Back to results

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

Primary Purpose

Apneic; Oxygenation

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Oxygen

Air

About this trial

This is an interventional treatment trial for Apneic; Oxygenation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

Parkland Health & Hospital System

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Oyxgen

Air

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Resaturation Time

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

Full Information

NCT ID

NCT03671837

First Posted

September 12, 2018

Last Updated

March 10, 2020

Sponsor

University of Texas Southwestern Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT03671837

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2020

Overall Recruitment Status

Completed

Study Start Date

July 12, 2017 (Actual)

Primary Completion Date

December 31, 2019 (Actual)

Study Completion Date

December 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Texas Southwestern Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Apneic; Oxygenation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

135 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Oyxgen

Arm Type

Experimental

Arm Description

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

Arm Title

Air

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Other

Intervention Name(s)

Oxygen

Intervention Description

15 L/min O2

Intervention Type

Other

Intervention Name(s)

Air

Intervention Description

15 L/min air

Primary Outcome Measure Information:

Title

Apneic Time

Description

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.

Time Frame

Intraoperative

Secondary Outcome Measure Information:

Title

Resaturation Time

Description

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

Time Frame

Intraoperative

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Tiffany Moon, MD

Organizational Affiliation

University of Texas Southwestern Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Parkland Health & Hospital System

City

Dallas

State/Province

Texas

ZIP/Postal Code

75235

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

1984382

Citation

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.

Results Reference

background

PubMed Identifier

15166305

Citation

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.

Results Reference

background

PubMed Identifier

17223799

Citation

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.

Results Reference

background

PubMed Identifier

17635423

Citation

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.

Results Reference

background

PubMed Identifier

10485768

Citation

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.

Results Reference

background

PubMed Identifier

20400000

Citation

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.

Results Reference

background

PubMed Identifier

18807673

Citation

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.

Results Reference

background

PubMed Identifier

11388524

Citation

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.

Results Reference

background

PubMed Identifier

8110546

Citation

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. Erratum In: Br J Anaesth 1994 May;72(5):612.

Results Reference

background

PubMed Identifier

13825447

Citation

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.

Results Reference

background

PubMed Identifier

15915022

Citation

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.

Results Reference

background

PubMed Identifier

3377932

Citation

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.

Results Reference

background

PubMed Identifier

5426264

Citation

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.

Results Reference

background

PubMed Identifier

16674614

Citation

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.

Results Reference

background

PubMed Identifier

26310407

Citation

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.

Results Reference

background

PubMed Identifier

26846234

Citation

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.

Results Reference

background

Learn more about this trial

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

We'll reach out to this number within 24 hrs