ETT Rotation During Nasal Fiberoptic Intubation

March 22, 2016 updated by: Dinesh Choudhry, Nemours Children's Clinic

Effect of 90° Degree Counterclockwise Rotation of the Endotracheal Tube on Its Advancement Through the Larynx During Nasal Fiberoptic Intubation in Children: A Randomized and Blinded Study

A nasal endotracheal tube (ETT) is routinely placed in children and a fiberoptic scope (FOS) is commonly used for this purpose. Resistance to the passage of ETT is frequently encountered as it is advanced over the FOS for placement into the trachea, since it gets hung up on structures of the laryngeal inlet. The aim of the investigators study performed on forty children divided in two groups was to study in the pediatric population, whether a 90° counterclockwise rotation (CCR) of the ETT prior to advancing through the larynx, by nasal approach, prevents it from getting hung up at the laryngeal inlet.

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

A nasal endotracheal tube (ETT) is routinely placed in children and a fiberoptic scope (FOS) is commonly used for this purpose. Resistance to the passage of ETT is frequently encountered as it is advanced over the FOS for placement into the trachea, since it gets hung up on structures of the laryngeal inlet. The aim of the investigators study performed on forty children divided in two groups was to study in the pediatric population, whether a 90° counterclockwise rotation (CCR) of the ETT prior to advancing through the larynx, by nasal approach, prevents it from getting hung up at the laryngeal inlet.Following the approval of Nemours Institutional Review Board, and informed consent, forty healthy children were included in the study.

All children were randomly assigned to one of two groups using a computer generated numbers table. Group-S (Standard technique): It involved placement of ETT over the FOS with bevel of the ETT facing left as is routinely done Group-R (pre-Rotated technique): It involved placement of ETT over the FOS with 90° CCR from the beginning so that the bevel of the ETT faced posteriorly.

All children received midazolam premedication prior to coming to the operating room and were anesthetized by a standard technique using mask induction with oxygen, nitrous oxide and sevoflurane. Intravenous line was placed and rocuronium 0.4 mg/kg body weight was then administered to achieve muscle relaxation. Oxymetazoline hydrochloride lotion (Afrin) was sprayed in both nostrils to achieve nasal mucosal decongestion and the ETT of appropriate size for that age was used for nasotracheal intubation. Small FOS (Olympus LF-P; 2.2 mm diameter) was used for cuffed ETT (MallinckrodtTM; Covidien) sizes 4.5 mm ID and under and larger FOS (Olympus LF-DP; 3.1 mm diameter) was used for cuffed ETT (MallinckrodtTM; Covidien) sizes 5 mm ID and over. ETT was mounted on a FOS and secured near the proximal end close to the eyepiece. With head maintained in neutral position, a lubricated FOS was then advanced through the right or left nostril (the one that looked bigger) into the larynx and once in the trachea, the lubricated ETT was advanced over it.

An unblinded anesthesia attending associated with the study prepared the FOS and ETT according to the randomization, and advanced the FOS into the trachea and the ETT into the posterior pharynx. The anesthesia provider advancing the ETT was always one of the trainees: student nurse anesthetists (SRNA) or resident who was not a part of the study and was blinded to whether or not the ETT has been rotated 90°counterclockwise. The attending member of the research team observed as the ETT was advanced by the trainee and made a note of whether or not the ETT got hung up. If it did, the research team member withdrew the ETT 2 cm, rotated it 90° CCR, and allowed the trainee to advance the ETT one or more times, noting the results.

Following parameters would be measured:

Demographic data: age, weight, sex, nostril used and FOS size used; Whether or not ETT got hung-up at the laryngeal inlet, Whether or not 90° counterclockwise rotation was helpful with ETT advancement through the larynx and number of attempts needed to successfully advance the ETT after the 90° CCR.

Definition of resistance to tube advancement (hung-up ETT):

Steady but gentle force is generally needed to advance an ETT over the FOS, first through the nose and then into the trachea through the larynx. If the ETT were to pass smoothly no change in force is generally needed as it goes through the larynx. During advancement over the FOS, if ETT came to an abrupt stop and then the same steady force was insufficient to advance the ETT through the larynx it was defined as "hung up". If sudden resistance to passage through the larynx was encountered indicating that the ETT is hung up at the laryngeal inlet, it was then withdrawn about 2 cm, rotated 90° counterclockwise and readvanced through the larynx and observation was made if CCR maneuver leads to smoother passage of the ETT through the larynx into the trachea without it getting hung-up.

Statistical analysis: The data will be analyzed in the following manner: Nominal data such as gender, nostril used and FOS size compared between the groups using Fisher's exact test and numeric data such as age and weight with independent sample t-test. Outcome data such as presence or absence of resistance due to hung up ETT will be analyzed with Chi square while number of attempts will be analyzed with t-test. Significance was assumed at P< 0.05.

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.
Interventional

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.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Delaware
      • Wilmington, Delaware, United States, 19803
        • Nemours DuPont Hospital for Children

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

2 years to 17 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • American Society of Anesthesiologists physical status 1 and 2
  • Between 2 up to 18 years of age
  • Normal airway anatomy
  • scheduled for oral rehabilitation procedure

Exclusion Criteria:

  • Children less than 2 years of age
  • Abnormal airway and facial anatomy
  • American Society of Anesthesiologists physical status 3 and 4
  • Coagulation disorders were excluded from the study

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

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
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.
Experimental: Pre-Rotated Technique (Group R)
90° counterclockwise rotation of bevel of ETT
Other: Pre-Rotated (Group R)
In group R, placement of ETT over the FOS was done with 90° CCR from the beginning so that the bevel of the ETT faced posteriorly before it was advanced through the larynx.
Other Names:
  • 90° CCR
Active Comparator: No rotation
No rotation of bevel of ETT
Other: No pre-rotation
ETT was not pre-rotated but rotated only if necessary

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
Whether or not ETT got hung-up at the laryngeal inlet, the 90° CCR.
Time Frame: Outcome will be measured Immediately
Definition of resistance to tube advancement (hung-up ETT): Steady but gentle force is generally needed to advance an ETT over the FOS, first through the nose and then into the trachea through the larynx. If the ETT were to pass smoothly no change in force is generally needed as it goes through the larynx. During advancement over the FOS, if ETT came to an abrupt stop and then the same steady force was insufficient to advance the ETT through the larynx it was defined as "hung up".
Outcome will be measured Immediately

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
Time Frame
Whether or not 90° counterclockwise rotation was helpful with ETT advancement through the larynx and number of attempts needed to successfully advance the ETT after
Time Frame: Outcome will be measured Immediately after the rotation is performed
Outcome will be measured Immediately after the rotation is performed

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.
Nemours Children's Clinic

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: Dinesh K Choudhry, MD, FRCA, Nemours, DuPont Hospital for Children, Wilmington Deleware 19803

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

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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.
August 1, 2013

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.
August 1, 2015

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.
August 1, 2015

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).
March 24, 2015

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.
March 27, 2015

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.
April 1, 2015

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.
March 23, 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.
March 22, 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.
March 1, 2016

More Information

Terms related to this study

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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.
  • DC0001

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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