Ignite Creation Date:
2025-12-24 @ 11:08 PM
Ignite Modification Date:
2026-03-03 @ 5:03 PM
Study NCT ID:
NCT01811069
Status:
COMPLETED
Last Update Posted:
2017-01-18
First Post:
2013-03-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Body Positioning on Upper Airway Patency During Induction of Anesthesia in Obese Patients
Sponsor:
Massachusetts General Hospital
Organization:
Study Overview
Official Title:
Effect of Body Positioning on Upper Airway Patency During Induction of Anesthesia in Obese Patients
Status:
COMPLETED
Status Verified Date:
2017-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Upper airway obstruction (UAO) during induction of general anesthesia is a frequently occurring complication. The mechanism of UAO during anesthesia shares many similarities with the upper airway obstruction observed during obstructive sleep apnea (OSA). Obesity is major risk factors for OSA and obese patients have a higher prevalence of UAO during anesthesia. The change of body position improved upper airway stability during sleep in patients with OSA.We hypothesis that the 30˚ reverse trendelenburg body position maintain airway patency in obese patients during general anesthesia.
Detailed Description:
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: