Cardiopulmonary ResuscitationNCT00785447
Comparison of the Efficiency of Mouth-to-nose Breathing With Mouth-to-mouth Breathing
A study testing Mouth-to-mouth or mouth-to-nose breathing in people with Cardiopulmonary Resuscitation and Respiratory Physiology, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 59 years
- Conditions the study is for
- Cardiopulmonary Resuscitation, Respiratory Physiology
- What is being tested?
- Mouth-to-mouth or mouth-to-nose breathing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2008to Jan 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Comparison of the Efficiency of Mouth-to-nose Breathing With Mouth-to-mouth Breathing in Non-paralyzed Adult Patients Under General Anesthesia
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.
Read more
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.
- Being tested
- Mouth-to-mouth or mouth-to-nose breathing
- Keywords
- Cardiopulmonary Resuscitation, Respiratory Physiology, Mouth to mouth ventilation, Mouth to nose ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mouth-to-mouth or mouth-to-nose breathingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | 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. Receives: Other: Mouth-to-mouth or mouth-to-nose breathing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparing CO2 elimination with mouth-to-nose versus mouth-to-mouth breathing in non-paralyzed adult patients under general anesthesia.
Measured: 1.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2008 (estimated)
- Study startMar 2008
- Primary completionJan 2010
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiopulmonary ResuscitationStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert M. Kacmarek, Massachusetts General Hospital
- Investigators
- Yandong Jiang, MD, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00785447
- Sponsor's protocol ID
- 2007-P-001680
- Status last verified
- Apr 2012
- First submitted
- 30 Oct 2008
- Last updated
- 25 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficiency of Mouth-to-nose Breathing With Mouth-to-mouth Breathing in Non-paralyzed Adult Patients Under General Anesthesia
- ClinicalTrials.gov ID
- NCT00785447
- Acronym / sponsor ID
- 2007-P-001680
- Keywords
- Cardiopulmonary Resuscitation, Respiratory Physiology, Mouth to mouth ventilation, Mouth to nose ventilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 5 Nov 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Other: Mouth-to-mouth or mouth-to-nose breathingTwenty 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. |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mouth-to-mouth or mouth-to-nose breathingPatients 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. | Other | 1 |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yandong Jiang, MD, PhD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mouth-to-mouth or mouth-to-nose breathing in people with Cardiopulmonary Resuscitation and Respiratory Physiology, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2012.