Safety Study of Continuous Positive Airway Pressure Via a Nasal Mask

NCT ID: NCT01524614

Last Updated: 2017-01-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2012-05-31

Brief Summary

Upper airway obstruction (UAO) is common complication during induction of general anesthesia. The mechanism of UAO during anesthesia has not been well understood. Posterior displacement of soft palate are believed to be the primary contributing factors. The mechanism of UAO during anesthesia share many similarities with obstructive sleep apnea (OSA). Since nasal continuous positive airway pressure (nCPAP) can maintain the airway patent in patients with OSA, the investigators hypothesize that nCPAP during induction of anesthesia will reduce the incidence and severity of UAO.

Conditions

Upper Airway Obstruction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Nasal mask with no PEEP

Nasal mask with PEEP 0, then add PEEP 5, and 10

Group Type: EXPERIMENTAL

nasal mask

Intervention Type: PROCEDURE

nasal mask use instead of face mask

Nasal mask with PEEP

Nasal mask with PEEP 5, then add PEEP 10

Group Type: EXPERIMENTAL

nasal mask

Intervention Type: PROCEDURE

nasal mask use instead of face mask

Face mask with no PEEP

Face mask with PEEP 0 then add PEEP 5, 10

Group Type: EXPERIMENTAL

nasal mask

Intervention Type: PROCEDURE

nasal mask use instead of face mask

Face mask with PEEP

Face mask with PEEP 5, then add PEEP 10

Group Type: EXPERIMENTAL

nasal mask

Intervention Type: PROCEDURE

nasal mask use instead of face mask

Interventions

nasal mask

nasal mask use instead of face mask

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

Patients,between 18-65 years of age meeting ASA physical status classification I-II requiring general anesthesia for elective surgery who are 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 III 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. Unable to open mouth (< 2.5 cm) or unable to breathe through their mouth or nose.

4. Subjects with a beard, an abnormal facial structure or other factors precluding obtaining a viable face mask fit without air leak. Also, subjects having claustrophobia that can not tolerate the mask.

5. Any person with an anticipated difficult airway. This will include subjects who require or may require either a fiberoptic intubation or intubation while awake and subjects with known OSA or body mass index (BMI) greater than 35 km/m2.

6. Gastric-esophageal reflex or a full stomach.

7. The subject has remained in bed for more than 24 hours.

8. 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.

9. 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.

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Yandong Jiang

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yandong Jiang, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Anesthesia and Critical Care, Mass General Hospital

Boston, Massachusetts, United States

Countries

United States

References

Oto J, Li Q, Kimball WR, Wang J, Sabouri AS, Harrell PG, Kacmarek RM, Jiang Y. Continuous positive airway pressure and ventilation are more effective with a nasal mask than a full face mask in unconscious subjects: a randomized controlled trial. Crit Care. 2013 Dec 23;17(6):R300. doi: 10.1186/cc13169.

Reference Type: DERIVED

PMID: 24365207 (View on PubMed)

Other Identifiers

2010p002823

Identifier Type: -

Identifier Source: org_study_id