Effect of Body Positioning on Upper Airway Patency During Induction of Anesthesia in Obese Patients
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|ClinicalTrials.gov Identifier: NCT01811069|
Recruitment Status : Completed
First Posted : March 14, 2013
Last Update Posted : January 18, 2017
|Condition or disease||Intervention/treatment|
|Obese||Procedure: Head up|
This is a prospective, observational study. Fifteen subjects with BMI limited in the range of 30 kg/m2 to 50 kg/m2, between 18-65 years of age meeting ASA physical status classification I-III requiring general anesthesia for elective surgery will be recruited from the main operating room of the Massachusetts General Hospital. We will start the recruiting process at least 12 hours ahead of the surgery at a pre-admission test area.
The PI/Co-I who approaches a potential subject who has expressed interest will not be the anesthesiologist providing anesthesia care for the subjects. In addition the PI/Co-I approaching the patient will reinforce that she or he does not have to participate and that the decision not to participate will not affect their care at anytime.
The Principal Investigator or Co-Investigator will participate in the informed consent process in operative holding area. Subjects to be recruited will be given a thorough review of the informed consent, as well as the study purpose and procedures, and its risks, discomforts, and potential benefits. When the subject is comfortable with and knowledgeable about the protocol, he or she will sign the consent form in the presence of the investigator. Investigator will also sign the informed consent form. All subjects will be given ample time to read the consent form and consider participating in the trial. Any complaint or problems related to our recruitment plan will report in real time to the IRB.
|Study Type :||Observational [Patient Registry]|
|Actual Enrollment :||13 participants|
|Observational Model:||Case Control|
|Target Follow-Up Duration:||1 Day|
|Official Title:||Effect of Body Positioning on Upper Airway Patency During Induction of Anesthesia in Obese Patients|
|Study Start Date :||April 2013|
|Actual Primary Completion Date :||January 2014|
|Actual Study Completion Date :||January 2014|
- Procedure: Head up
30˚ reverse trendelenburg body position
- expired tidal volume [ Time Frame: 5 minutes ]The ventilation will continue for 1 min in flat position and then, operating table will be changed to 30˚ reverse trendelenburg position and the ventilation will continue for 1 min. Then, operating table will leveled and the ventilation will continue for 1 min.
- Vte/Area under the Curve (AUC) of the pressure trace during mask ventilation [ Time Frame: 5 minutes ]The area under the airway pressure curve (AUC) defined as the area from the baseline pressure to the peak pressure during inspiration was calculated for evaluating pressure applied during inspiration.The AUC is a reflection of the change in mean airway pressure.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01811069
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Yandong Jiang, MD, PhD||Massachusetts General Hospital|