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1. Feasibility of remote digital monitoring using wireless Bluetooth monitors, the Smart Angel™ app and an original web platform for patients following outpatient surgery: a prospective observational pilot study

Author

Thierry Chevallier, Gautier Buzancais, Bob-Valéry Occean, Pierre Rataboul, Christophe Boisson, Natacha Simon, Ariane Lannelongue, Noémie Chaniaud, Yann Gricourt, Jean-Yves Lefrant, and Philippe Cuvillon

Subjects
Ambulatory surgery, Remote monitoring, Device, Usability, Anesthesiology, RD78.3-87.3
Abstract

Abstract Background Remote monitoring of mean arterial blood pressure (MAP), heart rate (HR) or oxygen saturation (SpO2) remains a challenge in outpatient surgery. This study evaluates a new digital technology (Smart Angel™) for remotely monitoring hemodynamic data in real time: data transmitted from the patient’s home to a central server, using a dedicated web-based software package. Methods Adults scheduled for elective outpatient surgery were prospectively enrolled. In the first 5 postoperative days, patients completed a self-report questionnaire (pain, comfort, nausea, vomiting) and recorded SpO2, HR and MAP via two wireless Bluetooth monitors connected to a 4G tablet to transmit the data to a website, in real time, using Smart Angel™ software. Before transmission to the website, these data were also self-reported by the patient on a paper form. The primary outcome was the proportion of variables (self-monitored physiological data + questionnaire scores) correctly transmitted to the hospital via the system compared with the paper version. On Day 5, a system usability scale survey (SUS score 1–100) was also attributed. Results From May 2018 to September 2018, data were available for 29 out of 30 patients enrolled (1 patient was not discharged from hospital after surgery). The remote monitoring technology recorded 2038 data items (62%) compared with 2656 (82%) items recorded on the paper form (p = 0.001). The most common errors with the remote technology were software malfunctioning when starting the MAP monitor and malfunctioning between the tablet and the Bluetooth monitor. No serious adverse events were noted. The SUS score for the system was 85 (68–93) for 26 patients. Conclusion This work evaluates the ability of a pilot system for monitoring remote physiological data using digital technology after ambulatory surgery and highlights the digital limitations of this technology. Technological improvements are required to reduce malfunctioning (4G access, transmission between apps). Trial registration ClinicalTrials.gov ( NCT03464721 ) (March 8, 2018).

Published
2020
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2. Methotrexate–Etoposide–Ifosfamide Compared with Doxorubicin–Cisplatin–Ifosfamide Chemotherapy in Osteosarcoma Treatment, Patients Aged 18–25 Years

Author

Nadège Corradini, Claude Linassier, Valérie Laurence, Laurence Brugières, Isabelle Ray-Coquard, Corinne Delcambre, Nathalie Gaspar, Cyril Lervat, Marie-Cécile Le Deley, Esma Saada-Bouzid, Loic Chaigneau, Cécile Guillemet, Pierre Kerbrat, Sophie Piperno-Neumann, Perrine Marec-Berard, Olivier Collard, François Gouin, Didier Cupissol, Bob-Valéry Occean, and Marta Jimenez

Subjects
Adult, Male, Oncology, Cisplatin/Ifosfamide, medicine.medical_specialty, Adolescent, medicine.medical_treatment, Young Adult, 03 medical and health sciences, 0302 clinical medicine, Internal medicine, Antineoplastic Combined Chemotherapy Protocols, medicine, Humans, Doxorubicin, Ifosfamide, 030212 general & internal medicine, Etoposide, Etoposide/ifosfamide, Osteosarcoma, Chemotherapy, business.industry, medicine.disease, Clinical trial, Methotrexate, 030220 oncology & carcinogenesis, Pediatrics, Perinatology and Child Health, Toxicity, Female, Cisplatin, business, medicine.drug
Abstract

Purpose: The French standard chemotherapy for osteosarcoma combines high-dose methotrexate (HDM) and etoposide–ifosfamide (EI) in children and adolescents, and API-AI (doxorubicin–cisplatin–ifosfam...

Published
2020
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3. Results of methotrexate-etoposide-ifosfamide based regimen (M-EI) in osteosarcoma patients included in the French OS2006/sarcome-09 study

