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Respiratory Insufficiency clinical trials

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NCT ID: NCT06408714 Not yet recruiting - Opioid Overdose Clinical Trials

Nalmefene vs Naloxone for the Treatment of Recurrent Respiratory Depression After Opioid Overdose

Start date: July 1, 2024
Phase: Phase 3
Study type: Interventional

The goal of this clinical trial is to compare naloxone to nalmefene for the treatment of opioid overdose in adults. The main questions it aims to answer are: - Does nalmefene lower the number of doses of medicine participants need to treat opioid overdose? - When participants are given nalmefene instead of naloxone, do they have fewer complications of opioid overdose such as being admitted to the hospital or having a breathing tube inserted? Researchers will compare nalmefene to naloxone for the treatment of opioid overdose. Nalmefene and naloxone are both approved medicines to treat opioid overdose. Participants who are brought to the emergency department after an opioid overdose will be given a dose of either nalmefene or naloxone if their breathing slows down again after an opioid overdose. Participants will: - Stay in the emergency department for 8 hours after receiving a dose of nalmefene or naloxone. - Receive a phone call 7 days after their emergency department to check on how they are doing. Background information: Naloxone (also known as Narcan) and nalmefene are opioid blocking medicines. When someone overdoses on an opioid, such as heroin or fentanyl, their breathing slows down or stops and they can die. By giving naloxone or nalmefene, the effect of the opioid can be blocked and the person can start breathing again. Naloxone is the most commonly used medicine to reverse an opioid overdose. The effect of naloxone lasts about an hour, and patients may need more than one dose of naloxone to keep them breathing. Sometimes patients overdose, get a dose of naloxone and wake up, and then some time later their breathing slows down again and they need another dose of naloxone. This can happen because the effect of the opioid they took lasts longer than the effect of the naloxone. The effect of nalmefene lasts longer than naloxone, about four hours. If a person gets nalmefene, their opioid may wear off before the nalmefene wears off and they might not need any more doses of a reversal medicine. Both naloxone and nalmefene are approved medicines for treating opioid overdose. Often, when a person overdoses on an opioid, someone gives them naloxone right away and then they are brought to the emergency department. In the emergency department, they are watched for several hours to make sure they don't stop breathing again when their naloxone wears off. If they do stop breathing again, they are given another dose of naloxone. In this study, participants will be given either nalmefene or naloxone if their breathing slows down while they are in the emergency department.

NCT ID: NCT06401239 Not yet recruiting - Mental Health Issue Clinical Trials

Investigating Dyadic Expectations About ARF Survivorship (IDEAS)

IDEAS
Start date: July 2024
Phase:
Study type: Observational

The purpose of this observational study is to understand how adults who survive acute respiratory failure (ARF) and the people (usually family) who support ARF survivors after returning home think about the first 6 months of recovery. The study aims to find out if expectations about the recovery process after ARF are associated with mental health symptoms in both survivors and the survivor's care partners. Study participants will complete 3 surveys over 6 months. These surveys ask questions about participants' future expectations, feelings, and mood. Surveys can be completed online, over the phone, or on paper.

NCT ID: NCT06395532 Not yet recruiting - Respiratory Failure Clinical Trials

Integrated Pulmonary Index as a Predictor of Respiratory Compromise in Critically Ill Patients

Start date: May 15, 2024
Phase:
Study type: Observational

The integrated pulmonary index (IPI) is a newly developed index for respiratory monitoring. However, there is limited evidence on its effectiveness and usefulness in critically ill patients. The purpose of this study is to evaluate the clinical relevance of the IPI as a predictor of respiratory compromise in critically ill patients.

NCT ID: NCT06367686 Not yet recruiting - Clinical trials for Pulmonary Disease, Chronic Obstructive

Detecting Systemic Carbon Dioxide Levels With a Novel Biosensor

DISCO
Start date: May 2024
Phase:
Study type: Observational

The study is an open, prospective, single center clinical observational pilot investigation. The aim is to compare the carbon dioxide values measured by the IscAlert sensor, which is inserted in proximity to the nasal mucosa. The study wants to investigate if the nasal mucosa application and measurements are feasible, what kind of possible complications such a measurement can cause, and if the measurements can be a surrogate marker for systemic carbon dioxide values.

NCT ID: NCT06364280 Not yet recruiting - Critical Illness Clinical Trials

Pediatric Prehospital Airway Resuscitation Trial

Pedi-PART
Start date: May 1, 2024
Phase: N/A
Study type: Interventional

This study is a Phase 3, multi-center, Bayesian Adaptive Sequential Platform Trial testing the effectiveness of different prehospital airway management strategies in the care of critically ill children. Emergency Medical Services (EMS) agencies affiliated with the Pediatric Emergency Care Applied Research Network (PECARN) will participate in the trial. The study interventions are strategies of prehospital airway management: [BVM-only], [BVM followed by SGA] and [BVM followed by ETI]. The primary outcome is 30-day ICU-free survival. The trial will be organized and executed in two successive stages. In Stage I of the trial, EMS personnel will alternate between two strategies: [BVM-only] or [BVM followed by SGA]. The [winner of Stage I] will advance to Stage II based upon results of Bayesian interim analyses. In Stage II of the trial, EMS personnel will alternate between [BVM followed by ETI] vs. [Winner of Stage I].

