PURPOSE: The efficacy of noninvasive ventilation (NIV) during procedures that require sedation and analgesia has not been established. We evaluated whether NIV reduces the incidence of respiratory events. METHODS: In this randomized controlled trial, we included 195 patients with an American Society of Anesthesiologists Physical Status of III or IV during electrophysiology laboratory procedures. We compared NIV with face mask oxygen therapy for patients under sedation. The primary outcome was the incidence of respiratory events determined by a computer-driven blinded analysis and defined by hypoxemia (peripheral oxygen saturation < 90%) or apnea/hypopnea (absence of breathing for 20 sec on capnography). Secondary outcomes included hemodynamic variables, sedation, patient safety (composite scores of major or minor adverse events), and adverse outcomes at day 7. RESULTS: A respiratory event occurred in 89/98 (95%) patients in the NIV group and in 69/97 (73%) patients with face masks (risk ratio [RR], 1.29; 95% confidence interval [CI], 1.13 to 1.47; P < 0.001). Hypoxemia occurred in 40 (42%) patients in the NIV group and in 33 (34%) patients with face masks (RR, 1.21; 95% CI, 0.84 to 1.74; P = 0.30). Apnea/hypopnea occurred in 83 patients (92%) in the NIV group vs 65 patients (70%) with face masks (RR, 1.32; 95% CI, 1.14 to 1.53; P < 0.001). Hemodynamic variables, sedation, major or minor safety events, and patient outcomes were not different between the groups. CONCLUSIONS: Respiratory events were more frequent among patients receiving NIV without any safety or outcome impairment. These results do not support the routine use of NIV intraoperatively. STUDY REGISTRATION: ClinicalTrials.gov (NCT02779998); registered 4 November 2015.
RéSUMé: OBJECTIF: L'efficacité de la ventilation non invasive (VNI) pendant les interventions nécessitant une sédation et une analgésie n'a pas été établie. Nous avons évalué si la VNI réduisait l'incidence des complications respiratoires. MéTHODE: Dans cette étude randomisée contrôlée, nous avons inclus 195 patient·es de statut physique III ou IV selon l'American Society of Anesthesiologists pendant des interventions en laboratoire d'électrophysiologie. Nous avons comparé la VNI à l'oxygénothérapie par masque facial pour les patient·es sous sédation. Le critère d'évaluation principal était l'incidence des complications respiratoires déterminée par une analyse en aveugle assistée par ordinateur et définie par une hypoxémie (saturation périphérique en oxygène < 90 %) ou une apnée/hypopnée (absence de respiration pendant 20 secondes à la capnographie). Les critères d'évaluation secondaires comprenaient les variables hémodynamiques, la sédation, la sécurité des patient·es (scores composites des événements indésirables majeurs ou mineurs) et les issues indésirables au jour 7. RéSULTATS: Un événement respiratoire est survenu chez 89/98 (95 %) patient·es du groupe VNI et chez 69/97 (73 %) patient·es ayant un masque facial (risque relatif [RR], 1,29; intervalle de confiance [IC] à 95 %, 1,13 à 1,47; P < 0,001). Une hypoxémie est survenue chez 40 (42 %) patient·es du groupe VNI et chez 33 (34 %) patient·es ayant un masque facial (RR, 1,21 ; IC à 95 %, 0,84 à 1,74; P = 0,30). Une hypoxémie est survenue chez 40 (42 %) patient·es du groupe VNI et chez 33 (34 %) patient·es ayant un masque facial (RR, 1,21; IC 95 %, 0,84 à 1,74; P = 0,30). Les variables hémodynamiques, la sédation, les événements de sécurité majeurs ou mineurs et les issues pour les patient·es n'étaient pas différents entre les groupes. CONCLUSION: Les complications respiratoires étaient plus fréquentes chez les patient·es recevant une VNI sans aucun impact sur la sécurité ou les issues. Ces résultats n'appuient pas l'utilisation systématique de la VNI en peropératoire. ENREGISTREMENT DE L'éTUDE: ClinicalTrials.gov (NCT02779998); enregistrée le 4 novembre 2015.
Noninvasive Ventilation , Respiration Disorders , Respiratory Insufficiency , Humans , Noninvasive Ventilation/methods , Masks/adverse effects , Apnea , Hypoxia/epidemiology , Hypoxia/etiology , Hypoxia/prevention & control , Oxygen , Electrophysiology , Respiratory Insufficiency/therapy
BACKGROUND: Implantation of cardiovascular implantable electronic devices (CIEDs) has greatly increased during the last decade and anaesthetic management of these patients remains an open question. OBJECTIVE: This study describes anaesthetic management and risk factors associated with complications occurring during these procedures. DESIGN: A single-centre prospective observational study. SETTING: Grenoble University Hospital, France, from May 2010 to October 2010. PATIENTS: All patients admitted to the cardiac electrophysiology laboratory were included. INTERVENTION: None. MAIN OUTCOME MEASURES: Clinical data, anaesthetic and medical characteristics as well as complications (respiratory or cardiovascular) and treatment were recorded by the anaesthetic nurse at the end of each procedure. RESULTS: Two hundred and sixty-nine patients were included, 229 (85%) with an American Society of Anaesthesiologists (ASA) status of 3 or 4, 103 (38%) with a New York Heart Association (NYHA) functional class of 3 or 4 and 136 (51%) with a left ventricular ejection fraction of less than 40%. Two hundred and forty-seven (92%) of the patients underwent deep sedation and 12 (8%) general anaesthesia. Seventy-eight (29%) patients had at least one complication, among whom 21 (27%) had at least one considered as severe. Fifty (19%) of the patients had a respiratory complication and 46 (17%) a cardiovascular complication; the latter was more frequently severe (41 vs. 12%; P=0.001). Lead extraction [odds ratio (OR) 13.7, 95% confidence interval (CI) 3.5 to 53.3; P<0.001], NYHA status of 4 (OR 11.8, 95% CI 1.8 to 74.8; P<0.001), implantable cardioverter-defibrillator (ICD) testing by T-wave shock (OR 3.9, 95% CI 1.53 to 10.2; P=0.005) and length of procedure (OR 1.01, 95% CI 1.004 to 1.031; P=0.013) were identified as independent risk factors for cardiovascular complications. CONCLUSION: Patients requiring cardiovascular implantable electronic device (CIED) implantation were fragile with a high complication rate and a high rate of severe complications even with anaesthesiological support. These complications, as well as the need for deep sedation or general anaesthesia, clearly justify the involvement of a qualified anaesthesiologist.
Anesthesiology/methods , Cardiac Electrophysiology/methods , Defibrillators, Implantable/adverse effects , Aged , Anesthesia/methods , Cohort Studies , Death, Sudden, Cardiac/etiology , Female , Heart Failure/complications , Heart Failure/therapy , Humans , Male , Middle Aged , Prospective Studies , Risk Factors , Treatment Outcome
