N/A
N=20
Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) and Short Laryngologic Surgery
Laryngologic Surgical Procedures
Bottom Line
View on ClinicalTrials.gov: NCT03091179 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Jul 2019
Primary outcome: Primary: Average Oxygen Saturation by Pulse Oximetry (SpO2) (Primary Anesthesia Outcome) — 93; 98.7 percentage of saturation (SpO2) — p=0.006
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- THRIVE (Device); Endotracheal tube (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Stanford University
- Primary completion
- Jul 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Average Oxygen Saturation by Pulse Oximetry (SpO2) (Primary Anesthesia Outcome) |
93; 98.7 | 0.006 sig |
| PRIMARY Time to Awakening From Anesthesia (Primary Anesthesia Outcome) |
10.3; 9.4 | — |
| PRIMARY Suspension Time (Primary Surgical Outcome) |
1.8; 4.3 | — |
| PRIMARY Number of Suspension Repositioning Maneuvers (Primary Surgical Outcome) |
0.4; 1.7 | — |
| PRIMARY Duration of Surgery (Primary Surgical Outcome) |
19.1; 20.9 | — |
| SECONDARY Alertness |
4.3; 4.8 | — |
| SECONDARY Recovery Room Time |
65.7; 77.7 | — |
| SECONDARY Numerical Pain Rating Scores |
1.3; 3.7; 0.9; 2.7 | — |
| SECONDARY Opioid Consumption |
8.8; 22.5 | — |
| SECONDARY Change in Voice Handicap Index (VHI) |
12.8; 22.7; 7.6; 13.6 | — |
| SECONDARY Quality of Recovery |
142.5; 131.2 | — |
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).
Eligibility Criteria
Inclusion Criteria
- Patients presenting for short, non-laser laryngologic surgery
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.
- Patients with pulmonary hypertension who have pulmonary artery pressures above the normal range.
- 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%.
- Obese patients with BMI above 35 kg/m2.
- Patients with severe and poorly controlled gastroesophageal reflux disease despite medical treatment.
- 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.
Data sourced from ClinicalTrials.gov (NCT03091179). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.