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NCT Number: NCT03615417

High-Flow Nasal Cannula (HFNC) Preoxygenation in Obese Patients Undergoing General Anesthesia

This study aims to evaluate the effectiveness of the High Flow Nasal Cannula (HFNC) for the preoxygenation of obese patients undergoing a general anesthesia. The HFNC interface is compared to a standard anesthesia FaceMask (FM) preoxygenation with Continuous Positive Airway Pressure (CPAP), the current gold standard procedure for obese induction.

The interest of HFNC preoxygenation is to increase the "safe apnea time" before critical arterial desaturation, useful in the management of difficult airways, especially in subjects with reduced respiratory reserves such as the obese.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Erasme University Hospital

Brussels, 1070, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Surgery with the need for general anesthesia with muscle relaxation
  • ASA (American Society of Anesthesiologists) physical status score II-III
  • BMI > 35

Exclusion criteria

  • Severe respiratory disease (acute respiratory failure, Chronic obstructive pulmonary disease COPD, parenchymal pneumopathies,...)
  • Severe nasal pathology (malformation, stenosis)
  • Criteria or previous difficult intubation
  • BMI > 50
  • Chest circumference > 150cm
  • Implanted electronic device (pacemaker, neurostimulator, ...)
  • Pregnancy

Treatment and study plan

High flow nasal cannula (HFNC)

Device

Preoxygenation trough High Flow Nasal Cannula (HFNC) at 100% FiO2, 50 liters/min and closed mouth.

After Rapid Sequence Induction (RSI), maintenance of apnea with HFNC at 100% FiO2, 70 liters/min and jaw thrust.

At time of peripheral oxygen saturations (SpO2) decreases by 2% or after 10 minutes of apnea, the participant is intubated.

Other names: THRIVE, OptiFlow

Standard anesthesia FaceMask (FM)

Device

Preoxygenation trough standard anesthesia FaceMask (FM) at 100% FiO2, 12 liters/min, CPAP 7 cmH2O.

After Rapid Sequence Induction (RSI), maintenance of apnea without mask. At time of peripheral oxygen saturations (SpO2) decreases by 2% or after 10 minutes of apnea, the participant is intubated.

Primary outcomes

  1. Functional Residual Capacity (FRC) variation

    Time frame: 20 minutes

    The difference of FRC, estimated by lung Electrical Impedance Tomography (EIT), during general anesthesia induction (from a base period to the mechanical ventilation).

Secondary outcomes

  1. Time of safe apnea

    Time frame: 20 minutes

    The time (seconds) of apnea following preoxygenation and muscle relaxation before to peripheral oxygen saturations (SpO2) decreases by 2%, or the apnea time reaches 600 seconds.

  2. Lowest SpO2

    Time frame: 20 minutes

    The lowest SpO2 (%) during general anesthesia induction (from a base period to the mechanical ventilation).

  3. Preoxygenation Comfort

    Time frame: 6 hours

    The subjective comfort of the patient during the preoxygenation, expressed with a 0-5 scale at Post Anesthesia Care Unit (PACU) discharge.

Sponsors and collaborators

Lead sponsor

Erasme University Hospital

Other

Registry information

Official study title

Effectiveness of High-Flow Nasal Cannula (HFNC) Preoxygenation in Obese Patients Undergoing General Anesthesia: A Randomised Controlled Trial

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Aug 3, 2018
Registry last updated
Nov 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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