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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by Massachusetts General Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Yandong Jiang, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01627925
First received: June 22, 2012
Last updated: July 3, 2012
Last verified: July 2012

June 22, 2012
July 3, 2012
June 2012
April 2013   (final data collection date for primary outcome measure)
Expired tidal volume [ Time Frame: About two minute during induction of general anesthesia ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01627925 on ClinicalTrials.gov Archive Site
Volume of CO2 [ Time Frame: About two minute during induction of general anesthesia ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Safety Study of Positive Airway Pressure Via a Nasal Mask in Obese Patients
Safety Study of Positive Airway Pressure Via a Nasal Mask on Upper Airway Patency During Induction of Anesthesia in Obese Patients

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.

Upper airway obstruction (UAO) is an unpredictable and frequently occurring complication during induction of general anesthesia. Since obese patients ( BMI>30 km/ m2) are more vulnerable to develop airway obstruction either during sleep 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". Unfortunately, even with modern technologic advances, 16% of death and permanent brain damage related to anesthesia have been attributed to failure of difficult airway management 3. 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. Indeed, it can be a fatal complication of general anesthesia. Therefore, measures used to reduce the incidence of difficult airways during anesthesia remain to be improved.

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. Accordingly, 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. More and more evidence indicates that 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, if they can tolerate it. Under anesthesia, tolerance should not be an issue as the patient is anesthetized. 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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Upper Airway Obstruction
Device: nasal mask and continuous positive airway pressure
nasal mask use instead of face mask application of continuous positive airway pressure during induction of general anesthesia
Other Name: nasal mask (Contour delux, Respironics)
  • Experimental: Face mask and nasal mask without PEEP
    Face mask ventilation and nasal mask ventilation without PEEP
    Intervention: Device: nasal mask and continuous positive airway pressure
  • Experimental: Nasal mask and face mask with PEEP
    Nasal mask ventilation and face mask ventilation with PEEP
    Intervention: Device: nasal mask and continuous positive airway pressure
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
32
June 2013
April 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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.

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.

Both
18 Years to 65 Years
No
Contact: Yandong Jiang, MD, PhD 617-724-2250 YJIANG@PARTNERS.ORG
Contact: Jun Oto, MD, PhD 617-724-4496 JOTO@PARTNERS.ORG
United States
 
NCT01627925
2012-P-000054
Yes
Yandong Jiang, Massachusetts General Hospital
Massachusetts General Hospital
Not Provided
Principal Investigator: Yandong Jiang, MD, PhD Massachusetts General Hospital
Massachusetts General Hospital
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP