Mechanical VentilationNCT06754670
Effect of Hypophosphatemia on Neuro-excursion Efficiency During Mechanical Ventilator Weaning
An observational study of Mechanical Ventilation and Weaning Failure, run by Peking Union Medical College at 1 site in China.
Trial summary
Hypophosphatemia is a common phenomenon in the ICU, and several retrospective studies have shown that hypophosphatemia is associated with prolonged mechanical ventilation in ICU patients. However, the specific mechanism and causal relationship are not clear. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mechanical Ventilation, Weaning Failure, Hypophosphatemia
- What is being tested?
- Sodium Glycerophosphate 216 MG/ML
- Type of treatment
- Injection or infusion
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2024to 1 Aug 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Mechanical ventilation patients in the weaning stage
Who may be able to join
- age ≥18 years old; Acute respiratory failure, tracheal intubation patients; Invasive ventilator use time ≥48 hours; Clinically determined remission of primary disease, has switched to auxiliary ventilation mode and plans to go offline in the near future.
Who cannot join
- patients with severe neuromuscular disease; Patients with central system diseases; Patients using muscle relaxants for more than 48 hours; Patients who have been or are about to be discontinued from life support; Patients with contraindications for gastric tube insertion after esophagogastric fundus varices, digestive tract perforation, and upper digestive tract surgery; Pregnant patients; Ultrasonic window is poor.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, 100730
Jiayue Li, pumchkyc@126.com
About this study
Official title: Hypophosphatemia in Wean
Hypophosphatemia is a common phenomenon in the ICU, and several retrospective studies have shown that hypophosphatemia is associated with prolonged mechanical ventilation in ICU patients. However, the specific mechanism and causal relationship are not clear. Previous studies have shown that phosphate infusion improves the contraction of the diaphragm induced by exogenous electrical stimulation, but the effect of hypophosphatemia and phosphate supplementation on the pathophysiology in decannulated patients on mechanical ventilation has not been confirmed. The study group hypothesized that hypophosphatemia affects neural conduction function and muscle contraction by affecting ATP synthesis. Correcting hypophosphatemia may improve respiratory muscle strength and potentially improve diaphragmatic neural conduction, ultimately improving the patient's neuromuscular conversion efficiency and facilitating discharge.
- The attending physician evaluates the patient's ventilator condition daily and meets the disconnection criteria (spontaneous breathing, RSBI < 105 (min*ml)-1, stable hemodynamics: norepinephrine or epinephrine ≤ 0.1μg/kg/min, PEEP ≤ 8cmH2O, FiO2 ≤ 50%, no increase in ventilator support conditions in the past 24 hours, PS 10cmH2O, MAAS score 2-4, pH ≥ 7.30, discontinuation of all sedative medications). After signing an informed consent form, a diaphragm electromyography (EEG) catheter is placed. (The diaphragm EEG catheter is a gastric tube with diaphragm electromyography monitoring function, with the same placement process and risks as a regular gastric tube. There is a small probability of complications such as nasal mucosal damage.)
- Start CPAP disconnection: Adjust the ventilator PS 10 → 0 cmH2O, and keep the other conditions unchanged. Collect ventilator parameters, diaphragm electromyography (EAdi) parameters, and diaphragm ultrasound parameters at 0, 1, 3, 5, 10, 20, and 30 minutes after the trial begins, and collect the maximum EAdi and diaphragm ultrasound during quiet state.
- Simultaneously monitor blood inorganic phosphorus, and divide the patients into two groups: the low phosphorus group (<0.8mmol/L) and the control group (0.8-1.4 mmol/L). Low phosphorus patients receive intravenous phosphate supplementation according to the clinical phosphate supplementation protocol at our center [1-5]: patients with blood phosphorus < 0.4mmol/L receive 40mmol of glycerol phosphate sodium intravenously via infusion or injection over 4-6 hours; patients with blood phosphorus 0.4-0.8mmol/L receive 30mmol of glycerol phosphate sodium intravenously via infusion or injection; Normal phosphorus patients do not require any special treatment.
- 24h after the first CPAP offline, patients in both groups repeated the CPAP offline process, collected related parameters, and measured blood inorganic phosphorus.
- Conditions
- Mechanical Ventilation, Weaning Failure, Hypophosphatemia
- Being tested
- Sodium Glycerophosphate 216 MG/ML
- Medical subject headings
- Hypophosphatemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium Glycerophosphate 216 MG/MLDrug
Low phosphorus patients receive intravenous phosphate supplementation according to the clinical phosphate supplementation protocol at our center: patients with blood phosphorus < 0.4mmol/L receive 40mmol of glycerol phosphate sodium intravenously via infusion or injection over 4-6 hours; patients with blood phosphorus 0.4-0.8mmol/L receive 30mmol of glycerol phosphate sodium intravenously via infusion or injection; Normal phosphorus patients do not require any special treatment.
