Ongoing Clinical Trials for Respiratory Distress
This article presents information about 2 ongoing clinical trials investigating treatments for respiratory distress. These studies are exploring different approaches to improve breathing support and reduce complications in both adults and children experiencing severe respiratory problems.
Clinical trial locations
- France
Study on the Effect of Rocuronium Bromide, Sugammadex, and Suxamethonium Chloride for Adults with Respiratory Distress Requiring Emergency Tracheal Intubation
This trial is designed to improve the safety of emergency tracheal intubation, a life-saving procedure used when adults are experiencing severe breathing problems. The study is being conducted in France and focuses on reducing complications that can occur after inserting a breathing tube.
Main focus: The trial aims to evaluate whether a specific combination of medications and techniques can reduce the number of serious complications that occur within the first hour after emergency intubation. The study will monitor for issues such as low blood pressure, low oxygen levels, cardiac arrest, severe heart rhythm problems, pulmonary aspiration, incorrect tube placement, and unintentional removal of the tube. Researchers will also assess how difficult the intubation process is and track patient outcomes for up to 28 days after the procedure.
Investigational drugs: The trial uses three medications administered through an intravenous line. Rocuronium bromide is a muscle relaxant that helps make the intubation process smoother by relaxing the muscles around the windpipe. Sugammadex is used alongside rocuronium, and suxamethonium chloride provides additional muscle relaxation. The study also employs bag face-mask ventilation before intubation to ensure patients receive enough oxygen, and uses a flexible tool called a gum elastic bougie to guide proper tube placement.
Who can join: The trial is open to adults 18 years or older who are experiencing vital distress and require emergency endotracheal intubation outside of a hospital setting. This includes patients with conditions such as trauma, difficulty breathing, unconsciousness, overdoses, or shock. However, patients who are in cardiac arrest cannot participate. Both men and women are eligible.
Who cannot join: Anyone under 18 years of age is excluded, as are individuals from vulnerable populations who might need special protection or care.
Study on How Nitrous Oxide and Oxygen Affect Lung Health in Children with Respiratory Disorders
This trial is investigating how a medicinal gas called KALINOX 50%/50% affects the bacteria found in the lungs of children with respiratory disorders. The gas is a mixture of nitrous oxide and oxygen. The study is being conducted in France and is expected to continue until December 2026.
Main focus: The primary goal is to understand whether using this gas changes the types and variety of bacteria present in the lungs of children who need respiratory samples collected. The trial will examine the lung microbiota using advanced techniques to assess bacterial diversity. Researchers will also monitor how well children tolerate the gas, the quality of the samples collected, and any side effects that may occur. This information could help improve treatments for children with conditions like severe asthma or suspected lung infections.
Investigational drug: Nitrous oxide is a gas known for its calming and pain-relieving effects. In this trial, children inhale the gas through a mask while respiratory samples are being collected from their airways. The gas helps make the sampling process less stressful and more comfortable for the child.
Who can join: Children between 3 months and 8 years old who need respiratory sampling due to suspected lower respiratory tract infections, such as bad colds or lung infections, or who have severe asthma. The child must be unable to cough up mucus effectively on their own. At least one legal guardian must provide written consent after understanding the study details, and the child must be part of the social security system.
Who cannot join: Children who are not suspected of having a lower respiratory tract infection or who can already provide sputum samples on their own. Children with medical conditions that would make participation unsafe, those outside the specified age range, and those from vulnerable populations that cannot be safely included are also excluded.
Summary
Both ongoing clinical trials for respiratory distress are being conducted in France and address different patient populations and aspects of respiratory care. The first trial focuses on adults requiring emergency intubation in out-of-hospital settings, testing a combination of muscle relaxants and techniques to reduce complications during this critical procedure. The second trial examines pediatric patients with respiratory disorders, investigating how a nitrous oxide and oxygen mixture affects lung bacteria when collecting airway samples.
These studies reflect different approaches to improving respiratory care: one emphasizes emergency intervention safety in adults, while the other seeks to better understand lung health in children with chronic or acute respiratory conditions. Both trials aim to provide evidence that could lead to improved treatment protocols and better patient outcomes.
