N/A
N=20
Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) and Laser Laryngeal Surgery
Otorhinolaryngologic Surgical Procedures · Laser Therapy
Bottom Line
View on ClinicalTrials.gov: NCT03086265 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Mar 2020
Primary outcome: Primary: Lowest Intraoperative Peripheral Oxygen Saturation (SpO2) — 97; 97 percentage of oxygen — p=0.7934
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
- Feb 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Lowest Intraoperative Peripheral Oxygen Saturation (SpO2) |
97; 97 | 0.7934 |
| PRIMARY Partial Pressure of Oxygen in the Arterial Blood (PaO2) |
365; 294; 279; 245; 223; 251 | — |
| PRIMARY Partial Pressure of Carbon Dioxide in the Arterial Blood (PaCO2) |
32; 54; 65; 77; 86; 71 | — |
| PRIMARY pH in Blood |
7.4; 7.2; 7.2; 7.1; 7.1; 7.4 | — |
| PRIMARY Heart Rate |
65; 70; 72; 81; 79; 79 | — |
| PRIMARY Mean Arterial Pressure (MAP) |
90; 92; 78; 76; 71; 83 | — |
| PRIMARY Stroke Volume Index (SVI) |
50; 48; 45; 36; 48; 35 | — |
| PRIMARY Cardiac Index (CI) |
3.2; 3.4; 3.2; 3.0; 3.7; 2.8 | — |
| PRIMARY Systemic Vascular Resistance Index (SVRI) |
2249; 2140; 1769; 2026; 1341; 2182 | — |
| PRIMARY Awakening/Extubation Time |
14; 13 | 0.6876 |
| PRIMARY Time to Suspension |
4; 3 | 0.7549 |
| PRIMARY Number of Suspension Adjustments |
1; 2 | 0.6479 |
| PRIMARY Duration of Surgery |
61; 57 | 0.8322 |
| SECONDARY Count of Participants Requiring Jet Ventilation |
7; 0 | — |
| SECONDARY Time to Spontaneous Ventilation |
5; 11 | 0.0058 sig |
| SECONDARY Apnea Time |
70; 87 | 0.3346 |
| SECONDARY Duration of Anesthesia |
78; 89 | 0.5513 |
| SECONDARY Total Propofol Dose (Anesthetic) |
730; 920 | 0.1927 |
| SECONDARY Total Remifentanil Dose (Anesthetic) |
996; 1114 | 0.6483 |
| SECONDARY Total Phenylephrine Dose (Vasoactive Drug) |
300; 479 | 0.5625 |
| SECONDARY Total Ephedrine Dose (Vasoactive Drug) |
4; 1 | 0.2827 |
| SECONDARY Total Labetalol Dose (Vasoactive Drug) |
15; 13 | 0.8426 |
| SECONDARY Time to Patient Being Alert and Oriented x 4 |
23; 23 | 0.9856 |
| SECONDARY Recovery Room Discharge-ready Time |
64; 62 | 0.8112 |
| SECONDARY First Pain Score in Recovery Room |
2; 3 | 0.6587 |
| SECONDARY Pain Score at Discharge From Recovery Room |
3; 2 | 0.4143 |
| SECONDARY Analgesic Consumption |
12; 8 | 0.4324 |
| SECONDARY Quality of Recovery (QoR)15 Score |
135; 138; 146; 136 | 0.7221 |
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).
Eligibility Criteria
Inclusion Criteria
- Patients presenting for laser laryngeal surgery
Exclusion Criteria
- Patients with significantly decreased myocardial function (ejection fraction 35 kg/m2.
- Patients with severe and poorly controlled gastroesophageal reflux disease despite medical treatment.
- Patients with hiatal hernia and full stomach patients.
- Patient's refusal to participate in the study.
- Patients who do not understand English or mentally handicapped. Pregnant or breastfeeding patients.
Data sourced from ClinicalTrials.gov (NCT03086265). 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.