Ignite Creation Date:
2024-05-06 @ 3:55 AM
Last Modification Date:
2024-10-26 @ 11:40 AM
Study NCT ID:
NCT02405546
Status:
COMPLETED
Last Update Posted:
2016-03-23
First Post:
2015-03-24
Brief Title:
ETT Rotation During Nasal Fiberoptic Intubation
Sponsor:
Nemours Childrens Clinic
Organization:
Nemours Childrens Clinic
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2016-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 inletFollowing 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 04 mgkg 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 22 mm diameter was used for cuffed ETT MallinckrodtTM Covidien sizes 45 mm ID and under and larger FOS Olympus LF-DP 31 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 90counterclockwise 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 Fishers 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 005
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 04 mgkg 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 22 mm diameter was used for cuffed ETT MallinckrodtTM Covidien sizes 45 mm ID and under and larger FOS Olympus LF-DP 31 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 90counterclockwise 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 Fishers 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 005
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None