Preoxygenation With Optiflow™ in Morbidly Obese Patients is Superior to Face Mask

NCT03009877 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2018-03-27

No results posted yet for this study

Summary

Optiflow™ may provide an opportunity to prolong apnea time in the morbidly obese patient population. This study will examine whether Optiflow can do this, and compare the pre-oxygenation with Optiflow to the pre-oxygenation achieved with face mask.

Conditions

  • Obesity, Morbid

Interventions

DEVICE

Optiflow F&P 850™ System

Optiflow™ (Fisher \& Paykel Healthcare Limited, East Tamaki, Auckland-New Zealand) offers the ability to comfortably deliver a complete range of oxygen concentrations and flows to extend the traditional boundaries of oxygen therapy. This will be placed on the patient immediately upon entering the operating room for 5 minutes, at 50 liters per minute then increased to 70 liters per minute after induction.

DEVICE

facemask

We will apply the facemask to the patient immediately upon entering the operating room to pre-oxygenate for five minutes.

DRUG

Rocuronium

Rocuronium will be administered after the ability to mask ventilate is determined.

DRUG

Propofol

Propofol infusion 50 micrograms to 150 micrograms will be administered immediately on induction to maintain sedation throughout apneic oxygenation.

DRUG

Fentanyl

Fentanyl will be administered at the beginning of induction, 2 micrograms per kilogram.

DRUG

Midazolam

midazolam will be given upon induction, 1-2 milligrams at the anesthesiologist's discretion.

DEVICE

C-MAC Premium Video Intubation Platform-KARL STORZ

After patient is induced, the 5.5mm flexible intubation video scope (C-MAC Premium Video Intubation Platform-KARL STORZ) will then be introduced into the oropharynx and advanced into the trachea with the assistance of the C-MAC video laryngoscope (3 or 4 blade based on anesthesiologist's discretion).

Sponsors & Collaborators

  • The University of Texas Health Science Center, Houston

    collaborator OTHER
  • M.D. Anderson Cancer Center

    collaborator OTHER
  • Montefiore Medical Center

    lead OTHER

Principal Investigators

  • Irene Osborn, MD · Montefiore Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-07-31
Primary Completion
2019-05-31
Completion
2019-12-31
FDA Device
Yes

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03009877 on ClinicalTrials.gov