NCT03671837

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
135

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 12, 2017

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 14, 2018

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

March 11, 2020

Status Verified

March 1, 2020

Enrollment Period

2.5 years

First QC Date

September 12, 2018

Last Update Submit

March 10, 2020

Conditions

Apneic; Oxygenation

Outcome Measures

Primary Outcomes (1)

  • Apneic Time

    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.

    Intraoperative

Secondary Outcomes (1)

  • Resaturation Time

    Intraoperative

Study Arms (2)

Oyxgen

EXPERIMENTAL

Nasal Insufflation with 15 L/min O2 and a nasopharyngeal airway

Other: Oxygen

Air

ACTIVE COMPARATOR

Nasal Insufflation with 15 L/min air and a nasopharyngeal airway

Other: Air

Interventions

OxygenOTHER

15 L/min O2

Oyxgen
AirOTHER

15 L/min air

Air

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Parkland Health & Hospital System

Dallas, Texas, 75235, United States

Location

Related Publications (16)

  • Jense HG, Dubin SA, Silverstein PI, O'Leary-Escolas U. Effect of obesity on safe duration of apnea in anesthetized humans. Anesth Analg. 1991 Jan;72(1):89-93. doi: 10.1213/00000539-199101000-00016.

    PMID: 1984382BACKGROUND

  • Huang KC, Kormas N, Steinbeck K, Loughnan G, Caterson ID. Resting metabolic rate in severely obese diabetic and nondiabetic subjects. Obes Res. 2004 May;12(5):840-5. doi: 10.1038/oby.2004.101.

    PMID: 15166305BACKGROUND

  • McCahon RA, Hardman JG. Fighting for breath: apnoea vs the anaesthetist. Anaesthesia. 2007 Feb;62(2):105-8. doi: 10.1111/j.1365-2044.2007.04932.x. No abstract available.

    PMID: 17223799BACKGROUND

  • Baraka AS, Taha SK, Siddik-Sayyid SM, Kanazi GE, El-Khatib MF, Dagher CM, Chehade JM, Abdallah FW, Hajj RE. Supplementation of pre-oxygenation in morbidly obese patients using nasopharyngeal oxygen insufflation. Anaesthesia. 2007 Aug;62(8):769-73. doi: 10.1111/j.1365-2044.2007.05104.x.

    PMID: 17635423BACKGROUND

  • Baraka AS, Taha SK, Aouad MT, El-Khatib MF, Kawkabani NI. Preoxygenation: comparison of maximal breathing and tidal volume breathing techniques. Anesthesiology. 1999 Sep;91(3):612-6. doi: 10.1097/00000542-199909000-00009.

    PMID: 10485768BACKGROUND

  • Ramachandran SK, Cosnowski A, Shanks A, Turner CR. Apneic oxygenation during prolonged laryngoscopy in obese patients: a randomized, controlled trial of nasal oxygen administration. J Clin Anesth. 2010 May;22(3):164-8. doi: 10.1016/j.jclinane.2009.05.006.

    PMID: 20400000BACKGROUND

  • Lopez PP, Stefan B, Schulman CI, Byers PM. Prevalence of sleep apnea in morbidly obese patients who presented for weight loss surgery evaluation: more evidence for routine screening for obstructive sleep apnea before weight loss surgery. Am Surg. 2008 Sep;74(9):834-8.

    PMID: 18807673BACKGROUND

  • Heier T, Feiner JR, Lin J, Brown R, Caldwell JE. Hemoglobin desaturation after succinylcholine-induced apnea: a study of the recovery of spontaneous ventilation in healthy volunteers. Anesthesiology. 2001 May;94(5):754-9. doi: 10.1097/00000542-200105000-00011.

    PMID: 11388524BACKGROUND

  • Campbell IT, Beatty PC. Monitoring preoxygenation. Br J Anaesth. 1994 Jan;72(1):3-4. doi: 10.1093/bja/72.1.3. No abstract available.

    PMID: 8110546BACKGROUND

  • FRUMIN MJ, EPSTEIN RM, COHEN G. Apneic oxygenation in man. Anesthesiology. 1959 Nov-Dec;20:789-98. doi: 10.1097/00000542-195911000-00007. No abstract available.

    PMID: 13825447BACKGROUND

  • Dixon BJ, Dixon JB, Carden JR, Burn AJ, Schachter LM, Playfair JM, Laurie CP, O'Brien PE. Preoxygenation is more effective in the 25 degrees head-up position than in the supine position in severely obese patients: a randomized controlled study. Anesthesiology. 2005 Jun;102(6):1110-5; discussion 5A. doi: 10.1097/00000542-200506000-00009.

    PMID: 15915022BACKGROUND

  • Damia G, Mascheroni D, Croci M, Tarenzi L. Perioperative changes in functional residual capacity in morbidly obese patients. Br J Anaesth. 1988 Apr;60(5):574-8. doi: 10.1093/bja/60.5.574.

    PMID: 3377932BACKGROUND

  • Don HF, Wahba M, Cuadrado L, Kelkar K. The effects of anesthesia and 100 per cent oxygen on the functional residual capacity of the lungs. Anesthesiology. 1970 Jun;32(6):521-9. doi: 10.1097/00000542-197006000-00012. No abstract available.

    PMID: 5426264BACKGROUND

  • Taha SK, Siddik-Sayyid SM, El-Khatib MF, Dagher CM, Hakki MA, Baraka AS. Nasopharyngeal oxygen insufflation following pre-oxygenation using the four deep breath technique. Anaesthesia. 2006 May;61(5):427-30. doi: 10.1111/j.1365-2044.2006.04610.x.

    PMID: 16674614BACKGROUND

  • Dyett JF, Moser MS, Tobin AE. Prospective observational study of emergency airway management in the critical care environment of a tertiary hospital in Melbourne. Anaesth Intensive Care. 2015 Sep;43(5):577-86. doi: 10.1177/0310057X1504300505.

    PMID: 26310407BACKGROUND

  • Sakles JC, Mosier JM, Patanwala AE, Dicken JM. Apneic oxygenation is associated with a reduction in the incidence of hypoxemia during the RSI of patients with intracranial hemorrhage in the emergency department. Intern Emerg Med. 2016 Oct;11(7):983-92. doi: 10.1007/s11739-016-1396-8. Epub 2016 Feb 4.

    PMID: 26846234BACKGROUND

MeSH Terms

Conditions

Apnea

Interventions

OxygenAir

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ChalcogensElementsInorganic ChemicalsGasesAtmosphereEnvironmentEcological and Environmental PhenomenaBiological PhenomenaMeteorological ConceptsEnvironment and Public Health

Study Officials

  • Tiffany Moon, MD

    University of Texas Southwestern Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 12, 2018

First Posted

September 14, 2018

Study Start

July 12, 2017

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

March 11, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)