Waveform Capnography for Acute Respiratory Failure
(WAVE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial evaluates which method better ensures correct placement of a breathing tube during emergencies. It compares two techniques for detecting carbon dioxide (CO2) levels: waveform capnography (a graph of CO2 levels) and colorimetric detection (a color change device). This is crucial for critically ill patients who require a breathing tube in the emergency room or intensive care unit. Patients undergoing emergency tracheal intubation, with a planned use of a CO2 detection device by their doctor, may be suitable for this study. As a Phase 3 trial, it represents the final step before FDA approval, offering participants a chance to contribute to a potentially life-saving advancement.
Do I need to stop my current medications for this trial?
The trial information does not specify whether you need to stop taking your current medications.
What prior data suggests that these methods are safe for identifying tracheal placement during intubation?
Previous studies have shown that color-changing carbon dioxide detectors are very reliable, confirming correct tube placement every time without false alarms. This makes them safe and accurate for checking tube placement.
Waveform capnography serves as an important tool for preventing serious problems during intubation and is considered the best method to reduce risks during these procedures. However, some patients may still experience issues like heart and blood pressure problems or very low blood oxygen during intubation. These issues relate to the intubation process itself, not the safety of waveform capnography.
Both methods are generally considered safe for checking tube placement, but they do not eliminate all risks associated with intubation.12345Why are researchers excited about this trial?
Researchers are excited about this trial because it examines the effectiveness of waveform capnography compared to traditional colorimetric carbon dioxide detection during emergency tracheal intubations. The unique aspect of waveform capnography is its ability to provide a continuous, real-time graphical representation of carbon dioxide levels, offering immediate feedback about the placement of the tracheal tube. This contrasts with colorimetric detection, which only changes color to indicate the presence of CO2 without providing ongoing data. By potentially improving accuracy and speed in critical situations, this trial could lead to enhanced patient outcomes in emergency settings.
What evidence suggests that waveform capnography and colorimetric CO2 detection are effective for identifying tracheal placement during intubation?
This trial will compare two methods for verifying breathing tube placement during emergency tracheal intubation in critically ill adults: waveform capnography and colorimetric carbon dioxide detection. Studies have shown that waveform capnography effectively ensures correct breathing tube placement during intubation, reliably indicating whether the tube is in the airway or mistakenly in the stomach. Research has demonstrated that proper use of capnography can significantly reduce deaths related to airway issues in the ICU. Colorimetric carbon dioxide detection also checks tube placement by changing color when it senses carbon dioxide, but it may not be as accurate as waveform capnography. Both methods aim to ensure correct breathing tube placement, but waveform capnography is generally considered more reliable in critical situations.13567
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Intubation Procedure
Participants undergo emergency tracheal intubation with CO2 detection methods applied
Follow-up
Participants are monitored for safety and effectiveness after the intubation procedure
What Are the Treatments Tested in This Trial?
Interventions
- Colorimetric carbon dioxide (CO2) detection
- Waveform capnography
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Adult patients who are undergoing emergency intubation in the ED and ICU
Find a Clinic Near You
Who Is Running the Clinical Trial?
Brian Driver
Lead Sponsor
Citations
Waveform Capnography Compared to Colorimetric Carbon ...
This study will compare the sensitivity and specificity of waveform capnography versus colorimetric carbon dioxide detection to identify tracheal placement of ...
Evaluation of real-time tracheal ultrasound versus ...
Misplacement of the endotracheal tube (ETT) can lead to devastating, preventable morbidity and mortality. Colorimetric carbon dioxide detectors ...
DEVICE
80% successful first attempt at intubation in DL group and 4% loss to follow up would require 2000 patients to be enrolled to detect an absolute ...
Diagnostic accuracy of end-tidal carbon dioxide detection ...
The use of colorimetric capnometry or capnography may have the potential to effectively differentiate inadvertent airway intubation from gastrointestinal ...
Waveform Capnography Compared to Colorimetric Carbon ...
This study will compare the sensitivity and specificity of waveform capnography versus colorimetric carbon dioxide detection to identify ...
Colorimetric end-tidal carbon dioxide monitoring for ...
Colorimetric ETCO2 confirmed tracheal intubations and detected esophageal intubations 100% of the time, as judged by capnography. There were no false-positive ...
Colourimetric CO2 detector compared with capnography ...
The colourimetric CO 2 detector is as accurate as IR capnography at detecting tracheal intubation, but is potentially less accurate at detecting oesophageal ...
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