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NCT Number: NCT03671837

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

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.

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Key information

Conditions

Apneic; Oxygenation Apnea Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Parkland Health & Hospital System

Dallas, Texas, 75235, United States

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Oxygen

Other

15 L/min O2

Air

Other

15 L/min air

Primary outcomes

  1. Apneic Time

    Time frame: Intraoperative

    To determine whether apneic oxygenation via nasal cannula oxygen results in a longer period of apnea (SpO2 ≥ 95%) during a simulated prolonged laryngoscopy in obese and morbidly obese patients.

Secondary outcomes

  1. Resaturation Time

    Time frame: Intraoperative

    To determine the influence of apneic oxygenation via nasal cannula on the time for resaturation in obese and morbidly obese patients.

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Registry information

Official study title

Apneic Oxygenation With a Nasal Cannula in the Obese and Morbidly Obese Surgical Patient: A Randomized, Double-Blinded, Placebo-Controlled Trial

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Sep 14, 2018
Registry last updated
Mar 11, 2020

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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