Comparison of Double Lumen Tube Placement Techniques
20. června 2018 aktualizováno: Igor Zhukov, Emory University
Comparison of Placement of Double-lumen Endobronchial Tube Using GlideScope With 2 Different Stylet Configurations vs Standard Macintosh Laryngoscopy
The purpose of this study is to compare three different standard of care methods of double-lumen endobronchial tube (DLT) placement in patients who are scheduled to have thoracic surgery in which lung isolation is required.
Přehled studie
Postavení
Ukončeno
Podmínky
Detailní popis
The purpose of this study is to compare three different standard of care methods of double-lumen endobronchial tube (DLT) placement in patients who are scheduled to have thoracic surgery in which lung isolation is required.
The investigators want to evaluate the technique of placement of the double-lumen endobronchial tube (DLT) using an included stylet that has been radically bent (ZU-bend) as compared to a commercial GlideRite stylet with the GlideScope and direct laryngoscopy using the Macintosh laryngoscope.
A double-lumen endobronchial tube (DLT) is a breathing tube utilized to manage the airway when lung separation is needed for a surgical procedure.
The investigator wants to evaluate how long it takes for successful placement of the double-lumen endobronchial tube (DLT) and assess the difficulty of the procedure experienced by the physician performing the intubation.
Typ studie
Intervenční
Zápis (Aktuální)
19
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
-
-
Georgia
-
Atlanta, Georgia, Spojené státy, 30322
- Emory University Hospital
-
Atlanta, Georgia, Spojené státy, 30308
- Emory University Hospital Midtown
-
-
Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
18 let a starší (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Všechno
Popis
Inclusion Criteria:
- Male and female patients requiring a double-lumen endobronchial tube placement for surgery at Emory University Hospital or Emory University Hospital Midtown
- Patients willing and able to provide written informed consent
Exclusion Criteria:
- Patients in whom a previously difficult airway manipulation was recorded on an anesthetic record
- Lung transplantation procedures, as underlying pulmonary disorder that will confound the SpO2 (peripheral capillary oxygen saturation) metric
- Any patient who is receiving anticoagulants in excess of a daily aspirin, patients with an International Normalized Ratio or INR >1
- Patients in whom one lung ventilation or placement of a double-lumen endobronchial tube is contraindicated
- Patients who require a rapid-sequence intubation
- Patients undergoing emergency procedures
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Výzkum zdravotnických služeb
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: ZU-bend stylet with GlideScope technique
Subjects scheduled for thoracic surgery in which the surgeon requests lung isolation will undergo laryngoscopy and intubation using the ZU-bend with the GlideScope technique of a double lumen endobronchial tube (DLT) placement as part of the anesthesia procedure prior to surgery.
|
Laryngoscopy and intubation after induction of anesthesia will be done using the GlideScope and the ZU-bend stylet.
The ZU-bend is a specific shaping technique of the intubating stylet that is closely related to the GlideScope blade curvature.
Zu-bend stylet is withdrawn as a part of placement procedure during the DLT advancement.
Thereafter, GlideScope is removed and placement of the double-lumen endobronchial tube is verified with capnography and fiberoptic bronchoscopy in the usual manner.
Laryngoscopy and intubation after induction of anesthesia will be done using the the GlideScope technique.
The GlideScope is a video laryngoscope that provides a real-time view of the airway and tube placement during intubation.
GlideScope is removed after DLT is in the trachea, and placement of the double-lumen endobronchial tube is verified with capnography and fiberoptic bronchoscopy in the usual manner.
|
|
Aktivní komparátor: GlideScope with the GlideRite stylet
Subjects scheduled for thoracic surgery in which the surgeon requests lung isolation will undergo laryngoscopy and intubation using the GlideScope with the GlideRite stylet for placement of a double lumen endobronchial tube (DLT) as part of the anesthesia procedure prior to surgery.
|
Laryngoscopy and intubation after induction of anesthesia will be done using the the GlideScope technique.
The GlideScope is a video laryngoscope that provides a real-time view of the airway and tube placement during intubation.
GlideScope is removed after DLT is in the trachea, and placement of the double-lumen endobronchial tube is verified with capnography and fiberoptic bronchoscopy in the usual manner.
Laryngoscopy and intubation after induction of anesthesia will be done with the GlideScope using the GlideRite stylet.
The GlideRite stylet is specifically designed to work with the GlideScope and provides the necessary rigidity and curvature to an otherwise flexible tube.
GlideRite stylet is withdrawn as a part of placement procedure during the DLT advancement.
Thereafter, GlideScope is removed and placement of the double-lumen endobronchial tube is verified with capnography and fiberoptic bronchoscopy in the usual manner.
|
|
Aktivní komparátor: Macintosh blade and a regular DLT stylet
Subjects scheduled for thoracic surgery in which the surgeon requests lung isolation will undergo laryngoscopy and intubation using the direct laryngoscopy technique with the Macintosh blade and a regular double lumen endobronchial tube (DLT) stylet as part of the anesthesia procedure prior to surgery.
|
Direct laryngoscopy and intubation after induction of anesthesia will be done with the Macintosh blade and a regular double-lumen endobronchial tube (DLT) stylet.
