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Phase II study comparing nasal pressure monitoring with capnography during invasive endoscopic procedures: a single-center, single-arm trial.

ABSTRACT: Nasal pressure signal is commonly used to evaluate obstructive sleep apnea. This study aimed to assess its safety for respiratory monitoring during sedation. A total of 45 adult patients undergoing sedation with propofol and fentanyl for invasive endoscopic procedures were enrolled. While both nasal pressure and capnograph signals were continuously recorded, only the nasal pressure signal was displayed. The primary outcome was the incidence of oxygen desaturation below 90%. The secondary outcomes were the ability to predict the desaturation and incidence of harmful events and false alarms, defined as an apnea waveform lasting more than 3 min without desaturation. Of the 45 participants, 43 completed the study. At least one desaturation event occurred in 12 patients (27.9%; 95% confidence interval 15.3-43.7%). In these 12 patients, more than half of the desaturation events were predictable in 9 patients by capnography and 11 patients by nasal pressure monitoring (p = 0.59). In the 43 patients, false alarms were detected in 7 patients with capnography and 11 patients with nasal pressure monitoring (p = 0.427). Harmful events unrelated to nasal pressure monitoring occurred in 2 patients. Nasal pressure monitoring is safe and possibly useful for respiratory monitoring despite false alarms during sedation.

SUBMITTER: Nagashima H

PROVIDER: S-EPMC9871023 | biostudies-literature | 2023 Jan

REPOSITORIES: biostudies-literature

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Phase II study comparing nasal pressure monitoring with capnography during invasive endoscopic procedures: a single-center, single-arm trial.

Nagashima Hiroki H Mikata Rintaro R Isono Shiroh S Ogasawara Sadahisa S Sugiyama Harutoshi H Ohno Izumi I Yasui Shin S Matsumura Tomoaki T Koroki Keisuke K Kusakabe Yuko Y Miura Yoshifumi Y Kan Motoyasu M Maruta Shikiko S Yamada Toshihito T Takemura Ryo R Sato Yasunori Y Kato Jun J Kato Naoya N

Scientific reports 20230123 1

Nasal pressure signal is commonly used to evaluate obstructive sleep apnea. This study aimed to assess its safety for respiratory monitoring during sedation. A total of 45 adult patients undergoing sedation with propofol and fentanyl for invasive endoscopic procedures were enrolled. While both nasal pressure and capnograph signals were continuously recorded, only the nasal pressure signal was displayed. The primary outcome was the incidence of oxygen desaturation below 90%. The secondary outcome ...[more]

PMID: 36690708

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Project description:BackgroundEvidence to date suggests that capnography monitoring during gastrointestinal endoscopic procedures (GEP) reduces the incidence of hypoxemia, but the association of capnography monitoring with the incidence of other adverse outcomes surrounding these procedures has not been well studied. Our aims were to estimate the incidence of pharmacological rescue events and death at discharge from an inpatient or outpatient hospitalization where GEP was performed with sedation, and to determine if capnography monitoring was associated with reduced incidence of these adverse outcomes.MethodsThis retrospective Premier Database analysis included medical inpatients and all outpatients undergoing GEP with sedation. Patients were grouped as follows: (1) pulse oximetry (SpO2) only, (2) capnography only, (3) SpO2 with capnography, and (4) neither SpO2 nor capnography. Multivariable logistic regression and propensity-score matching were used to compare patients with capnography sensor use to patients with only SpO2 sensor use. Outcome measures included the incidence of pharmacological rescue events, as defined by administration of naloxone and/or flumazenil, and death.ResultsTwo hundred fifty eight thousand and two hundred sixty two inpatients and 3,807,151 outpatients were analyzed. For inpatients, capnography monitoring was associated with a 47% estimated reduction in the odds of death at discharge (OR: 0.53 [95% CI: 0.40-0.70]; P < 0.0001) and a non-significant 10% estimated reduction in the odds of pharmacological rescue event at discharge (0.91 [0.65-1.3]; P = 0.5661). For outpatients, capnography monitoring was associated with a 61% estimated reduction in the odds of pharmacological rescue event at discharge (0.39 [0.29, 0.52]; P < 0.0001) and a non-significant 82% estimated reduction in the odds of death at discharge (0.18 [0.02, 1.99]; P = 0.16).ConclusionsIn hospital medical inpatients and all outpatients undergoing GEP performed with sedation, capnography monitoring was associated with a reduced likelihood of pharmacological rescue events in outpatients and death in inpatients when assessed at discharge. Despite the limitations of the retrospective data analysis methodology, the use of capnography during these procedures is recommended.

Project description:BackgroundNonoperating room anesthesia during gastroenterological procedures is a growing field in anesthetic practice. While the numbers of patients with severe comorbidities are rising constantly, gastrointestinal endoscopic interventions are moving closer to minimally invasive endoscopic surgery. The LMA Gastro™ is a new supraglottic airway device, developed specifically for upper gastrointestinal endoscopy and interventions. The aim of this study was to evaluate the feasibility of LMA Gastro™ in patients with ASA physical status ≥3 undergoing advanced endoscopic procedures.MethodsWe analyzed data from 214 patients retrospectively who received anesthesia for gastroenterological interventions. Inclusion criteria were upper gastrointestinal endoscopic interventions, airway management with LMA Gastro™ and ASA status ≥3. The primary outcome measure was successful use of LMA Gastro™ for airway management and endoscopic intervention.ResultsThirtyone patients with ASA physical status ≥3, undergoing complex and prolonged upper gastrointestinal endoscopic procedures were included. There were 7 endoscopic retrograde cholangiopancreatographies, 7 peroral endoscopic myotomies, 5 percutaneous endoscopic gastrostomies and 12 other complex procedures (e.g. endoscopic submucosal dissection, esophageal stent placement etc.). Of these, 27 patients were managed successfully using the LMA Gastro™. Placement of the LMA Gastro™ was reported as easy. Positive pressure ventilation was performed without difficulty. The feasibility of the LMA Gastro™ for endoscopic intervention was rated excellent by the endoscopists. In four patients, placement or ventilation with LMA Gastro™ was not possible.ConclusionsWe demonstrated the feasibility of the LMA Gastro™ during general anesthesia for advanced endoscopic procedures in high-risk patients.Trial registrationGerman Clinical Trials Register (DRKS00017396) Date of registration: 23rd May 2019, retrospectively registered.

Project description:Extranodal NK/T-cell lymphoma, nasal type (ENKTL), which is a rare form of mature T/NK cell lymphoma in children, currently lacks a standardized first-line treatment approach. However, a treatment protocol known as the "sandwich" regimen has been used in children newly diagnosed with ENKTL. This protocol combines the administration of methotrexate, ifosfamide, etoposide, pegaspargase, and dexamethasone (referred to as SMILE) with the addition of radiotherapy (RT). From September 2017 to December 2020, a total of five patients were included in the study, consisting of three males and two females. The median age of onset was 10.6 years (range, 9.8 to 14.0 years). Among the patients, four had nasal/nasopharyngeal disease at stage II, while one patient had extra nasal disease involving the skin at stage IV. The median EBV-DNA level in plasma was 1.68 × 103 copies/ml (range, 0.44 to 21.1 × 103copies/ml). All the patients had good overall response after 2 cycles of chemotherapy and radiotherapy, including 4 of the patients who had a complete response and 1 of the patients with partial remission. The patient with stage IV received allogeneic hematopoietic stem cell transplantation after the EBV-DNA level was elevated again during treatment. One patient in the low-risk group experienced grade 4 oral mucositis, while no other severe complications or treatment-related deaths were observed. The median follow-up period was 22 months (range, 5 to 57 months). All five patients successfully completed their treatment, with four patients achieving event-free survival, and one patient was lost to follow-up. The median OS time and EFS time was 33 months (range: 18-57 months) and 20 months (range: 5-47 months), respectively. The sandwich protocol has demonstrated a high response rate, good tolerance to chemotherapy, and no treatment-related fatalities. However, further confirmation is necessary through additional clinical studies involving larger sample sizes. Clinical trial registration number: Due to modified SMILE regimens with sandwiched radiotherapy yielded promising outcomes in children ENKTL, we have carried out a phase II multicenter clinical trial (ChiCTR220005954) for children ENKTL in China to further verify the efficacy and safety.

Project description:IntroductionFrequent self-monitoring of blood glucose (SMBG) is usually required in patients with type 1 diabetes (T1D). However, the fear of self-testing, hygiene, and social obstacles may deter some patients from SMBG. Flash glucose monitoring (FGM), a less-invasive glucose monitoring method, was launched in Japan in September 2017. The aim of this study was to evaluate patient satisfaction and the clinical efficacy of FGM in Japanese patients with T1D.MethodsPatient satisfaction with FGM was assessed using the Diabetes Treatment Satisfaction Questionnaire (DTSQ) and Diabetes Therapy-Related Quality of Life (DTR-QOL) questionnaire before (baseline) and 4 and 12 weeks after initiating FGM use in 20 Japanese patients with T1D. Clinical parameters related to glucose metabolism, such as glycated hemoglobin (HbA1c) levels, were assessed, and glucose fluctuations were evaluated using the FGM data. Values at 4 and 12 weeks after initiating FGM were compared with baseline data using the Wilcoxon signed-rank test. The mean absolute relative difference (MARD) between glucose values detected using the FGM device and by SMBG was also calculated.ResultsThe DTSQ scores significantly improved 12 weeks after initiating FGM (P < 0.001). The DTR-QOL scores related to "burden in social activities" and "treatment satisfaction" also significantly improved 12 weeks after initiating FGM (P = 0.024 and 0.007, respectively). The HbA1c values and the percentage of time within the target glucose range (3.9-7.8 mmol/L) at the 12-week time point also improved, from 58 ± 5 (baseline) to 54 ± 4 mmol/mol (P = 0.002) and from 36% (interquartile range [IQR] 25-44.5%) (baseline) to 43% (IQR 39-50%) (P = 0.016), respectively. The MARD between glucose values detected using FGM and those detected using SMBG was 12.2% throughout the study period.ConclusionsFlash glucose monitoring contributed to improved patient satisfaction and the adjustment of blood glucose levels in patients with T1D.Trial registrationUniversity Hospital Medical Information Network Clinical Trials Registry (UMIN-CTR): UMIN000029673.

Dataset Information

Phase II study comparing nasal pressure monitoring with capnography during invasive endoscopic procedures: a single-center, single-arm trial.

Publications

Phase II study comparing nasal pressure monitoring with capnography during invasive endoscopic procedures: a single-center, single-arm trial.

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