← Back to Search

Head Elevated Positioning Device for Pregnancy-Related Airway Management

N/A

Waitlist Available

Led By Naveed Siddiqui, MD

Research Sponsored by Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 10 min

Awards & highlights

Study Summary

This trial will help determine if the TROOP elevation pillow ® is an effective device for airway management in the obese pregnant patient and will also help to optimize patient positioning.

Who is the study for?

This trial is for morbidly obese pregnant women in their third trimester (beyond 28 weeks). Participants must understand the study and consent to it. They should be able to participate safely and comfortably. Women with previous neck surgery, cervical spine issues, or upper limb neurology are excluded.Check my eligibility

What is being tested?

The trial is testing how a head elevating device called TROOP elevation pillow ® affects the position, height, and depth of the cricothyroid membrane during airway management in obese pregnant patients compared to no device use.See study design

What are the potential side effects?

There may not be direct side effects from using the TROOP elevation pillow ® itself; however, discomfort or difficulty in positioning due to obesity might occur during ultrasound assessment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 10 min

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~10 min

This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 min for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

The change in the CTM midpoint between neutral positioning and the head elevated position.

Secondary outcome measures

The change in depth of the CTM between neutral positioning and the head elevated.

The change in distance from the sternal notch to the CTM mid-point between neutral positioning and the head elevated.

The change in height of the CTM between neutral positioning and the head elevated.

Trial Design

1Treatment groups

Experimental Treatment

Group I: UltrasoundExperimental Treatment1 Intervention

Ultrasound measurements of the cricothyroid membrane

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ultrasound

2013

Completed Phase 1

~1950

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Samuel Lunenfeld Research Institute, Mount Sinai HospitalLead Sponsor

127 Previous Clinical Trials

11,207 Total Patients Enrolled

Naveed Siddiqui, MDPrincipal InvestigatorMOUNT SINAI HOSPITAL

6 Previous Clinical Trials

543 Total Patients Enrolled

Media Library

Ultrasound Clinical Trial Eligibility Overview. Trial Name: NCT04569539 — N/A

Airway Complication Research Study Groups: Ultrasound

Airway Complication Clinical Trial 2023: Ultrasound Highlights & Side Effects. Trial Name: NCT04569539 — N/A

Ultrasound 2023 Treatment Timeline for Medical Study. Trial Name: NCT04569539 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this investigation actively enrolling participants?

"Absolutely. Clinicaltrials.gov displays that this clinical trail, which was originally launched on September 24th 2020, is currently recruiting patients. 50 participants need to be drawn from a single medical centre."

Answered by AI

Who is eligible to partake in this clinical experiment?

"This clinical trial seeks 50 applicants meeting the following criteria: Morbid Obesity (BMI≥40kg/m2), Pregnant patients in third trimester (>28/40 weeks) and must be between ages 18 to 50. Additionally, participants must comprehend the rationale of assessments as well as having the capacity to provide consent for participation."

Answered by AI

What is the scope of participation for this clinical trial?

"Indeed, clinicaltrials.gov demonstrates that this medical trial is open for enrollment. It was first publicized on September 24th 2020 and the most recent update took place on August 19th 2022. The study seeks to acquire data from 50 participants at a single site."

Answered by AI

Does this research endeavor accept applicants who are 25 and older?

"The eligibility criteria for this study necessitate that participants fall between 18 and 50 years of age. There are individual trials available to those less than 18 or older than 65, however these will require separate applications."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

The Effect of a Head Elevated Positioning Device on Position, Height and Depth of the Cricothyroid Membrane in Morbidly Obese Pregnant Women in the Third Trimester.

2020. "The Effect of a Head Elevated Positioning Device on Position, Height and Depth of the Cricothyroid Membrane in Morbidly Obese Pregnant Women in the Third Trimester.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04569539.