title: Capnographic monitoring of midazolam and propofol sedation during ERCP: a randomized controlled study (EndoBreath Study).
abstract: OBJECTIVE
  This was to determine whether intervention based on additional capnographic monitoring reduces the incidence of hypoxemia during midazolam and propofol sedation for endoscopic retrograde cholangiopancreatography (ERCP).
  
  
  METHODS
  Patients (American Society of Anesthesiologists [ASA] I – IV) scheduled for ERCP under midazolam and propofol sedation were randomly assigned to a control arm with standard monitoring or an interventional arm with additional capnographic monitoring. In both arms detection of apnea prompted withholding of propofol administration, stimulation of the patient, insertion of a nasopharyngeal tube, or further measures. The primary study end point was incidence of hypoxemia (oxygen saturation [Sao 2] below 90 %); secondary end points included occurrences of severe hypoxemia (Sao 2 ≤ 85 %), bradycardia, and hypotension, and sedation quality (patient cooperation and satisfaction).
  
  
  RESULTS
  242 patients were enrolled at three German endoscopy centers. Intention-to-treat analysis revealed no significant reduction in hypoxemia incidence in the capnography arm compared with the standard arm (38.0 % vs. 44.4 %, P = 0.314). Apnea was more frequently detected in the capnography arm (64.5 % vs. 6.0 %, P < 0.001). There were no differences regarding rates of bradycardia and hypotension. Per-protocol analysis showed lower incidence of hypoxemia in the capnography arm compared with the standard arm (31.5 % vs. 44.8 %, P = 0.048). There was one death related to sedation in the standard arm. Sedation quality was similar in the two groups.
  
  
  CONCLUSIONS
  Intention-to-treat analysis showed hypoxemia incidence was not significantly lower in the additional capnography arm compared with standard monitoring. Additional capnographic monitoring of ventilatory activity resulted in improved detection of apnea.
authors.affiliation: II. Medizinische Klinik und Poliklinik, Klinikum rechts der Isar der Technischen Universität München, Germany.
authors.forename: Peter
authors.initials: P
authors.lastname: Klare
authors.affiliation: II. Medizinische Klinik und Poliklinik, Klinikum rechts der Isar der Technischen Universität München, Germany.
authors.forename: Johanna
authors.initials: J
authors.lastname: Reiter
authors.affiliation: Klinik für Innere Medizin I, Universitätsklinikum Ulm, Germany.
authors.forename: Alexander
authors.initials: A
authors.lastname: Meining
authors.affiliation: Institut für Medizinische Biometrie, Epidemiologie und Medizinische Informatik, Universität des Saarlandes, Campus Homburg, Germany.
authors.forename: Stefan
authors.initials: S
authors.lastname: Wagenpfeil
authors.affiliation: Medizinische Universitätsklinik des Knappschaftskrankenhaus der Ruhr-Universität Bochum, Germany.
authors.forename: Tim
authors.initials: T
authors.lastname: Kronshage
authors.affiliation: Medizinische Universitätsklinik des Knappschaftskrankenhaus der Ruhr-Universität Bochum, Germany.
authors.forename: Christoph
authors.initials: C
authors.lastname: Geist
authors.affiliation: Medizinische Universitätsklinik des Knappschaftskrankenhaus der Ruhr-Universität Bochum, Germany.
authors.forename: Stefan
authors.initials: S
authors.lastname: Heringlake
authors.affiliation: II. Medizinische Klinik und Poliklinik, Klinikum rechts der Isar der Technischen Universität München, Germany.
authors.forename: Christoph
authors.initials: C
authors.lastname: Schlag
authors.affiliation: II. Medizinische Klinik und Poliklinik, Klinikum rechts der Isar der Technischen Universität München, Germany.
authors.forename: Monther
authors.initials: M
authors.lastname: Bajbouj
authors.affiliation: Klinik für Anästhesie, Universitätsklinikum der Universität Witten/Herdecke, Helios Klinikum Wuppertal, Germany.
authors.forename: Gerhard
authors.initials: G
authors.lastname: Schneider
authors.affiliation: II. Medizinische Klinik und Poliklinik, Klinikum rechts der Isar der Technischen Universität München, Germany.
authors.forename: Roland M
authors.initials: RM
authors.lastname: Schmid
authors.affiliation: Fachbereich Gastroenterologie, Deutsche Klinik für Diagnostik, Helios Klinik Wiesbaden, Germany.
authors.forename: Till
authors.initials: T
authors.lastname: Wehrmann
authors.affiliation: II. Medizinische Klinik und Poliklinik, Klinikum rechts der Isar der Technischen Universität München, Germany.
authors.forename: Stefan
authors.initials: S
authors.lastname: von Delius
authors.affiliation: Medizinische Klinik, KRH Klinikum Agnes Karll, Laatzen, Germany.
authors.forename: Andrea
authors.initials: A
authors.lastname: Riphaus
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D019296:Capnography; D002760:Cholangiopancreatography, Endoscopic Retrograde / Q000379:methods*; D016292:Procedural Sedation / Q000009:adverse effects* / Q000379:methods; D005260:Female; D006801:Humans; D006993:Hypnotics and Sedatives / Q000008:administration & dosage / Q000009:adverse effects*; D000860:Hypoxia / Q000453:epidemiology / Q000209:etiology / Q000517:prevention & control*; D015994:Incidence; D057194:Intention to Treat Analysis; D008297:Male; D008874:Midazolam / Q000008:administration & dosage / Q000009:adverse effects*; D008875:Middle Aged; D008991:Monitoring, Physiologic; D010043:Outcome and Process Assessment, Health Care; D015742:Propofol / Q000008:administration & dosage / Q000009:adverse effects*
chemical_list: D006993:Hypnotics and Sedatives; D008874:Midazolam; D015742:Propofol