Nasal Continuous Positive Airway Pressure and Airway Patency in Obese Patient

NCT03024723 | Completed DMC

• 1 other identifier: 2013-P-000095/1
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

The mechanism of Upper airway obstruction (UAO) during anesthesia shares many similarities with the upper airway obstruction observed during obstructive sleep apnea (OSA). Nasal continuous positive airway pressure (nCPAP) via nasal mask (NM) can maintain the airway patent with near 100% success in patients with OSA. Obesity is a major risk factors for obstructive sleep apnea and obese patients have a higher prevalence of UAO during anesthesia. The investigators hypotheses that nCPAP should eliminate airway obstruction in obese patients under anesthesia. The investigators propose to test this hypothesis and determine the efficacy of nCPAP on maintaining airway patency in obese patients who require general anesthesia compared with CPAP administering face mask.

Conditions

Obese

Keywords

Obese patient; nasal CPAP

Outcome Measures

Primary Outcomes (1)

• expired tidal volume

  This group of the subjects will start with nasal mask or face mask CPAP ventilation. The anesthesia care team does whatever they routinely do, including adjusting the patient's position (as to reverse Trendelenburg position), pre-oxygenation, pre-medication, as usual with intravenous anesthetics and analgesics. When the patient is apneic, CPAP ventilation will be initiated with pressure support mode at PIP 25 cmH2O, ventilation rate 10 BPM, PEEP 10 cmH2O and slope 1 second for 1 min. If ventilation is effective in one of the first three breaths, the ventilation will continue for 1 min. If effective ventilation cannot be produced in any of the first three breaths, the study will be terminated and routine care will be provided.

  3 minutes

Secondary Outcomes (1)

• expired tidal volume/Area under the Curve of the pressure trace

  3 minutes

Study Arms (1)

FmCPAP

CPAP ventilation administered via face mask

Device: nasal mask CPAP

Interventions

nasal mask CPAP DEVICE

CPAP and ventilation administered via nasal mask

Also known as: nCPAP

FmCPAP

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

adult obese patient undergoing general anesthesia

You may qualify if:

• Body Mass Index:30 to 50 kg/ m2, Age: 18-65 years old ASA physical status classification: I-III Requiring general anesthesia for elective surgery

You may not qualify if:

• Patients with major cardiovascular disease, respiratory disease, cerebral vascular disease or American Society of Anesthesiologists physical status class IV or greater.
• Abnormal vital signs on the day of admission for surgery \[heart rate (HR, \>100 bpm or \<40 bpm), blood pressure (BP, \>180/100 mmHg or \<90/60 mmHg), room air transcutaneous oxyhemoglobin saturation (SPO2) \<96%\] that are not correctable with his or her routine medication or commonly used pre-operative medication.
• Having claustrophobia and not able to tolerate the mask.
• Any person with an anticipated difficult airway or those with a history of difficult airway. This will include subjects who require or may require either a fiberoptic intubation or intubation while awake.
• Gastric-esophageal reflex disease that is refractory to treatment or a full stomach.
• The subject has been in bed for more than 24 hours.
• Neurological symptoms associated with neck extension, a neurological deficit from a previous stroke or spinal cord injury, a recent stroke or transient ischemic attack (TIA) within 2 weeks.
• Pregnant women and women less than one month post-partum. Ruling out pregnancy will be conducted by careful history and physical examination as performed routinely prior to surgery. If the history is believed to be unreliable, the patient will be excluded unless a pregnancy test is performed and the result of the test is negative.
• Emergency cases and subjects who have not adhered to the ASA NPO (Nil Per Os) guidelines.

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Yandong Jiang, MD, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: March 13, 2013
• First Posted: January 19, 2017
• Study Start: April 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: March 21, 2017

Record last verified: 2017-03

Locations

US (1)