Nasal Mask Ventilation During the Induction of General Anesthesia - Full Text View

Purpose

Recently, the investigators demonstrated that nasal route ventilation is superior to the nasal-oral combined ventilation in the absence of jaw thrust and chin up maneuvers. The investigators hypothesize nasal mask ventilation may reduce the incidence of difficult mask ventilation during the induction of general anesthesia by: 1) producing a better seal than full face mask, and 2)establishing a greater airway patency and more effectively ventilate than full face mask ventilation. The investigators intend to test this hypothesis on adult patients during the induction of general anesthesia in the absence of muscle relaxation.

Condition	Intervention
Mechanical Ventilation Complication Upper Airway Obstruction	Procedure: nasal mask Procedure: full face mask

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Supportive Care
Official Title:	Determination of the Efficacy of Nasal Mask Ventilation During the Induction of General Anesthesia

Resource links provided by NLM:

MedlinePlus related topics: Choking

U.S. FDA Resources

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:

Tidal volume [ Time Frame: in 30 minutes after the induction of general anesthesia ] [ Designated as safety issue: No ]
Tidal volume generated by the positive pressure ventilation during the induction of general anesthesia

Secondary Outcome Measures:

Carbon dioxide removal [ Time Frame: in 30 minutes after the induction of general anesthesia ] [ Designated as safety issue: No ]
carbon dioxide removed per minute during the induction of general anesthesia will be calculated
success rate of positive pressure ventilation with different masks [ Time Frame: in 30 minute after the induction of general anesthesia ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	52
Study Start Date:	June 2012
Estimated Study Completion Date:	August 2013
Estimated Primary Completion Date:	June 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: nasal mask when the patient is apneic after the injection of anesthetics in the operating room, a nasal mask will be applied with positive pressure ventilation for 1 min. Then the nasal mask will be replaced with a full face mask for 1 min. Subsequently, the face mask will be replaced with the nasal mask.	Procedure: nasal mask Using the nasal mask instead of the full face mask during the induction of general anesthesia Procedure: full face mask using a standard full face mask during the induction of general anesthesia.
Active Comparator: full face mask when the patient is apneic after the injection of anesthetics in the operating room, a full face mask will be applied with positive pressure ventilation for 1 min. Then the full face mask will be replaced with a nasal mask for 1 min. Subsequently, the nasal mask will be replaced with the full face mask.	Procedure: nasal mask Using the nasal mask instead of the full face mask during the induction of general anesthesia Procedure: full face mask using a standard full face mask during the induction of general anesthesia.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

18-65 years of age
ASA physical status classification I-II
general anesthesia
elective surgery
who are able to breathe through both their nose and mouth while awake

Exclusion Criteria:

Patients with major cardiovascular disease, respiratory disease, cerebral vascular disease or American Society of Anesthesiologists physical status class III 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.
Unable to open mouth (<2.5 cm) or unable to breathe through their mouth or nose.
Any person with an anticipated difficult airway. This will include subjects that require or may require either a fiberoptic intubation or intubation while awake.
Gastric-esophageal reflex or a full stomach.
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 - Nothing By Mouth) guidelines.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01651286

Contacts

Contact: Hovig Chitilian, MD		HCHITILIAN@PARTNERS.ORG
Contact: Yandong Jiang, MD, PhD		YJIANG@PARTNERS.ORG

Locations

United States, Massachusetts
Massachusetts General Hospital	Recruiting
Boston, Massachusetts, United States, 02114
Contact: Yandong Jiang, MD, PhD YJIANG@PARTNERS.ORG
Principal Investigator: Yandong Jiang, MD, PhD

Sponsors and Collaborators

Massachusetts General Hospital

Investigators

Principal Investigator:	Hovig V Chitilian, MD	Massachusetts General Hospital
Principal Investigator:	Yandong Jiang, MD, PhD	Massachusetts General Hospital

More Information

No publications provided

Responsible Party:	Yandong Jiang, Assistant Professor, Massachusetts General Hospital
ClinicalTrials.gov Identifier:	NCT01651286 History of Changes
Other Study ID Numbers:	2011P001283
Study First Received:	June 6, 2012
Last Updated:	July 24, 2012
Health Authority:	United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:

General anesthesia
Positive-pressure ventilation
Masks

Additional relevant MeSH terms:

Airway Obstruction
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases
Anesthetics

Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 22, 2013