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Apneic Oxygenation With a Nasal Cannula in the Obese and Morbidly Obese Surgical Patient

The University of Texas System (UT) logo

The University of Texas System (UT)

Status

Completed

Conditions

Apneic; Oxygenation

Treatments

Other: Air
Other: Oxygen

Study type

Interventional

Funder types

Other

Identifiers

NCT03671837
STU 022017-074

Details and patient eligibility

About

This prospective, randomized, double-blind study is intended to enroll a total of 100 patients with a BMI ≥ 40 kg/m2 and another 100 patients with a BMI ≥ 30 kg/m2 (but less than 40 kg/m2) undergoing surgery with general endotracheal anesthesia at Parkland Hospital. Patients will be randomized to receive either 15 L/min O2 or 15 L/min air from a standard nasal cannula during a simulated prolonged laryngoscopy. The anesthesia provider will do a direct laryngoscopy to ensure that the patient has a Cormack-Lehane grade I-II airway. Patients who have grade III-IV airways will be excluded from further study procedures and not analyzed. The rest of the anesthetic will not deviate from the standard of care. Anesthesia providers will be blinded as to whether patients are receiving oxygen or air during the apneic period.

Enrollment

135 patients

Sex

All

Ages

18 to 80 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • 18-80 years old
  • Obesity (BMI ≥ 30 kg/m2 ≤ 40 kg/m2)
  • Morbid obesity (BMI ≥ 40 kg/m2)
  • Scheduled for a non-emergent operation that requires general endotracheal anesthesia
  • Willing and able to consent in English or Spanish
  • No current history of advanced pulmonary or cardiovascular disease

Exclusion criteria

  • Age less than 18 or older than 70
  • BMI < 30 kg/m2
  • Patient does not speak English or Spanish
  • Family or personal history of malignant hyperthermia
  • Patient refusal
  • Monitored anesthesia care (MAC) or regional anesthesia planned
  • Pregnant or nursing women
  • "Stat" (emergent) cases
  • Moderate to severe pulmonary disease (e.g., asthma, COPD, pulmonary fibrosis, pulmonary hypertension)
  • Respiratory infection within the past 14 days (e.g., pneumonia, bronchitis)
  • SpO2 < 97% on room air
  • Moderate to severe cardiac disease (e.g., CHF, CAD, aortic stenosis)
  • Severe gastroesophageal reflux disease (GERD)
  • Nasal obstruction (e.g., tumor)
  • Elevated intracranial pressure (e.g., brain tumor)
  • History of difficult airway

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

135 participants in 2 patient groups

Oyxgen
Experimental group
Description:
Nasal Insufflation with 15 L/min O2 and a nasopharyngeal airway
Treatment:
Other: Oxygen
Air
Active Comparator group
Description:
Nasal Insufflation with 15 L/min air and a nasopharyngeal airway
Treatment:
Other: Air

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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