Study on the Effect of Rocuronium Bromide, Sugammadex, and Suxamethonium Chloride for Adults with Respiratory Distress Requiring Emergency Tracheal Intubation

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What is this study about?

This clinical trial is focused on improving the process of emergency tracheal intubation, which is a procedure used to help patients breathe when they are experiencing severe breathing problems, known as respiratory distress. The study will use a combination of medications and techniques to see if they can reduce complications that might occur after the procedure. The medications involved in this study include Rocuronium, Sugammadex, and Suxamethonium. These are used to help relax the muscles during intubation, making the process smoother and potentially safer.

The purpose of the study is to evaluate whether this new strategy can decrease the number of complications that happen shortly after intubation. Participants in the study will receive either the new combination of treatments or the usual care. The study will observe the effects of these treatments on patients who need emergency intubation outside of a hospital setting. The trial will monitor the patients for any severe complications, such as low blood pressure, low oxygen levels, or other issues that might arise during the first hour after intubation.

Throughout the study, researchers will also look at how difficult the intubation process is, how long it takes to provide care outside the hospital, and the amount of medication needed after intubation. The study will follow patients until they are admitted to the hospital and will check their health status up to 28 days later. This research aims to find better ways to perform emergency intubations and improve patient outcomes.

1 joining the study

Upon meeting the inclusion criteria, participation in the study begins. The criteria include being an adult patient (18 years or older) experiencing vital distress and requiring emergency endotracheal intubation, excluding those in cardiac arrest.

2 administration of medications

The study involves the use of three medications administered intravenously. These are rocuronium bromide, sugammadex, and suxamethonium chloride. The specific dosages and frequency of administration are determined by the medical team based on individual patient needs.

3 intubation process

The intubation process is optimized using a strategy that includes rocuronium, bag face-mask ventilation before intubation, and the use of a gum elastic bougie (GEB) as an aid. This strategy aims to reduce complications related to intubation.

4 monitoring for complications

During the first hour after intubation, monitoring occurs for severe complications. These include cardiac arrest, low blood pressure, low oxygen levels, severe heart rhythm issues, pulmonary aspiration, incorrect tube placement, and unintentional removal of the tube.

5 assessment of intubation difficulty

The difficulty of the intubation process is assessed using various scores and techniques. This includes the Intubation Difficulty Score and the Copenhagen score, as well as the use of alternative intubation techniques if necessary.

6 out-of-hospital care

The duration and quality of out-of-hospital care are evaluated. This includes the time from the arrival of emergency services to hospitalization, the amount of sedative and vasopressor drugs used, and the mortality rate during this period.

7 follow-up and mortality assessment

The follow-up period extends to 28 days post-intubation. Mortality is assessed using the French Register of deceased persons to determine the vital status of patients after hospital admission.

Who Can Join the Study?

The patient must be an adult, which means they are 18 years old or older.
The patient must be experiencing vital distress, which is a serious condition where the body is struggling to function properly, and they need an emergency procedure called endotracheal intubation. This is when a tube is placed into the windpipe to help with breathing.
The patient must be treated by the participating SMUR, which is a medical emergency service.
The patient can have any condition like trauma (injury), dyspnea (difficulty breathing), coma (unconsciousness), overdoses, or shock, but they should not be in cardiac arrest, which is when the heart stops beating.
Both male and female patients can participate.
The study does not include vulnerable populations, which means groups of people who might need special protection or care.

Who Cannot Join the Study?

Patients who are not adults. This means anyone under the age of 18 cannot participate.
Patients who are part of a vulnerable population. This refers to groups of people who might need special protection or care, such as those with certain disabilities or conditions.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Groupe Hospitalier Du Sud Ile De France	Melun	France
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France
Oncopole Claudius Regaud	Toulouse	France
CHU Grenoble Alpes	La Tronche	France

Other Sites

Site Name	City	Country
Centre Hospitalier Universitaire De La Reunion	St Denis	France
Centre Hospitalier Universitaire De Poitiers	Poitiers	France
Centre Hospitalier Universitaire De Montpellier	Montpellier	France
Centre Hospitalier Universitaire De Nantes	Nantes	France
Hopital NOVO	Pontoise	France
Centre Hospitalier Lyon Sud	Pierre Benite	France
Hopital Beaujon	Clichy	France
Gpowjivahx Hepkpvxwdqj Euuhfevu Mtkztbgkvtm Sjipsa Vgmt	Eaubonne	France
Cwtxnd Hoaathmhdrg Rizrhdfa Ddvuomsctnpsvn	Angers	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	14.01.2023

Trial locations

Investigated drugs:

Rocuronium is a medication used to relax the muscles during surgery or other medical procedures. In this trial, it is used to help with tracheal intubation, which is the process of inserting a tube into the windpipe to help a patient breathe. Rocuronium helps by relaxing the muscles around the windpipe, making it easier to insert the tube.

Bag Face-Mask Ventilation is a technique used to help patients breathe before intubation. It involves using a mask that fits over the patient’s nose and mouth, connected to a bag that can be squeezed to push air into the lungs. This helps ensure the patient gets enough oxygen before the intubation procedure.

GEB (Gum Elastic Bougie) is a flexible tool used to assist with tracheal intubation. It is inserted into the windpipe to guide the placement of the intubation tube. The GEB helps ensure that the tube is correctly positioned, which is important for the patient’s safety and effective breathing support.

Investigated diseases:

Respiratory distress

Respiratory Distress – Respiratory distress is a condition where an individual experiences difficulty in breathing, often characterized by rapid, shallow breathing and a feeling of not getting enough air. It can occur due to various reasons, including lung infections, asthma, or chronic obstructive pulmonary disease (COPD). The condition may lead to increased heart rate, sweating, and a bluish tint to the skin due to lack of oxygen. As it progresses, the person may struggle more to breathe, and the chest may move inwards with each breath. In severe cases, respiratory distress can lead to exhaustion and confusion due to insufficient oxygen reaching the brain. It requires immediate medical attention to prevent further complications.

Trial ID:

2024-514913-37-00

Protocol code:

CHUBX 2021/25

NCT ID:

NCT05539391

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study on the Effect of Rocuronium Bromide, Sugammadex, and Suxamethonium Chloride for Adults with Respiratory Distress Requiring Emergency Tracheal Intubation

What is this study about?

Who Can Join the Study?

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