	intraoperative (up to 5 min)	Number of attempts required for the surgeon to reposition the patient's head for optimal surgical exposure using operating laryngoscope
Time to Awakening From Anesthesia (Primary Anesthesia Outcome)	intraoperative (up to 20 min)	time from end of surgery to responding to commands/extubation
Average Oxygen Saturation by Pulse Oximetry (SpO2) (Primary Anesthesia Outcome)	intraoperative (up to one hour)

Secondary Outcome Measures

Name	Time	Method
Opioid Consumption	Recovery room admission and discharge (up to 2 hours)	Total oral opioid consumption in morphine milligram equivalents
Change in Voice Handicap Index (VHI)	Preoperative assessment and one month after surgery	numerical scale, range from 0 to 40, with higher scores corresponding to worse outcome
Alertness	Recovery room admission (up to 30 min following admission to recovery room)	Time required for the patient to become fully alert and oriented per standard recovery room evaluation
Quality of Recovery	One week after surgery	15-question survey, with each question scored from 0 to 10. Overall range 0-150, higher scores correspond to better outcome.
Numerical Pain Rating Scores	Recovery room admission and discharge (up to 2 hours)	A score from 0 to 10, higher scores corresponding to higher pain
Recovery Room Time	Up to 2 hours after procedure

Trial Locations

Locations (1)

Stanford Hospital and Clinics; 🇺🇸 Stanford, California, United States