- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT02193542
Incidence of Difficult Airway and Difficult Neuraxial Placement in Obstetric Patients (DADB)
Prospective Observation Study of Incidence of Difficult Airway and Difficult Neuraxial Placement in Obstetric Patients
Anesthesiologists commonly administer pain relief during labor or providing anesthesia for cesarean delivery. Two main methods are used to achieve these goal: "Regional anesthesia" where the mother is given medication through a needle or catheter in her back and the mother is kept awake, or "General anesthesia", where the mother is given intravenous medication and is kept asleep.
Regional anesthesia uses a needle to enter a narrow space in the mother's back where medications can be given. In some patients, it takes longer to find this target space in the back. In emergency situation, however, there is often little time to find this space, and the backup method would be the general anesthesia technique.
If general anesthesia is required, a breathing tube needs to be inserted to help support the mother's breathing. In some patients, it is harder to insert the breathing tubes, so knowing this in advanced helps anesthesiologists create a safe plan for the patients. A lot of research has been done to determine factors that would predict which patients would need more time and preparation for general anesthesia and regional anesthesia.
The purpose of this study is to study how common it is for the pregnant patients who have a difficult regional and general anesthesia.
Studie Overzicht
Toestand
Gedetailleerde beschrijving
Anesthesiologists commonly administer pain relief during labor or providing anesthesia for cesarean delivery. Two main methods are used to achieve these goal: "Regional anesthesia" where the mother is given medication through a needle or catheter in her back and the mother is kept awake, or "General anesthesia", where the mother is given intravenous medication and is kept asleep.
Regional anesthesia uses a needle to enter a narrow space in the mother's back where medications can be given. In some patients, it takes longer to find this target space in the back. In emergency situation, however, there is often little time to find this space, and the backup method would be the general anesthesia technique.
If general anesthesia is required, a breathing tube needs to be inserted to help support the mother's breathing. In some patients, it is harder to insert the breathing tubes, so knowing this in advanced helps anesthesiologists create a safe plan for the patients. A lot of research has been done to determine factors that would predict which patients would need more time and preparation for general anesthesia and regional anesthesia.
The purpose of this study is to study how common it is for the pregnant patients who have a difficult regional and general anesthesia.
Studietype
Inschrijving (Geschat)
Contacten en locaties
Studie Locaties
-
-
Massachusetts
-
Boston, Massachusetts, Verenigde Staten, 02215
- Werving
- Brigham and Women's Hospital
-
Contact:
- Anthony Chau, MD
- Telefoonnummer: 617-732-5500
- E-mail: achau2@partners.org
-
Hoofdonderzoeker:
- Lawrence Tsen, MD
-
Onderonderzoeker:
- Anthony Chau, MD
-
Onderonderzoeker:
- Carolina Bibbo, MD
-
Onderonderzoeker:
- Julian Robinson, MD
-
Onderonderzoeker:
- Eric Cappiello, MD
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Kind
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Bemonsteringsmethode
Studie Bevolking
Beschrijving
Inclusion Criteria:
- Pregnant woman presenting for vaginal or cesarean delivery
Exclusion Criteria:
- Pregnant woman presenting for vaginal or cesarean delivery requiring urgent or emergent delivery
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
|---|
|
Pregnant patient
Pregnant woman presenting for vaginal or cesarean delivery
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
|
incidence of difficult regional and general anesthesia
Tijdsspanne: within 30 days
|
within 30 days
|
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Lawrence C Tsen, MD, Brigham and Women's Hospital
Publicaties en nuttige links
Algemene publicaties
- Bucklin BA, Hawkins JL, Anderson JR, Ullrich FA. Obstetric anesthesia workforce survey: twenty-year update. Anesthesiology. 2005 Sep;103(3):645-53. doi: 10.1097/00000542-200509000-00030. No abstract available.
- Hawkins JL. Anesthesia-related maternal mortality. Clin Obstet Gynecol. 2003 Sep;46(3):679-87. doi: 10.1097/00003081-200309000-00020. No abstract available.
- Ross BK. ASA closed claims in obstetrics: lessons learned. Anesthesiol Clin North Am. 2003 Mar;21(1):183-97. doi: 10.1016/s0889-8537(02)00051-2.
- Ellinas EH, Eastwood DC, Patel SN, Maitra-D'Cruze AM, Ebert TJ. The effect of obesity on neuraxial technique difficulty in pregnant patients: a prospective, observational study. Anesth Analg. 2009 Oct;109(4):1225-31. doi: 10.1213/ANE.0b013e3181b5a1d2.
- Fettes PD, Jansson JR, Wildsmith JA. Failed spinal anaesthesia: mechanisms, management, and prevention. Br J Anaesth. 2009 Jun;102(6):739-48. doi: 10.1093/bja/aep096. Epub 2009 May 6.
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Geschat)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Andere studie-ID-nummers
- bwhobanes-DADB
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .