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Dental CariesNCT02405546

ETT Rotation During Nasal Fiberoptic Intubation

A study testing Pre-Rotated (Group R) and No pre-rotation in people with Dental Caries, run by Nemours Children's Clinic at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 2 to 17 yearsHealthy volunteers can take part
Conditions the study is for
Dental Caries
What is being tested?
Pre-Rotated (Group R) and No pre-rotation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteUnited States
Study dates
Aug 2013to Aug 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 2 to 17 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Nemours DuPont Hospital for Children

    Wilmington, Delaware, 19803

Other trials in United States

About this study

Official title: 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.

Read the 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.

Conditions
Dental Caries
Being tested
Pre-Rotated (Group R), No pre-rotation
Keywords
Nasal intubation, Counterclockwise rotation
Medical subject headings
Dental Caries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pre-Rotated (Group R)Other

    Also called 90° CCR

    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.

  • No pre-rotationOther

    ETT was not pre-rotated but rotated only if necessary

Study groups in NCT02405546
Study groupRoleWhat they receive
Pre-Rotated Technique (Group R)Experimental90° counterclockwise rotation of bevel of ETT
Receives: Other: Pre-Rotated (Group R)
No rotationActive comparatorNo rotation of bevel of ETT
Receives: Other: No pre-rotation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Whether or not ETT got hung-up at the laryngeal inlet, 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".

    Measured: Outcome will be measured Immediately

Secondary outcomes (1)
  1. 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

    Measured: Outcome will be measured Immediately after the rotation is performed

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Apr 2015 (estimated)
  2. Study startAug 2013
  3. Primary completionAug 2015
  4. Study completionAug 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Single group
Masking
Single blind
Who is masked
Care provider
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02405546
Sponsor's protocol ID
DC0001
Status last verified
Mar 2016
First submitted
24 Mar 2015
Last updated
23 Mar 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • Johnson DM, From AM, Smith RB, From RP, Maktabi MA. Endoscopic study of mechanisms of failure of endotracheal tube advancement into the trachea during awake fiberoptic orotracheal intubation. Anesthesiology. 2005 May;102(5):910-4. doi: 10.1097/00000542-200505000-00008.

    PubMed 15851876
  • Maktabi MA, Hoffman H, Funk G, From RP. Laryngeal trauma during awake fiberoptic intubation. Anesth Analg. 2002 Oct;95(4):1112-4, table of contents. doi: 10.1097/00000539-200210000-00061.

    PubMed 12351306
  • Ovassapian A, Yelich SJ, Dykes MH, Brunner EE. Fiberoptic nasotracheal intubation--incidence and causes of failure. Anesth Analg. 1983 Jul;62(7):692-5. No abstract available.

    PubMed 6859572
  • Brull SJ, Wiklund R, Ferris C, Connelly NR, Ehrenwerth J, Silverman DG. Facilitation of fiberoptic orotracheal intubation with a flexible tracheal tube. Anesth Analg. 1994 Apr;78(4):746-8. doi: 10.1213/00000539-199404000-00022.

    PubMed 8135395
  • Randell T, Hakala P, Kytta J, Kinnunen J. The relevance of clinical and radiological measurements in predicting difficulties in fibreoptic orotracheal intubation in adults. Anaesthesia. 1998 Dec;53(12):1144-7. doi: 10.1046/j.1365-2044.1998.00612.x.

    PubMed 10193214
  • Hakala P, Randell T. Comparison between two fibrescopes with different diameter insertion cords for fibreoptic intubation. Anaesthesia. 1995 Aug;50(8):735-7. doi: 10.1111/j.1365-2044.1995.tb06108.x.

    PubMed 7645711
  • Asai T, Shingu K. Difficulty in advancing a tracheal tube over a fibreoptic bronchoscope: incidence, causes and solutions. Br J Anaesth. 2004 Jun;92(6):870-81. doi: 10.1093/bja/aeh136. Epub 2004 Apr 30. No abstract available.

    PubMed 15121723
  • Kristensen MS, Moller J. Airway management behaviour, experience and knowledge among Danish anaesthesiologists--room for improvement. Acta Anaesthesiol Scand. 2001 Oct;45(9):1181-5. doi: 10.1034/j.1399-6576.2001.450921.x.

    PubMed 11683672
  • Schwartz D, Johnson C, Roberts J. A maneuver to facilitate flexible fiberoptic intubation. Anesthesiology. 1989 Sep;71(3):470-1. doi: 10.1097/00000542-198909000-00038. No abstract available.

    PubMed 2774282
  • Aoyama K, Takenaka I. Markedly displaced arytenoid cartilage during fiberoptic orotracheal intubation. Anesthesiology. 2006 Feb;104(2):378-9; author reply 379-80. doi: 10.1097/00000542-200602000-00032. No abstract available.

    PubMed 16436865

Questions about this trial

What is this clinical trial studying?

A study testing Pre-Rotated (Group R) and No pre-rotation in people with Dental Caries, run by Nemours Children's Clinic at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Whether or not ETT got hung-up at the laryngeal inlet, the 90° CCR. (time frame: Outcome will be measured Immediately). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02405546, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2016.

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