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

NCT03091179 | Completed Results FDA Device

• 1 other identifier: 39202
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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).

Conditions

Laryngologic Surgical Procedures

Keywords

airway management; high flow nasal oxygen; high flow nasal cannula; THRIVE

Outcome Measures

Primary Outcomes (5)

• Average Oxygen Saturation by Pulse Oximetry (SpO2) (Primary Anesthesia Outcome)

  intraoperative (up to one hour)

• Time to Awakening From Anesthesia (Primary Anesthesia Outcome)

  time from end of surgery to responding to commands/extubation

  intraoperative (up to 20 min)

• Suspension Time (Primary Surgical Outcome)

  Time required for the surgeon to position the patient's head and expose the surgical field for surgery using operating laryngoscope

  intraoperative (up to 5 min)

• Number of Suspension Repositioning Maneuvers (Primary Surgical Outcome)

  Number of attempts required for the surgeon to reposition the patient's head for optimal surgical exposure using operating laryngoscope

  intraoperative (up to 5 min)

• Duration of Surgery (Primary Surgical Outcome)

  intraoperative (up to one hour)

Secondary Outcomes (6)

• Alertness

  Recovery room admission (up to 30 min following admission to recovery room)

• Recovery Room Time

  Up to 2 hours after procedure

• Numerical Pain Rating Scores

  Recovery room admission and discharge (up to 2 hours)

• Opioid Consumption

  Recovery room admission and discharge (up to 2 hours)

• Change in Voice Handicap Index (VHI)

  Preoperative assessment and one month after surgery

Study Arms (2)

THRIVE

EXPERIMENTAL

high flow nasal oxygen

Device: THRIVE

Endotracheal tube

ACTIVE COMPARATOR

tracheal intubation

Device: Endotracheal tube

Interventions

THRIVE DEVICE

active nasal oxygen delivery system

THRIVE

Endotracheal tube DEVICE

a plastic tube for mechanical ventilation

Endotracheal tube

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients presenting for short, non-laser laryngologic surgery

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford Hospital and Clinics

Stanford, California, 94305, United States

Location

Related Publications (1)

• Nekhendzy V, Saxena A, Mittal B, Sun E, Sung K, Dewan K, Damrose EJ. The Safety and Efficacy of Transnasal Humidified Rapid-Insufflation Ventilatory Exchange for Laryngologic Surgery. Laryngoscope. 2020 Dec;130(12):E874-E881. doi: 10.1002/lary.28562. Epub 2020 Feb 20.

  PMID: 32078170 RESULT

MeSH Terms

Interventions

Tobacco Use Cessation Devices

Intervention Hierarchy (Ancestors)

Therapeutics

Results Point of Contact

• Title: Vladimir Nekhendzy
• Organization: Stanford University

nek@stanford.edu

650-498-4055

Study Officials

• Vladimir Nekhendzy, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor of Anesthesiology and Otolaryngology

Study Record Dates

• First Submitted: March 5, 2017
• First Posted: March 27, 2017
• Study Start: March 17, 2017
• Primary Completion: July 18, 2018
• Study Completion: July 18, 2018
• Last Updated: March 4, 2020
• Results First Posted: July 17, 2019

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)