Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) and Laser Laryngeal Surgery

NCT ID: NCT03086265

Last Updated: 2020-03-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-24
• Study Completion Date: 2019-02-26

Brief 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).

Conditions

Otorhinolaryngologic Surgical Procedures; Laser Therapy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

THRIVE

high flow nasal oxygen

Group Type: EXPERIMENTAL

THRIVE

Intervention Type: DEVICE

active nasal oxygen delivery system

Endotracheal tube

tracheal intubation

Group Type: ACTIVE_COMPARATOR

Endotracheal tube

Intervention Type: DEVICE

Plastic tube for supporting ventilation during surgery

Interventions

THRIVE

active nasal oxygen delivery system

Intervention Type: DEVICE

Endotracheal tube

Plastic tube for supporting ventilation during surgery

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Vladimir Nekhendzy

Clinical Professor of Anesthesiology and Otolaryngology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Vladimir Nekhendzy, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford Hospital and Clinics

Stanford, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

36060

Identifier Type: -

Identifier Source: org_study_id