NCT ID: NCT06357780 Not yet recruiting - Clinical trials for Acute Respiratory Distress Syndrome

Closed-loop syncHronization vErsuS convenTional Synchronization in sPontaneously Breathing Adult Nonivasive ventilationPatients

CHESTSPAN
Start date: April 8, 2024
Phase: N/A
Study type: Interventional

The study is a multicentric prospective randomised cross-over study. It evaluates the compatibility of patients with the device without altering the routine treatment applied. During this evaluation, either the clinician-adjusted values on the device or the standard pre-set values are used to obtain hourly and 30-minute PVA (Patient Ventilator Asynchrony) recordings. These recordings will be analysed offline to identify the settings used and to compare the hourly and 30-minute PVA (Patient Ventilator Asynchrony) values when synchronisation is automatically set. The relationships and differences between these values will be analysed. For this purpose, the IntelliSync+ option, already available on the device, will be used. This software continuously analyses waveform signals at least a hundred times per second. This allows for the immediate detection of patient efforts and the initiation of inspiration and expiration in real time, thereby replacing traditional trigger settings for inspiration and expiration. If the patient is already synchronised with this option, it will then be possible to switch to traditional synchronisation settings for comparison. Statistical analyses will be conducted using SPSS 24.0, JASP (Just Another Statistical Programme), Jamovi ( fork of JASP), or R software. Initially, all numerical and categorical data will be evaluated using descriptive statistical methods. The distributions of numerical variables will be examined using visual (histograms and probability plots) and analytical methods (Kolmogorov-Smirnov/Shapiro-Wilk tests). Mean/SD (standard deviation) or median/interquartile range (IQR) will be used as measures of distribution. For comparing numerical data that follows a normal distribution, the Student-t test will be used, and for non-normally distributed data, the Mann-Whitney U or Wilcoxon signed-rank tests will be employed. PVA (Patient Ventilator Asynchrony) values will be statistically compared. For the analysis of categorical data, the Chi-Square test will be applied. Bayesian analysis may also be used as necessary during the writing of the study. The results obtained will be interpreted and reported by the researchers. Results with a "p" value below 0.05 will be considered statistically significant.

NCT ID: NCT06343545 Not yet recruiting - Clinical trials for Acute Respiratory Failure

Evaluation of the Impact of Rehabilitation Strategies and Early Discharge After Respiratory Failure

Rehab
Start date: April 1, 2024
Phase: N/A
Study type: Interventional

To evaluate, through a randomized clinical trial in groups/clusters (stepped wedge), the impact of specific bundles for disability prevention and early rehabilitation, focused on 3 domains (ICU, Ward and post-discharge), on health-related quality of life and other long- and short-term outcomes in critically ill patients affected by hypoxemic acute respiratory failure with suspected COVID-19.

NCT ID: NCT06341972 Not yet recruiting - Anxiety Clinical Trials

Improving Psychological Outcomes for Acute Respiratory Failure Survivors Using a Self-Management Intervention

SMARA
Start date: June 15, 2024
Phase: N/A
Study type: Interventional

A growing number of patients are surviving a stay in the intensive care unit (ICU) but may experience long-lasting psychological problems, but research evaluating such treatment for ICU patients is scant. The goal of this pilot randomized controlled trial is to evaluate the feasibility, acceptability, and potential benefit of an evidence-based psychological intervention for anxiety and associated outcomes for ICU patients. The main question[s] it aims to answer are: - Is this intervention feasible and acceptable in ARF patients? - Is this intervention in the ICU and hospital associated with reduced anxiety symptoms? Participants will participate in a cognitive behavioral therapy informed self-management intervention aimed to reduce anxiety symptoms. Researchers will compare the intervention group to patients who receive usual care to see if the intervention reduces symptoms at the the conclusion of the intervention and at 3 months follow-up.

NCT ID: NCT06336265 Not yet recruiting - Clinical trials for Hypoxic Respiratory Failure

Diaphragmatic Ultrasound to Predict the Therapeutic Effect of High-flow Nasal Cannula Oxygen Therapy

Start date: April 1, 2024
Phase:
Study type: Observational

Follow-up was conducted for every patient requiring high-flow nasal cannula oxygen therapy in district 1 of the Intensive Care Department of Chenzhou NO.1 People's Hospital. Patients who met the inclusion criteria but did not meet the exclusion criteria were included for observation. Respiratory parameters, diaphragmatic activity, and variation rate of diaphragmatic thickness were recorded at the beginning of high-flow nasal cannula oxygen therapy, 1 hour after treatment, 3 hours after treatment, 6 hours after treatment, 9 hours after treatment, and 12 hours after treatment. Throughout the procedure, a panel of experts assessed whether the patient needed endotracheal intubation; If yes, the study was terminated; if no, high-flow nasal cannula oxygen therapy was continued, and observation and evaluation were continued until the end point of the study (12 hours after treatment). If patients or their family members do not want to continue to participate in the study during the study, they will be considered as withdrawal. If patients suffer from sudden malignant arrhythmia or cardiac arrest during the study, resulting in death or transfer to other hospitals or other departments during the study, patients will be excluded. Data from dropped and excluded patients were not included in the final statistical analysis. After the data of 269 patients were collected, the study was concluded, and the results and conclusions were derived by statistical analysis.

NCT ID: NCT06308926 Not yet recruiting - Clinical trials for Acute Respiratory Distress Syndrome

MRG-001 as an Immunoregulatory and Regenerative Therapy for ARDS Patients

SUMMIT
Start date: July 1, 2024
Phase: Phase 2
Study type: Interventional

This is a phase IIa, dose-ranging, proof-of-concept study of MRG-001 in patients with ARDS. The aim is to determine the safety and preliminary efficacy of MRG-001 across two dose ranges.