- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04716218
Effect of Back up Head Elevated Position on Laryngeal Visualization.
Effect of Back up Head Elevated Position on Laryngeal Visualization With the Video-laryngoscope in Patients With Simulated Difficult Airway.
In patients with limited neck extension and mouth opening due to reasons including previous radiation therapy in the head and neck area or cervical spine pathology, tracheal intubation with direct laryngoscopy (DL) are challenging because of the difficulty in aligning the oral, pharyngeal, and laryngeal axes in order to visualize the cords. In contrast, video-laryngoscopes (VL) only require alignment of the pharyngeal and laryngeal axes, which lie along much more similar angles when compared with the oral axis. Thus, VL make tracheal intubation easier to accomplish in these patients.
Good patient positioning also maximizes the chance of successful laryngoscopy and tracheal intubation. In difficult airway society 2015 guidelines, advantages of head-up positioning and ramping, which brings the patient's sternum onto the horizontal plane of the external auditory meatus (EAM), are highlighted. In the obese patient, the 'ramped' position should be used routinely because this improves the view during DL. This position is usually achieved by placing blankets or other devices under the patient's head and shoulders, but can also be achieved simply by configuring the operation room (OR) table into a back-up head elevated (BUHE) position. Significantly improved glottic views on DL have been reported with both obese and non-obese adult patients in BUHE position. However, the effect of this simple maneuver on laryngeal visualization with the VL in patients with limited neck extension and mouth opening has not been reported.
The investigators hypothesized that BUHE position might improve laryngeal views and make intubation easier compared to the supine position with the VL in patients with simulated difficult airway (application of a cervical collar to limit mouth opening and neck movement).The investigator investigated primarily the improvement in visualization of the glottis and, secondarily, the ease of tracheal intubation after alignment of the EAM and sternal notch.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Joo Hyun Jun, MD, PhD
- Phone Number: +82-2-829-5740
- Email: ilpleut@naver.com
Study Locations
-
-
-
Seoul, Korea, Republic of
- Recruiting
- Kangnam Sacred Heart Hospital, Hallym University College of Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- patients of ASA physical status 1-2 who were scheduled for elective surgery under general anaesthesia requiring tracheal intubation
Exclusion Criteria:
- if they required rapid sequence induction; had a history of previous difficult direct laryngoscopy and required awake tracheal intubation; were unable or unwilling to provide informed consent; had uncontrolled hypertension; had a history of ischaemic heart disease without optimal control of symptoms; had a history of acute or recent stroke or myocardial infarction; had cervical spine instability or cervical myelopathy; had symptomatic asthma or reactive airway disease requiring daily pharmacological treatment for control of symptoms; or had a history of gastric reflux.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: neutral position
The initial percentage of glottic opening (POGO) by laryngoscopy was recorded in the ramped position.
Thereafter, a second POGO (laryngeal view) was scored in the neutral position and then intubation was performed.
|
The patient was then placed in the back-up position to align the external auditory meatus and sternal notch, which was achieved by breaking the operating table at the hips to prevent patients from sliding off the table.
|
Experimental: back up head elevated position
The initial POGO was recorded in the neutral position.
The second POGO was scored in the ramped position and then the trachea was intubated.
|
The patient was then placed in the back-up position to align the external auditory meatus and sternal notch, which was achieved by breaking the operating table at the hips to prevent patients from sliding off the table.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
POGO score
Time Frame: During laryngeal visualization by laryngoscope over 1 minute period
|
percentage of glottic opening
|
During laryngeal visualization by laryngoscope over 1 minute period
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
ease of tracheal intubation
Time Frame: The time from the insertion of laryngoscope into oral cavity until tracheal intubation over 1minute period
|
number of optimization procedure to facilitate laryngeal visualization and tracheal intubation
|
The time from the insertion of laryngoscope into oral cavity until tracheal intubation over 1minute period
|
intubation time
Time Frame: The time from the insertion of laryngoscope into oral cavity until its removal over 1 minute period
|
time required for intubation
|
The time from the insertion of laryngoscope into oral cavity until its removal over 1 minute period
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2020-09-009
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Intubation;Difficult
-
Lazarski UniversityCompletedIntubation; Difficult or Failed | Difficult Airway | Intubation;DifficultPoland
-
Catharina Ziekenhuis EindhovenCompletedAnesthesia Intubation Complication | Intubation; Difficult | Failed or Difficult Intubation | Failed or Difficult Intubation, Initial EncounterNetherlands
-
Michael MaRecruitingDifficult Intubation | Difficult Airway IntubationIreland
-
Children's Hospital of PhiladelphiaEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsCompletedIntubation Complication | Intubation;Difficult | Failed or Difficult Intubation, SequelaUnited States, Canada, Singapore
-
Children's Hospital of PhiladelphiaAgency for Healthcare Research and Quality (AHRQ)RecruitingIntubation Complication | Intubation; Difficult | Failed or Difficult Intubation, SequelaUnited States, Canada, Japan, Italy, New Zealand, Singapore, Australia, Austria, Germany, India, United Kingdom
-
J. Matthias WalzTerminatedSurgery | Difficult Intubation | Anesthesia | Difficult Airway Intubation | Speech DysfunctionUnited States
-
Derince Training and Research HospitalCompletedDifficult Intubation | Difficult AirwayTurkey
-
University at BuffaloTerminatedIntubation Complication | Intubation;DifficultUnited States
-
University Hospitals Coventry and Warwickshire...Oxford University Hospitals NHS TrustCompletedIntubation;Difficult | Tracheal IntubationUnited Kingdom
-
Heinrich-Heine University, DuesseldorfCompleted
Clinical Trials on back up head elevated position
-
Hallym University Kangnam Sacred Heart HospitalNot yet recruitingIntubation; Difficult or Failed
-
University of MalayaRecruitingPaediatric Airway ManagementMalaysia
-
Children's Hospital of Fudan UniversityCompletedApnea of Prematurity
-
University of Kansas Medical CenterCompletedGeneral SurgeryUnited States
-
Mount Sinai Hospital, CanadaNot yet recruiting
-
B.P. Koirala Institute of Health SciencesCompleted
-
University of Kansas Medical CenterCompletedEvaluation of Apnea Tolerance in Bariatric Patients Following Rapid-sequence Induction of AnesthesiaGeneral SurgeryUnited States
-
University of MalayaCompletedBed up Head Elevated Intubation PositionMalaysia
-
Red Salud Materno Infantil y del DesarrolloHospital Universitario 12 de OctubreCompletedNeonatal DisorderSpain
-
Massachusetts General HospitalCompletedSleep Disordered Breathing | Upper Airway Obstruction | Upper Airway CollapsibilityUnited States