Safety Study of Positive Airway Pressure Via a Nasal Mask in Obese Patients

NCT01627925 | Withdrawn Phase 3 DMC

• 1 other identifier: 2012-P-000054
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Upper airway obstruction (UAO) is a frequently occurring complication during induction of general anesthesia. The American Society of Anesthesiologist (ASA) closed claim analysis of anesthesia complications indicate that a difficult airway is one of the most challenging scenarios continuously facing anesthesia providers. The mechanism of UAO during anesthesia has not been well understood. Posterior displacement of soft palate, tongue and epiglottis are believed to be the primary contributing factors. Obesity is well known to be an essential characteristic which reflects propensity to UAO. 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.

Conditions

Upper Airway Obstruction

Keywords

nasal positive airway pressure; upper airway obstruction; mask ventilation

Outcome Measures

Primary Outcomes (1)

• Expired tidal volume

  About two minute during induction of general anesthesia

Secondary Outcomes (1)

• Volume of CO2

  About two minute during induction of general anesthesia

Study Arms (2)

Face mask and nasal mask without PEEP

EXPERIMENTAL

Face mask ventilation and nasal mask ventilation without PEEP

Device: nasal mask and continuous positive airway pressure

Nasal mask and face mask with PEEP

EXPERIMENTAL

Nasal mask ventilation and face mask ventilation with PEEP

Device: nasal mask and continuous positive airway pressure

Interventions

nasal mask and continuous positive airway pressure DEVICE

nasal mask use instead of face mask application of continuous positive airway pressure during induction of general anesthesia

Also known as: nasal mask (Contour delux, Respironics)

Face mask and nasal mask without PEEP; Nasal mask and face mask with PEEP

Eligibility Criteria

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

You may qualify if:

• Thirty-two subjects with BMI limited in the range of 30 km/ m2 to 50 km/m2 and age of 18-65 years will be enrolled. Subjects must also meet ASA physical status classification I-III, require general anesthesia for elective surgery and be able to breathe through both their nose and mouth while awake.

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. 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.
• \. Gastric-esophageal reflex disease that is refractory to treatment or a full stomach.
• \. 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.
• \. 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

Airway Obstruction

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Respiratory Insufficiency; Respiration Disorders; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Yandong Jiang, MD, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associated professor

Study Record Dates

• First Submitted: June 22, 2012
• First Posted: June 26, 2012
• Study Start: June 1, 2012
• Primary Completion: April 1, 2013
• Study Completion: June 1, 2013
• Last Updated: January 18, 2017

Record last verified: 2017-01

Locations

US (1)