The Macintosh blade is used to facilitate visualization of the larynx during double or single lumen endobronchial tube placement.
After intubation the Macintosh laryngoscope is removed and the confirmation of the successful placement of the double-lumen endobronchial tube in done in the standard fashion.
Ostatní jména:
Direct laryngoscopy and intubation after induction of anesthesia will be done with a regular double-lumen endobronchial tube (DLT) stylet and the Macintosh blade.
The DLT stylet is withdrawn as a part of placement procedure during the DLT advancement.
Thereafter, Macintosh laryngoscope is removed and placement of the double-lumen endobronchial tube is verified with capnography and fiberoptic bronchoscopy in the usual manner.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Mean Time to Place the Double-lumen Endobronchial Tube
Časové okno: during laryngoscope placement, up to 120 seconds
|
The time taken for successful intubation will be recorded by the anesthetist.
The total duration from the time the laryngoscope is placed at the patient's lips to the first detection of End-tidal CO2 (EtCO2), an average of 120 seconds, will be recorded in seconds.
A higher duration noted is indicative of a longer time taken for successful intubation.
0 seconds (laryngoscope at patient's lips), (first End-tidal CO2 (EtCO2) detection)
|
during laryngoscope placement, up to 120 seconds
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Success Rate of First Endobronchial Intubation Attempt
Časové okno: during laryngoscope placement, up to 120 seconds
|
The rate of first intubation attempt success will be recorded by the anesthetist.
A successful first attempt intubation is when the double-lumen endobronchial tube is placed during the initial laryngoscopy within 120 seconds.
The average time for successful intubation is 120 seconds, which is the time from when the laryngoscope is placed at the patient's lips to the first detection of End-tidal CO2 (EtCO2).
Higher numbers of successful first attempt intubations indicate better rates of success of first endobronchial intubation attempts .
|
during laryngoscope placement, up to 120 seconds
|
|
Assessment of Difficulty of Intubation
Časové okno: during laryngoscope placement, up to 120 seconds
|
The ease of successful placement of the double-lumen endobronchial tube (DLT) will be assessed by the anesthetist's responses to a multi-question form which includes the following items that are scored; overall ease of intubation, laryngoscope insertion, glottic view, double-lumen endobronchial tube (DLT) delivery and placement.
The subjective scores range from 0-10; where 0=worst, 10=best.
The average time for successful intubation is 120 seconds, which is the time from when the laryngoscope is placed at the patient's lips to the first detection of End-tidal CO2 (EtCO2).
|
during laryngoscope placement, up to 120 seconds
|
|
Number of Cases With Complications
Časové okno: during laryngoscope placement, up to 120 seconds
|
Number of cases with complications during intubation will be will be assessed by the anesthetist's responses to a multi-question form which includes the following items; blood on device, SpO2 (peripheral capillary oxygen saturation) <96%, lip and dental trauma and double-lumen endobronchial tube (DLT) cuff rupture.
The responses are recorded as Yes or No for each item.
A 'yes' response indicates a complication.
The average time for successful intubation is 120 seconds, which is the time from when the laryngoscope is placed at the patient's lips to the first detection of End-tidal CO2 (EtCO2).
|
during laryngoscope placement, up to 120 seconds
|
|
Number of Cases of Voice Change
Časové okno: Up to 60 minutes after extubation
|
Any voice change in the patient after extubation will be assessed in the Post-Operative Admission Unit (PACU) by asking the patient if any change in voice is experienced (Yes/No).
The subjective answer given by the patient will be recorded.
The average time for the patient to sufficiently recover to respond is expected to be 60 minutes after extubation.
|
Up to 60 minutes after extubation
|
|
Throat Pain
Časové okno: Up to 60 minutes after extubation
|
Any voice change in the patient after extubation will be assessed in the Post-Operative Admission Unit (PACU) by recording the patient's response to the degree of pain experienced.
An analog pain scale will be used for scoring where: 0= no pain and 10= severe pain.
The average time for the patient to sufficiently recover to respond is expected to be 60 minutes after extubation.
|
Up to 60 minutes after extubation
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Igor Zhukov, MD, Emory University
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia
1. července 2015
Primární dokončení (Aktuální)
27. července 2017
Dokončení studie (Aktuální)
27. července 2017
Termíny zápisu do studia
První předloženo
9. července 2015
První předloženo, které splnilo kritéria kontroly kvality
10. července 2015
První zveřejněno (Odhad)
13. července 2015
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
27. července 2018
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
20. června 2018
Naposledy ověřeno
1. června 2018
Více informací
Termíny související s touto studií
Klíčová slova
Další identifikační čísla studie
- IRB00081067
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
Klinické studie na ZU-bend stylet
-
University Hospital, GrenobleUkončeno
-
University of Sao PauloDokončeno