| Study group | Role | What they receive |
|---|---|---|
| Hypophosphatemia group | On the day of weaning, the patient's peripheral blood phosphorus was low(<0.8mmol/ L). Receives: Drug: Sodium Glycerophosphate 216 MG/ML | |
| Normal phosphorus group | On the day of weaning, the patient's peripheral blood phosphorus was normal. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neural-excursion efficiency
Diaphragm excursion/diaphragm potential
Measured: 0,1,3,5,10,20,30minutes after initiation of the SBT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2025
- Study start1 Oct 2024
- Primary completion1 Apr 2025
- Study completion1 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanical VentilationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shitong Diao, Peking Union Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06754670
- Sponsor's protocol ID
- K6646
- Status last verified
- May 2025
- First submitted
- 23 Dec 2024
- Last updated
- 31 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypophosphatemia in Wean
- ClinicalTrials.gov ID
- NCT06754670
- Acronym / sponsor ID
- K6646
- Conditions
- Mechanical Ventilation, Weaning Failure, Hypophosphatemia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Peking Union Medical CollegeUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 1 Apr 2025 (actual)
- Study completion
- 1 Aug 2025 (estimated)
- First posted
- 1 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hypophosphatemia is a common phenomenon in the ICU, and several retrospective studies have shown that hypophosphatemia is associated with prolonged mechanical ventilation in ICU patients. However, the specific mechanism and causal relationship are not clear. Previous studies have shown that phosphate infusion improves the contraction of the diaphragm induced by exogenous electrical stimulation, but the effect of hypophosphatemia and phosphate supplementation on the pathophysiology in decannulated patients on mechanical ventilation has not been confirmed. The study group hypothesized that hypophosphatemia affects neural conduction function and muscle contraction by affecting ATP synthesis. Correcting hypophosphatemia may improve respiratory muscle strength and potentially improve diaphragmatic neural conduction, ultimately improving the patient's neuromuscular conversion efficiency and facilitating discharge.
- The attending physician evaluates the patient's ventilator condition daily and meets the disconnection criteria (spontaneous breathing, RSBI < 105 (min*ml)-1, stable hemodynamics: norepinephrine or epinephrine ≤ 0.1μg/kg/min, PEEP ≤ 8cmH2O, FiO2 ≤ 50%, no increase in ventilator support conditions in the past 24 hours, PS 10cmH2O, MAAS score 2-4, pH ≥ 7.30, discontinuation of all sedative medications). After signing an informed consent form, a diaphragm electromyography (EEG) catheter is placed. (The diaphragm EEG catheter is a gastric tube with diaphragm electromyography monitoring function, with the same placement process and risks as a regular gastric tube. There is a small probability of complications such as nasal mucosal damage.)
- Start CPAP disconnection: Adjust the ventilator PS 10 → 0 cmH2O, and keep the other conditions unchanged. Collect ventilator parameters, diaphragm electromyography (EAdi) parameters, and diaphragm ultrasound parameters at 0, 1, 3, 5, 10, 20, and 30 minutes after the trial begins, and collect the maximum EAdi and diaphragm ultrasound during quiet state.
- Simultaneously monitor blood inorganic phosphorus, and divide the patients into two groups: the low phosphorus group (<0.8mmol/L) and the control group (0.8-1.4 mmol/L). Low phosphorus patients receive intravenous phosphate supplementation according to the clinical phosphate supplementation protocol at our center [1-5]: patients with blood phosphorus < 0.4mmol/L receive 40mmol of glycerol phosphate sodium intravenously via infusion or injection over 4-6 hours; patients with blood phosphorus 0.4-0.8mmol/L receive 30mmol of glycerol phosphate sodium intravenously via infusion or injection; Normal phosphorus patients do not require any special treatment.
- 24h after the first CPAP offline, patients in both groups repeated the CPAP offline process, collected related parameters, and measured blood inorganic phosphorus.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hypophosphatemia group | – | Drug: Sodium Glycerophosphate 216 MG/MLOn the day of weaning, the patient's peripheral blood phosphorus was low(<0.8mmol/ L). |
| Normal phosphorus group | – | –On the day of weaning, the patient's peripheral blood phosphorus was normal. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Mechanical ventilation patients in the weaning stage
Key inclusion criteria (1 listed)
- age ≥18 years old; Acute respiratory failure, tracheal intubation patients; Invasive ventilator use time ≥48 hours; Clinically determined remission of primary disease, has switched to auxiliary ventilation mode and plans to go offline in the near future.
Key exclusion criteria (1 listed)
- patients with severe neuromuscular disease; Patients with central system diseases; Patients using muscle relaxants for more than 48 hours; Patients who have been or are about to be discontinued from life support; Patients with contraindications for gastric tube insertion after esophagogastric fundus varices, digestive tract perforation, and upper digestive tract surgery; Pregnant patients; Ultrasonic window is poor.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sodium Glycerophosphate 216 MG/MLLow phosphorus patients receive intravenous phosphate supplementation according to the clinical phosphate supplementation protocol at our center: patients with blood phosphorus < 0.4mmol/L receive 40mmol of glycerol phosphate sodium intravenously via infusion or injection over 4-6 hours; patients with blood phosphorus 0.4-0.8mmol/L receive 30mmol of glycerol phosphate sodium intravenously via infusion or injection; Normal phosphorus patients do not require any special treatment. | Drug | Hypophosphatemia group |
Primary outcome
Neural-excursion efficiency
Time frame: 0,1,3,5,10,20,30minutes after initiation of the SBT
Diaphragm excursion/diaphragm potential
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mechanical Ventilation and Weaning Failure, run by Peking Union Medical College at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shitong Diao, MD (86-13833117878, diaost@foxmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neural-excursion efficiency (time frame: 0,1,3,5,10,20,30minutes after initiation of the SBT). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2025.