NCT02405546

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

March 24, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 1, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

March 23, 2016

Status Verified

March 1, 2016

Enrollment Period

2 years

First QC Date

March 24, 2015

Last Update Submit

March 22, 2016

Conditions

Dental Caries

Keywords

Nasal intubationCounterclockwise rotation

Outcome Measures

Primary Outcomes (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".

    Outcome will be measured Immediately

Secondary Outcomes (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

    Outcome will be measured Immediately after the rotation is performed

Study Arms (2)

Pre-Rotated Technique (Group R)

EXPERIMENTAL

90° counterclockwise rotation of bevel of ETT

Other: Pre-Rotated (Group R)

No rotation

ACTIVE COMPARATOR

No rotation of bevel of ETT

Other: No pre-rotation

Interventions

Pre-Rotated (Group R)OTHER

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.

Also known as: 90° CCR
Pre-Rotated Technique (Group R)
No pre-rotationOTHER

ETT was not pre-rotated but rotated only if necessary

No rotation

Eligibility Criteria

Age2 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nemours DuPont Hospital for Children

Wilmington, Delaware, 19803, United States

Location

Related Publications (10)

  • 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.

    PMID: 15851876BACKGROUND

  • 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.

    PMID: 12351306BACKGROUND

  • 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.

    PMID: 6859572BACKGROUND

  • 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.

    PMID: 8135395BACKGROUND

  • 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.

    PMID: 10193214BACKGROUND

  • 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.

    PMID: 7645711BACKGROUND

  • 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.

    PMID: 15121723BACKGROUND

  • 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.

    PMID: 11683672BACKGROUND

  • 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.

    PMID: 2774282BACKGROUND

  • 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.

    PMID: 16436865BACKGROUND

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Study Officials

  • Dinesh K Choudhry, MD, FRCA

    Nemours, DuPont Hospital for Children, Wilmington Deleware 19803

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, FRCA

Study Record Dates

First Submitted

March 24, 2015

First Posted

April 1, 2015

Study Start

August 1, 2013

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

March 23, 2016

Record last verified: 2016-03

Locations

US(1)