Comparison of the Efficiency of Mouth-to-nose Breathing With Mouth-to-mouth Breathing - Full Text View

Sponsor:	Massachusetts General Hospital
Information provided by:	Massachusetts General Hospital
ClinicalTrials.gov Identifier:	NCT00785447

Purpose

The purpose of this study is to find out the best way of providing artificial breathing during cardiopulmonary resuscitation (CPR). Current standard CPR involves giving mouth-to-mouth breathing to people requiring CPR. The rescuer pinches the person's nostrils closed and breathes into the mouth of the unconscious person with his or her own mouth.

Some CPR studies have shown that it might be easier and more effective to breathe air into a person's nose instead of the mouth. People receiving CPR often have blocked airways, so breathing into the mouth does not always work.

We think mouth-to-nose breathing may be more efficient and easier to do. In this case, the rescuer closes the person's mouth by pushing the jaw up and holding it still. Then the rescuer breathes into the unconscious person's nose by covering the nose entirely with his or her mouth. We are doing this study to try to find out which way works better.

We will perform both ways of breathing on people who are unconscious (asleep) before planned (non-emergency) surgery and compare their effectiveness.

Condition	Intervention
Cardiopulmonary Resuscitation Respiratory Physiology	Other: Mouth-to-mouth or mouth-to-nose breathing

Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Comparison of the Efficiency of Mouth-to-nose Breathing With Mouth-to-mouth Breathing in Non-paralyzed Adult Patients Under General Anesthesia

Resource links provided by NLM:

MedlinePlus related topics: CPR

U.S. FDA Resources

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:

Comparing CO2 elimination with mouth-to-nose versus mouth-to-mouth breathing in non-paralyzed adult patients under general anesthesia. [ Time Frame: 1.5 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	25
Study Start Date:	March 2008
Estimated Study Completion Date:	January 2012
Estimated Primary Completion Date:	September 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1 Twenty-five healthy subjects between 18 to 59 years of age meeting ASA I-II criteria, undergoing elective surgery, requiring general anesthesia and being able to breathe through both their nose and mouth.	Other: Mouth-to-mouth or mouth-to-nose breathing Patients undergoing elective surgery under general anesthesia will be given mouth-to-mouth and mouth-to-nose breaths. The respiration process will be measured and recorded by the help of elastic bands put around the chest and abdomen. The efficiency of the breathing methods will be evaluated.

Eligibility

Ages Eligible for Study:	18 Years to 59 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Healthy subjects between 18 to 59 years of age
meeting ASA I-II criteria
Undergoing elective surgery and requiring general anesthesia
Being able to breathe through both the nose and the mouth while awake

Exclusion Criteria:

Patients with known infectious diseases, bacteria infections such as Neisseria meningitidis, upper respiratory tract infection (URI), bacterial pneumonia, etc. and patients with known HIV, HBV, HCV, or TB infection. Patients with broken oral mucosa or obvious sores.
Patients with immunosuppression from radiotherapy, chemotherapy, etc.
Patients with cardiovascular disease, respiratory disease, cerebral vascular disease and ASA class III or greater risk for anesthesia as defined by the American Society of Anesthesiologists.
Abnormal vital signs on the day of admission for surgery (HR, BP, room air oxygen saturation, EKG) that are not correctable with his or her routine medication or commonly used pre-operative medication.
Ischemic heart disease with chest pain or arrhythmias, patients with a pacemaker or AICD device and patients with heart failure.
Respiratory diseases, including subjects with COPD, asthma, pulmonary hypertension, restrictive lung disease, pleural effusion, tracheal stenosis and tracheal malacia, respiratory tract infection within the preceding week and those with previous pneumonectomy, lobectomy, tracheostomy, laryngectomy, tongue resection, and pharyngeal laryngeal plasity.
Unable to open mouth (<2.5 cm) or unable to breathe through mouth or nose.
Anticipated difficult airway: Mallampati score of III or greater, decreased neck movement, decreased mandibular movement, history of therapeutic radiation to the larynx or neck, prominent incisors. Subjects require or may require fiberoptic intubation
Important nasal septum deviation or other conditions impairing nasal breathing. The patient's nasal patency will be confirmed by inspiring with the mouth shut and open.
Gastric-esophageal reflex or a full stomach.
Obese with BMI greater than 35.
Neurological symptoms associated with neck extension, neurological deficit from previous stroke or spinal cord injury, recent stroke or 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 done routinely prior to a 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 guidelines.
Prisoners.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00785447

Contacts

Contact: Yandong Jiang, MD, PhD	617-7242366	yjiang@partners.org
Contact: Robert Kacmarek, PhD, RRT	617-7244480	rkacmarek@partners.org

Locations

United States, Massachusetts
Massachusetts General Hospital	Recruiting
Boston, Massachusetts, United States, 02114
Contact: Robert Kacmarek, PhD,RRT 617-724-4480 rkacmarek@partners.org
Contact: Yandong Jiang, MD 617-7242366 yjiang@partners.org
Principal Investigator: Yandong Jiang, MD, PhD

Sponsors and Collaborators

Massachusetts General Hospital

Investigators

Principal Investigator:

Yandong Jiang, MD, PhD

Massachusetts General Hospital

More Information

No publications provided

Responsible Party:	Robert Kacmarek, PhD, RRT, Massachusetts General Hospital
ClinicalTrials.gov Identifier:	NCT00785447 History of Changes
Other Study ID Numbers:	2007-P-001680
Study First Received:	October 30, 2008
Last Updated:	July 6, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:

Cardiopulmonary Resuscitation
Respiratory Physiology
Mouth to mouth ventilation
Mouth to nose ventilation

Additional relevant MeSH terms:

Respiratory Aspiration
Mouth Breathing
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms

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

ClinicalTrials.gov processed this record on February 09, 2012