Can a smart breathing monitor make waking up from anesthesia safer?
NCT ID NCT06975553
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether a special breathing monitor, called the Integrated Pulmonary Index (IPI), can help doctors decide the safest time to remove a breathing tube after surgery. About 632 adults having planned abdominal surgery will be randomly assigned to either standard care or IPI-guided care. The goal is to see if the IPI monitor reduces the chance of low oxygen levels and other breathing problems in the recovery room.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- endotracheal intubation-type end-tidal carbon dioxide sampling tube (device)
- What this could lead to
- If successful, this could provide a simple, non-invasive way to reduce the risk of dangerously low oxygen levels after surgery.
- What could go wrong
- This is a relatively small, early-stage trial focused on a specific monitoring device. It may not show a clear benefit over standard care, and results may not apply to all types of surgery or patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 632 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2025
- Expected to finish
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Sep 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion criteria: 1. Patients aged 18 years and above and under 80 years old, with ASA classification of I - III, who received general anesthesia and tracheal intubation at the anesthesia recovery unit (PACU) of multiple centers such as the First Medical Center of the Chinese People's Liberation Army General Hospital, and planned for elective abdominal surgery (including digestive system surgeries in general surgery, gynecological surgeries, hepatobiliary surgeries, or urological surgeries), with a surgery duration of 1 hour or more and less than 4 hours, during the period from April 2025 to April 2026. 2. Have signed the informed consent form. Exclusion criteria: 1. Patients whose tracheal intubation was removed before entering the anesthesia recovery room. 2. Patients with preoperative indoor air oxygen saturation (SpO₂) lower than 95%, or those who failed to enter the anesthesia recovery room due to any reason after surgery. 3. Patients with a history of sleep apnea. 4. Patients who have undergone two surgeries within one month. 5. Patients with a history of neuromuscular dysfunction. 6. Patients with mental or cognitive disorders; those with a history of abuse of psychotropic or anesthetic drugs; or those with communication disorders. 7. Patients who cannot cooperate with the clinical trial. Exclusion criteria as follows: 1. Patients who developed severe arrhythmia after entering the anesthesia recovery room. 2. Patients who were delayed in extubation after entering the anesthesia recovery room due to medical conditions (such as waiting for frozen section results, experiencing massive bleeding, etc.). 3. Patients who required another surgery after extubation in the anesthesia recovery room.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Medtronic 20p
Beijing, Beijing Municipality, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can a nasal oxygen device prevent dangerous dips in blood oxygen during endoscopy for COPD patients?
- Warm oxygen may shield patients from Post-Surgery breathing danger
- Breath test could replace needles for checking pulse oximeters