Comparison of Oxygenation Between Nasal PAP vs Nasal During Propofol-based Sedation for EUS

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-14

Study Completion Date

2022-03-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Randomized controlled single site study involves oxygenation, continuous positive airway pressure, and ventilation of subject via nasal mask and oxygenationvia closed facemask. The intervention of the study are delivery form of supplemental oxygen, bag-mask ventilation, and continuous nasal CPAP intraoperatively and in the post anesthesia care period.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Sedation Compaired With Anesthesia With THRIVE in Endotracheal Intubation With Difficult Airways

NCT04924621

Sedative, Hypnotic, or Anxiolytic Withdrawal Airway Control

UNKNOWN NA

A Study Evaluating Sedation of Intravenous Administration of HSK3486 Injectable Emulsion in ICU Patients Undergoing Mechanical Ventilation

NCT04620031

Sedation in Intensive Care

COMPLETED PHASE3

A Clinical Study Evaluating Sedation of Intravenous Administration of HSK3486 in ICU Patients Undergoing Long-Term Mechanical Ventilation

NCT04669821

Sedation in Intensive Care

COMPLETED PHASE2

A Study Comparing Sevoflurane and Propofol in Patients Undergoing Endobronchial Ultrasound Guided Needle Aspiration

NCT07338578

Hemodynamic Stability Pulmonary Diseases or Conditions Complication of Anesthesia

COMPLETED

Propofol Infusion-Based Sedation on Anesthesia-Related Adverse Events in Endoscopic Ultrasonography

NCT06389045

Sedation Complication Endoscopic Ultrasonography Procedural Sedation

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

124 patients with BMI\> or equal to 35kg.m2 or documented Obstructive Sleep Apnea scheduled for an EUS with Propofol sedation will be randomized to CPAP vs nasal mask for oxygenation during their procedure. Patients will be monitored every 2 minutes during the procedure and in the recovery area until discharge. If patients have difficulty or refuse to wear the mask, 2 or more simultaneous or non-synchronous adverse events, change in heart rhythm or ST changes on EKG they will immediately changed to the other group. The ansethesiologist, gastroenterologist \& patient will complete post-procedure questionnaires regarding their opinion of the oxygen delivery system.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Endoscopic Ultrasound

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Random assignment to oxygen delivery system: facial mask or SuperNO2VA Et. Crossover to other oxygen delivery system if patient experiences difficulty with assigned system.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Random assignment to oxygen delivery system: facial mask or SuperNO2VA Et. Crossover to other oxygen delivery system if patient experiences difficulty with assigned system.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Facial mask

facial mask for oxygen delivery

Group Type ACTIVE_COMPARATOR

SuperNO2VA

Intervention Type DEVICE

SUPERNO2VA is nasal PAP device for oxygen delivery

SuperNO2VA

SuperNO2VA is CPAP device to deliver oxygen with nasal mask rather than with facial mask

Group Type EXPERIMENTAL

SuperNO2VA

Intervention Type DEVICE

SUPERNO2VA is nasal PAP device for oxygen delivery

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

SuperNO2VA

SUPERNO2VA is nasal PAP device for oxygen delivery

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Age 18 years of age or older
2. Patients undergoing upper endoscopic ultrasound
3. American Society of Anesthesiology (ASA) Physical Status I-III
4. BMI ≥35 kg/m2 or documented Obstructive Sleep Apnea
5. Has provided written informed consent

Exclusion Criteria

1. Inpatient status
2. Active Congestive Heart Failure Exacerbation
3. Untreated ischemic heart disease
4. Acute exacerbation of respiratory disorders, including COPD and asthma
5. Emergent procedures
6. Pregnancy
7. Previous enrollment in this study
8. Inability to provide informed consent
9. Additional medical testing planned for the same day
10. History of allergic reaction to Propofol
11. Tracheostomy
12. Supra-glottic or sub-glottic tumor
13. Gastrointestinal tract obstruction or delayed transit (including delayed gastric emptying, gastric bezoar, achalasia, toxic megacolon).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No