Author

Cécile Verite-Goulard, Nadir Cheurfa, Laurence Brugières, Sophie Piperno-Neumann, Laure Saumet, Nathalie Gaspar, Nadège Corradini, Perrine Marec-Berard, Hervé Brisse, Marie-Cécile Le Deley, Françoise Rédini, Claudine Schmitt, Gsf-Geto (Groupe Sarcome Français), Jessy Delaye, Hélène Pacquement, Emmanuelle Bompas, Marie-Pierre Castex, Jean-Claude Gentet, Bob-Valéry Occean, Natacha Entz-Werle, Cyril Lervat, Eric Mascard, Marie-Dominique Tabone, Corine Bouvier, Sfce, Antoine Italiano, Département de cancérologie de l'enfant et de l'adolescent [Gustave Roussy], Institut Gustave Roussy (IGR), Service de biostatistique et d'épidémiologie (SBE), Direction de la recherche clinique [Gustave Roussy], Institut Gustave Roussy (IGR)-Institut Gustave Roussy (IGR), Département d'oncologie pédiatrique [Institut Curie, Paris], Institut Curie [Paris], Département d'oncologie médicale [Saint Herblain], Institut de Cancérologie de l'Ouest [Angers/Nantes] (UNICANCER/ICO), UNICANCER-UNICANCER, Département de pathologie [CHU La Timone, Marseille], Hôpital de la Timone [CHU - APHM] (TIMONE), Service de l'Imagerie [Institut Curie, Paris], Paris-Sciences-et-Lettres Research University [Paris], Département d'oncologie pédiatrique [CHU Toulouse], CHU Toulouse [Toulouse], Département d'Oncologie Pédiatrique [CHU Nantes], Hôpital Mère-Enfant, CHU de Nantes, UNICANCER [Paris], Fédération nationale des Centres de lutte contre le Cancer (FNCLCC), Département d'Oncologie Pédiatrique [CHU Hautepierre, Strasbourg], Hôpital de Hautepierre [Strasbourg], Pédiatrie et oncologie pédiatrique [Hôpital de la Timone - APHM], Aix Marseille Université (AMU)-Assistance Publique - Hôpitaux de Marseille (APHM)- Hôpital de la Timone [CHU - APHM] (TIMONE), Département d'oncologie médicale, Institut Bergonié [Bordeaux], Unité d'oncologie pédiatrique [Centre Oscar Lambret, Lille], Centre Régional de Lutte contre le Cancer Oscar Lambret [Lille] (UNICANCER/Lille), Université Lille Nord de France (COMUE)-UNICANCER-Université Lille Nord de France (COMUE)-UNICANCER, Département d'oncologie pédiatrique [Centre Léon Bérard, Lyon], Centre Léon Bérard [Lyon], Service de chirurgie orthopédique et traumatologie pédiatrique [CHU Necker ], CHU Necker - Enfants Malades [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Physiopathologie des Adaptations Nutritionnelles (PhAN), Université de Nantes - UFR de Médecine et des Techniques Médicales (UFR MEDECINE), Université de Nantes (UN)-Université de Nantes (UN)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE), Département d'oncologie pédiatrique [Hôpital A. de Villeneuve, Montpellier], Hôpital Arnaud de Villeneuve [CHRU Montpellier], Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier)-Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Service d'Hématologie et d'Oncologie Pédiatrique [CHRU Nancy], Centre Hospitalier Régional Universitaire de Nancy (CHRU Nancy), CHU Trousseau [APHP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Département d'oncologie pédiatrique [CHU Bordeaux], Hôpital des Enfants - Groupe hospitalier Pellegrin - CHU de Bordeaux, Centre de recherche en épidémiologie et santé des populations (CESP), Université de Versailles Saint-Quentin-en-Yvelines (UVSQ)-Université Paris-Sud - Paris 11 (UP11)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Paul Brousse-Institut National de la Santé et de la Recherche Médicale (INSERM), Université Lille Nord de France (COMUE)-UNICANCER, Département d'Oncologie Médicale [Institut Curie, Paris], French National Cancer Institute (INCa) (INCA RC004 and PHRC-K13-041), NOVARTIS, Chugai, Ligue Nationale contre le Cancer, Fédération Enfants et Santé, Société Française des Cancers et Leucémies de l’Enfant., the SFCE (Société Française des Cancers de l’Enfant et l’adolescent), GSF-GETO (Groupe Sarcome Français), the UNICANCER sarcoma group., Sercice Hématologie, immunologie et oncologie pédiatrique [CHU Toulouse], Pôle Enfants [CHU Toulouse], Centre Hospitalier Universitaire de Toulouse (CHU Toulouse)-Centre Hospitalier Universitaire de Toulouse (CHU Toulouse), Université de Lille-UNICANCER-Université de Lille-UNICANCER, Institut National de la Recherche Agronomique (INRA)-Université de Nantes (UN), Université de Lille-UNICANCER, and maurice, sandrine

