Comparison of the Efficiency of Mouth-to-nose Breathing With Mouth-to-mouth Breathing
This study has been completed.
Sponsor:
Massachusetts General Hospital
Information provided by (Responsible Party):
Robert M. Kacmarek, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00785447
First received: October 30, 2008
Last updated: April 24, 2012
Last verified: April 2012
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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:
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 ]
| Enrollment: | 20 |
| Study Start Date: | March 2008 |
| Study Completion Date: | January 2010 |
| Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1
Twenty 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
Locations
| United States, Massachusetts | |
| Massachusetts General Hospital | |
| Boston, Massachusetts, United States, 02114 | |
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
| Principal Investigator: | Yandong Jiang, MD, PhD | Massachusetts General Hospital |
More Information
No publications provided
| Responsible Party: | Robert M. Kacmarek, Professor of Anesthesia, Director of Respiratory Care Services, 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: | April 24, 2012 |
| 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 May 23, 2013