Quantitative Versus qUAlitative NeuromoniToring of neUroMuscular Block for Non-cardiothoracic Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Quantitative monitoring, Qualitative monitoring.
- Who it may be relevant to
- Registry conditions: Neuromuscular Block, Residual. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Quantitative Versus qUAlitative NeuromoniToring of neUroMuscular Block for Non-cardiothoracic Surgery (The QUANTUM Trial): Single-center Cluster Randomized Multiple Crossover Trial
Overview
The purpose of this study is to assess the effect of quantitative block monitoring versus less expensive qualitative monitoring treatment effects on the lowest SpO2/FiO2 ratio in the PACU. The results will be incorporated into an enhanced recovery pathway for surgical patients.
Interventions
- Device Quantitative monitoring
The TetraGraph TOF monitor will be used to quantitatively assess the TOF-ratio. Quantitative monitoring includes objective measurement of the TOF-ratio, as defined by the ratio between the first and the fourth muscular responses and is quantified by acceleromyography. A TOF twitch response ratio equal or greater to 95% (TOF0.95) will be targeted prior to extubation. If TOF0.95 is not reached within 10 min of administering the initial dose of the respective reversal agent, redosing is recommended - Other Qualitative monitoring
Clinicians will assess the TOF-ratio. Qualitative monitoring includes subjective assessment of the count and the amplitude of the muscular responses related to neuromuscular block depth. A TOF twitch response count of 4 similarly strong twitches will be targeted prior to extubation. If 4 similarly strong TOF twitch responses are not reached within 10 min of administering the initial dose of the respective reversal agent, redosing is recommended.
Primary outcome measures
- lowest SpO2/FiO2 ratio in the PACU (constant for at least 10 minutes) [Time frame: During the time in PACU (about 30 minutes to 6 hours)]
Secondary outcome measures (1)
- Collapsed composite (any vs none) of postoperative pulmonary complications [Time frame: During length of hospital stay (about 1 day to a week)]
Eligibility criteria
Inclusion criteria
- Patient age ≥ 18 years old;
- General anesthesia with endotracheal intubation;
- Neuromuscular block with rocuronium.
Exclusion criteria
- Intubation before induction of anesthesia;
- Critically ill patients admitted from the ICU;
- Emergency cases;
- Non-intubated patients;
- Patients who will not be paralyzed through the surgery (spine).
- Patients with an implanted electronic device (e.g. cardiac pacemaker)
- Patients with allergies to adhesive
- Patients with pre-existing neuromuscular disease (e.g. Myasthenia Gravis)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
United States · 1 center
- The University of Texas Health Science Center at Houston — Houston
Identifiers
NCT: NCT07084363 · HSC-MS-25-0337