ETT Rotation During Nasal Fiberoptic Intubation
Primary Purpose
Dental Caries
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pre-Rotated (Group R)
No pre-rotation
Sponsored by
About this trial
This is an interventional diagnostic trial for Dental Caries focused on measuring Nasal intubation, Counterclockwise rotation
Eligibility Criteria
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
Sites / Locations
- Nemours DuPont Hospital for Children
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Pre-Rotated Technique (Group R)
No rotation
Arm Description
90° counterclockwise rotation of bevel of ETT
No rotation of bevel of ETT
Outcomes
Primary Outcome Measures
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".
Secondary Outcome Measures
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
Full Information
NCT ID
NCT02405546
First Posted
March 24, 2015
Last Updated
March 22, 2016
Sponsor
Nemours Children's Clinic
1. Study Identification
Unique Protocol Identification Number
NCT02405546
Brief Title
ETT Rotation During Nasal Fiberoptic Intubation
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
August 2013 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nemours Children's Clinic
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries
Keywords
Nasal intubation, Counterclockwise rotation
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pre-Rotated Technique (Group R)
Arm Type
Experimental
Arm Description
90° counterclockwise rotation of bevel of ETT
Arm Title
No rotation
Arm Type
Active Comparator
Arm Description
No rotation of bevel of ETT
Intervention Type
Other
Intervention Name(s)
Pre-Rotated (Group R)
Other Intervention Name(s)
90° CCR
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
No pre-rotation
Intervention Description
ETT was not pre-rotated but rotated only if necessary
Primary Outcome Measure Information:
Title
Whether or not ETT got hung-up at the laryngeal inlet, the 90° CCR.
Description
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".
Time Frame
Outcome will be measured Immediately
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dinesh K Choudhry, MD, FRCA
Organizational Affiliation
Nemours, DuPont Hospital for Children, Wilmington Deleware 19803
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nemours DuPont Hospital for Children
City
Wilmington
State/Province
Delaware
ZIP/Postal Code
19803
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
15851876
Citation
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Results Reference
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12351306
Citation
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.
Results Reference
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PubMed Identifier
6859572
Citation
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.
Results Reference
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PubMed Identifier
8135395
Citation
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.
Results Reference
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PubMed Identifier
10193214
Citation
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.
Results Reference
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PubMed Identifier
7645711
Citation
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Results Reference
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PubMed Identifier
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Citation
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Results Reference
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PubMed Identifier
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Citation
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Results Reference
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Citation
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.
Results Reference
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Citation
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Results Reference
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ETT Rotation During Nasal Fiberoptic Intubation
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