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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
Sponsor:
Information provided by (Responsible Party):
Yandong Jiang, Massachusetts General Hospital

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.

Condition or disease Intervention/treatment
Obese Procedure: Head up

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.


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Study Type : Observational [Patient Registry]
Actual Enrollment : 13 participants
Observational Model: Case Control
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine



Intervention Details:
  • Procedure: Head up
    30˚ reverse trendelenburg body position


Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Fifteen patients 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
Criteria

Inclusion Criteria:

BMI limited in the range of 30 kg/ m2 to 50 kg/ m2, 18-65 years of age ASA physical status classification I-III Requiring general anesthesia for elective surgery -

Exclusion Criteria:

  1. Patients with major cardiovascular disease, respiratory disease, cerebral vascular disease or American Society of Anesthesiologists physical status class IV or greater.
  2. Abnormal vital signs on the day of admission for surgery [heart rate (HR, >100 bpm or < 40 bpm), blood pressure (BP, >180/100 mmHg or < 90/60 mmHg), room air transcutaneous oxyhemoglobin saturation (SPO2) < 96%] that are not correctable with his or her routine medication or commonly used pre-operative medication.
  3. Having claustrophobia and not able to tolerate the mask.
  4. Any person with an anticipated difficult airway or those with a history of difficult airway who requires a fiberoptic intubation while awake.
  5. Gastric-esophageal reflex disease that is refractory to treatment or a full stomach.
  6. The subject has been in bed for more than 24 hours.
  7. Neurological symptoms associated with neck extension, a neurological deficit from a previous stroke or spinal cord injury, a recent stroke or transient ischemic attack (TIA) within 2 weeks.
  8. Pregnant women and women less than one month post-partum. Ruling out pregnancy will be conducted by careful history and physical examination as performed routinely prior to 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.
  9. Emergency cases and subjects who have not adhered to the ASA NPO (Nil Per Os) guidelines.

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Information from the National Library of Medicine

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


Locations
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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
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Principal Investigator: Yandong Jiang, MD, PhD Massachusetts General Hospital

Additional Information:

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Responsible Party: Yandong Jiang, Dr., Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01811069     History of Changes
Other Study ID Numbers: 2012p-002632
First Posted: March 14, 2013    Key Record Dates
Last Update Posted: January 18, 2017
Last Verified: January 2017
Keywords provided by Yandong Jiang, Massachusetts General Hospital:
Obese patients
Upper airway patency
Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs