Nasal Continuous Positive Airway Pressure and Airway Patency in Obese Patient

Comparison of Upper Airway Patency Using Continuous Positive Airway Pressure Ventilation Via a Nasal Mask With a Face Mask During Induction of Anesthesia on Obese Patients

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.

Study Overview

• Status: Completed
• Conditions: Obese
• Intervention / Treatment: Device: nasal mask CPAP

Detailed Description

Upper airway obstruction (UAO) is an unpredictable and frequently occurring complication during induction of general anesthesia. Since obese patients are more vulnerable to develop airway obstruction either during sleep1 or under anesthesia, and the segment of obese individuals in the entire population keep growing, difficult airway management under anesthesia becomes even more challenging than ever. The most serious event related to difficult airway management under anesthesia is "cannot intubate, cannot ventilate".

The mechanism of UAO during anesthesia has not been well understood. Obese patients are a high-risk group for perioperative airway catastrophe and prone to develop progressively narrower pharyngeal airways due to an increase of soft tissue volume surrounding the pharyngeal airway. The mechanism of 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. Therefore, 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.

• Study Type: Observational
• Enrollment (Actual): 32

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

adult obese patient undergoing general anesthesia

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Patients with major cardiovascular disease, respiratory disease, cerebral vascular disease or American Society of Anesthesiologists physical status class IV or greater.
2. 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.
3. Having claustrophobia and not able to tolerate the mask.
4. 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.
5. Gastric-esophageal reflex disease that is refractory to treatment or a full stomach.
6. The subject has been in bed for more than 24 hours.
7. 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.
8. 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.

9. Emergency cases and subjects who have not adhered to the ASA NPO (Nil Per Os) guidelines.

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Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
FmCPAP; CPAP ventilation administered via face mask	Device: nasal mask CPAP; CPAP and ventilation administered via nasal mask; Other Names: nCPAP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
expired tidal volume/Area under the Curve of the pressure trace	The area under the airway pressure curve (AUC) defined as the area from the baseline pressure to the peak pressure during inspiration was calculated for evaluating pressure applied during inspiration. The AUC is a reflection of the change in mean airway pressure.	3 minutes

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: March 13, 2013
• First Submitted That Met QC Criteria: January 15, 2017
• First Posted (Estimate): January 19, 2017

Study Record Updates

• Last Update Posted (Actual): March 21, 2017
• Last Update Submitted That Met QC Criteria: March 17, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: nasal CPAP; Obese patient
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: 2013-P-000095/1