- ICH GCP
- US-Register für klinische Studien
- Klinische Studie 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.
Studienübersicht
Status
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Voraussichtlich)
Kontakte und Standorte
Studienorte
-
-
Massachusetts
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Boston, Massachusetts, Vereinigte Staaten, 02215
- Rekrutierung
- Brigham and Women's Hospital
-
Kontakt:
- Anthony Chau, MD
- Telefonnummer: 617-732-5500
- E-Mail: achau2@partners.org
-
Hauptermittler:
- Lawrence Tsen, MD
-
Unterermittler:
- Anthony Chau, MD
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Unterermittler:
- Carolina Bibbo, MD
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Unterermittler:
- Julian Robinson, MD
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Unterermittler:
- Eric Cappiello, MD
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Kind
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
|---|
|
Pregnant patient
Pregnant woman presenting for vaginal or cesarean delivery
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
|
incidence of difficult regional and general anesthesia
Zeitfenster: within 30 days
|
within 30 days
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Lawrence C Tsen, MD, Brigham and Women's Hospital
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- 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.
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Voraussichtlich)
Studienabschluss (Voraussichtlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- bwhobanes-DADB
Plan für individuelle Teilnehmerdaten (IPD)
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Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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