Comparison of the Efficiency of Mouth-to-nose Breathing With Mouth-to-mouth Breathing
| Tracking Information | |||||
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| First Received Date ICMJE | October 30, 2008 | ||||
| Last Updated Date | April 24, 2012 | ||||
| Start Date ICMJE | March 2008 | ||||
| Primary Completion Date | January 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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 ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00785447 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Comparison of the Efficiency of Mouth-to-nose Breathing With Mouth-to-mouth Breathing | ||||
| Official Title ICMJE | Comparison of the Efficiency of Mouth-to-nose Breathing With Mouth-to-mouth Breathing in Non-paralyzed Adult Patients Under General Anesthesia | ||||
| Brief 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. 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE | 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. |
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| Study Arm (s) | 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.
Intervention: Other: Mouth-to-mouth or mouth-to-nose breathing |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 20 | ||||
| Completion Date | January 2010 | ||||
| Primary Completion Date | January 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 59 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00785447 | ||||
| Other Study ID Numbers ICMJE | 2007-P-001680 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Robert M. Kacmarek, Massachusetts General Hospital | ||||
| Study Sponsor ICMJE | Massachusetts General Hospital | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Massachusetts General Hospital | ||||
| Verification Date | April 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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