Subjects
Male, 0301 basic medicine, Cancer Research, medicine.medical_treatment, Kaplan-Meier Estimate, Zoledronic Acid, 0302 clinical medicine, Antineoplastic Combined Chemotherapy Protocols, Medicine, Young adult, Child, Etoposide, [SDV.MHEP.RSOA] Life Sciences [q-bio]/Human health and pathology/Rhumatology and musculoskeletal system, Osteosarcoma, Ifosfamide, Diphosphonates, Imidazoles, Combined Modality Therapy, 3. Good health, Oncology, [SDV.MHEP.RSOA]Life Sciences [q-bio]/Human health and pathology/Rhumatology and musculoskeletal system, Child, Preschool, 030220 oncology & carcinogenesis, Female, France, medicine.drug, Adult, medicine.medical_specialty, Neutropenia, Adolescent, Bone Neoplasms, [SDV.CAN]Life Sciences [q-bio]/Cancer, Young Adult, 03 medical and health sciences, [SDV.MHEP.PED] Life Sciences [q-bio]/Human health and pathology/Pediatrics, [SDV.CAN] Life Sciences [q-bio]/Cancer, Humans, Chemotherapy, [SDV.MHEP.PED]Life Sciences [q-bio]/Human health and pathology/Pediatrics, business.industry, medicine.disease, Surgery, Regimen, 030104 developmental biology, Methotrexate, Doxorubicin, Cisplatin, business
Abstract

Background In most countries, reference chemotherapy for osteosarcoma is MAP regimen (M = high-dose methotrexate, AP = doxorubicin-cisplatinum). In France, the standard preoperative chemotherapy for children/adolescents combines M and etoposide-ifosfamide (EI), based on the OS94-trial. We report the safety and efficacy results of patients ≤25 years treated with preoperative M-EI regimen enroled in the French OS2006-study, between 2007 and 2014. Methods Treatment comprised preoperative chemotherapy with the 7 M-courses and 2 EI-courses, then surgery and postoperative chemotherapy assigned by risk's groups: standard-risk (good histological response without metastases) received 12 M-courses, 3 EI-courses; high-risk (poor histologic response, initial metastases or unresectable primary) received 5 M-courses alternated with 5 AP-courses. 253 patients were randomised to receive (n = 128) or not (n = 125) zoledronate. Results 409/522 patients enroled in the OS2006 study who received preoperative M-EI were analysed. Median age was 14.3 years (4.7–24.5), with 55 patients aged 18–25 years. Primary tumour location was limb in 383 patients (94%) and 85 (21%) presented metastases. Median chemotherapy duration was 37.4 weeks. 381 (96%) patients underwent surgery, 258 patients (65%) had a good histologic response. 187/324 patients (58%) with localised disease did not receive doxorubicin nor cisplatinum. Toxicity was evaluated in the randomised study: most patients experienced ≥1 severe toxicity (grade IV haematological or grade III/IV extra-haematological). Median follow-up was 4.8 years, and 168 patients had events. Five-year event-free survival was 56% (95% CI, 51–62%) and overall survival 71% (66–76%). Conclusion M-EI regimen/strategy was feasible for patient aged ≤25 years with survival rates are comparable to those obtained with MAP regimen.

Published
2017
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4. Ultrasound guidance in difficult radial artery puncture for blood gas analysis: A prospective, randomized controlled trial.

Author

Romain Genre Grandpierre, Xavier Bobbia, Laurent Muller, Thibaut Markarian, Bob-Valéry Occéan, Stéphane Pommet, Claire Roger, Jean Yves Lefrant, Jean Emmanuel de la Coussaye, and Pierre-Géraud Claret

Subjects
Medicine, Science
Abstract

BackgroundUltrasound (US) guidance has yet to prove its applicability in radial arterial blood gas analysis (ABGA) punctures. The main objective of our study was to compare the number of first-attempt successes (NFAS) for radial arterial puncture in difficult patients with or without US guidance. The Secondary aims were to compare the number of punctures (NOP), puncture time, and patient pain.MethodsIn this single-center, randomized controlled trial, patients who required a radial ABGA and in whom the arterial puncture was assessed as difficult (because of non-palpable radial arteries or two previous puncture failures by a nurse) were assigned to the US group or no-US (NUS) group (procedure performed by a trained physician).ResultsThirty-six patients were included in the US group and 37 in the NUS groups. The NFAS was 7 (19%) in the NUS group and 19 (53%) in the US group. The relative risk of success in the US group was 2.79 (95% CI,1.34 to 5.82), p = 0.01. In the NUS and US groups, respectively, the median NOP was 3 [2; 6] vs. 1 [1; 2], estimated difference -2.0 (95%CI, -3.4 to -0.6), p < 0.01; the respective puncture time was 3.1 [1.6; 5.4] vs. 1.4 [0.6; 3.1] min, estimated difference -1.45 (95%CI, -2.57 to -0.39), p = 0.01; the respective median patient pain was 6 [4; 8] vs. 2 [1; 4], estimated difference -4.0 (95%CI, -5.8 to -2.3); p < 0.01.ConclusionUS guidance by a trained physician significantly improves the rate of success in difficult radial ABGA patients.

Published
2019
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