Effect of Upright Patient Positioning on Intubation Success

August 30, 2016 updated by: Joseph Turner, Indiana University

Prospective Observational Study of the Effect of Upright Patient Positioning on Intubation Success Rates at Two Academic Emergency Departments

Endotracheal intubation is most commonly taught and performed with the patient supine. Recent literature suggests that elevating the patient's head to a more upright position may decrease peri-intubation complications. However, there is little data on success rates of upright intubation in the emergency department. The goal of this study was to measure the association of head positioning with intubation success rates among emergency medicine residents.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Endotracheal intubation is most commonly taught and performed with the patient supine. Recent literature suggests that elevating the patient's head to a more upright position may decrease peri-intubation complications. However, there is little data on success rates of upright intubation in the emergency department. The goal of this study was to measure the association of head positioning with intubation success rates among emergency medicine residents. Study design was a prospective observational study. Residents performing intubation recorded the angle of the head of the bed, and the number of attempts required for successful intubation was recorded by faculty and respiratory therapists. The primary outcome of first past success was calculated with respect to three groups: 0-10 degrees (supine), 11-44 degrees (inclined), and ≥45 degrees (upright); first past success was also analyzed in 5 degree angle increments.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
232

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Intubation events that were eligible for enrollment included adult medical intubations performed at participating hospitals in which the intubating resident and supervising faculty both consented to study participation.

Description

Inclusion Criteria:

  • Adult medical intubations in which the intubating resident and supervising faculty both consented to study participation.

Exclusion Criteria:

  • Pediatric patients
  • Obstetric patients
  • Trauma patients

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Supine intubations (0-10 degrees)
Intubations performed with patient positioned 0-10 degrees. Patient supine.
Procedure: Upright intubation
Upright Intubation procedure performed with patient elevated above the supine position. Defined as upright greater to or equal to 45 degrees or inclined 10-44 degrees
Inclined (11-44 degrees)
Intubations performed with 11-44 degrees of elevation.
Procedure: Upright intubation
Upright Intubation procedure performed with patient elevated above the supine position. Defined as upright greater to or equal to 45 degrees or inclined 10-44 degrees
Upright (45 degrees or greater)
intubations performed with patient elevated to 45 degrees or greater
Procedure: Upright intubation
Upright Intubation procedure performed with patient elevated above the supine position. Defined as upright greater to or equal to 45 degrees or inclined 10-44 degrees

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
First Pass Success
Time Frame: Immediately at the time of the procedure
An attempt was defined as anytime the laryngoscope blade was placed in the patient's mouth. At the beginning of the study residents, faculty, and RTs were educated on this definition.
Immediately at the time of the procedure

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
overall success rate of orotracheal intubation overall success rate of orotracheal intubation overall success rate of intubation
Time Frame: Immediately at the time of the procedure
endotracheal tube in place
Immediately at the time of the procedure
Time required for successful intubation
Time Frame: Immediately at the time of the procedure
endotracheal tube in place
Immediately at the time of the procedure
esophageal intubation
Time Frame: Immediately at the time of the procedure
endotracheal tube determined to be positioned in esophagus rather
Immediately at the time of the procedure
cardiac arrest within 30 minutes of the intubation attempt
Time Frame: cardiac arrest within 30 minutes of intubation
cardiac arrest within 30 minutes of intubation
decrease in oxygen saturation during the procedure
Time Frame: Immediately at the time of the procedure
Immediately at the time of the procedure
best Cormack-Lehane view
Time Frame: Immediately at the time of the procedure
Cormack-Lehane view is a scale that is used to describe the amount of vocal cords visualized during the procedure
Immediately at the time of the procedure
best Percent of Glottic Opening (POGO)
Time Frame: obtained during the procedure
Percent of glottis opening refers to the percentage of vocal cords and surrounding anatomy which can be seen during the procedure
obtained during the procedure
Resident Satisfaction with Positioning
Time Frame: following procedure
survey completed following the procedure by provider regarding satisfaction
following procedure
death in ED
Time Frame: While in the emergency department (1 hour up to 1 day)
While in the emergency department (1 hour up to 1 day)
death within 5 days of intubation
Time Frame: Death within 5 days following intubation
any cause of death within 5 days after intubation
Death within 5 days following intubation
New pneumonia
Time Frame: within 5 days following intubation
new pneumonia developed within 5 days following an intubation. Not present on admission.
within 5 days following intubation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Indiana University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Joseph Turner, MD, Indiana University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 24, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 30, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 31, 2016

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 31, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 30, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1405954059

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Study Data/Documents

  1. Study Protocol
    Information comments: Study protocol can be provided via email if requested. Please email turnjose@iu.edu

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.

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