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

NCT03009877 | Withdrawn FDA Device

• 1 other identifier: 2016-7360
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• Time to desaturation

  Intraoperatively, apneic time will be record from the time of administration of the muscle relaxant. The time until the first desaturation will be recorded. The maximum time of measurement will be 10 minutes.

  up to 10 minutes

Secondary Outcomes (2)

• Time until hypercarbia > 65 mmHg

  up to 10 minutes

• Assess correlation between end tidal CO2 and transcutaneous CO2 monitoring

  up to 10 minutes

Study Arms (2)

Preoxygenation with face mask

ACTIVE COMPARATOR

Standard preoxygenation with a mask will be performed for five minutes. Once preoxygenation is complete, patients will be induced with standard induction medications including lidocaine, midazolam, fentanyl and propofol. Once the patient is apneic, one breath will be given via facemask to confirm ventilation and then 0.6 mg/kg of rocuronium will be administered. The 5.5mm flexible intubation scope will be introduced into the oropharynx and advanced into the trachea with the assistance of the C-MAC video laryngoscope. Once the flexible intubation scope is in the trachea, the endotracheal tube (7.0 mm unless otherwise specified) will be advanced. Ventilation will not begin until the primary or secondary endpoints are reached.

Device: facemask; Drug: Rocuronium; Drug: Propofol; Drug: Fentanyl; Drug: Midazolam; Device: C-MAC Premium Video Intubation Platform-KARL STORZ

Preoxygenation via hi flow nasal cannula

EXPERIMENTAL

The high flow nasal cannula (Optiflow) will be applied as soon as the patient is in the operating room. The patient will be preoxygenated with high flow nasal cannula at 50 L/min for 5 minutes. After induction, general anesthesia will be maintained with a propofol infusion. One breath will be given via facemask to confirm ventilation and then 0.6 mg/kg of rocuronium will be administered. Upon apnea, the Optiflow™ flow will be increased to 70 L/min and jaw thrust will be performed until the patient is adequately relaxed. The video laryngoscope (C-MAC) will then be introduced into the oropharynx and the flexible intubation scope advanced into the trachea with the assistance of the C-MAC. Once the flexible intubation scope is in the trachea, the endotracheal tube will be advanced.

Device: Optiflow F&P 850™ System; Drug: Rocuronium; Drug: Propofol; Drug: Fentanyl; Drug: Midazolam; Device: C-MAC Premium Video Intubation Platform-KARL STORZ

Interventions

Optiflow F&P 850™ System DEVICE

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.

Also known as: High flow nasal cannula

Preoxygenation via hi flow nasal cannula

facemask DEVICE

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

Also known as: face mask

Preoxygenation with face mask

Rocuronium DRUG

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

Preoxygenation via hi flow nasal cannula; Preoxygenation with face mask

Propofol DRUG

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

Preoxygenation via hi flow nasal cannula; Preoxygenation with face mask

Fentanyl DRUG

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

Preoxygenation via hi flow nasal cannula; Preoxygenation with face mask

Midazolam DRUG

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

Also known as: Versed

Preoxygenation via hi flow nasal cannula; Preoxygenation with face mask

C-MAC Premium Video Intubation Platform-KARL STORZ DEVICE

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).

Also known as: videolaryngoscope and optical fiberoptic bronchoscope

Preoxygenation via hi flow nasal cannula; Preoxygenation with face mask

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients (≥ 18 years old) undergoing elective surgery requiring general anesthesia
• BMI \> 40 kg/m2
• American Society of Anesthesiology (ASA) Physical Status II-III

You may not qualify if:

• Chronic hypoxemia (SpO2 \<94% on room air or on home oxygen)
• Acute respiratory failure
• Coronary artery disease and/or congestive heart failure
• Moderate-Severe pulmonary hypertension and/or RV dysfunction
• Full stomach (recently eaten)
• Pregnancy
• Chronic pulmonary disease (specifically COPD or interstitial disease, NOT asthma)
• Respiratory tract pathology
• Facial Abnormality
• American Society of Anesthesiology (ASA) Physical Status IV-V

Sponsors & Collaborators

• Montefiore Medical Center: lead
• The University of Texas Health Science Center, Houston: collaborator
• M.D. Anderson Cancer Center: collaborator

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MeSH Terms

Conditions

Obesity, Morbid

Interventions

Masks; Rocuronium; Propofol; Fentanyl; Midazolam

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Surgical Attire; Equipment and Supplies, Hospital; Equipment and Supplies; Protective Devices; Personal Protective Equipment; Surgical Equipment; Manufactured Materials; Technology, Industry, and Agriculture; Androstanols; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Irene Osborn, MD

  Montefiore Medical Center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-principal investigator, Attending Anesthesiologist

Study Record Dates

• First Submitted: December 21, 2016
• First Posted: January 4, 2017
• Study Start: July 1, 2018
• Primary Completion: May 1, 2019
• Study Completion: December 1, 2019
• Last Updated: March 27, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will share