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RecruitingNCT06754670Updated May 31, 2025

Effect of Hypophosphatemia on Neuro-excursion Efficiency During Mechanical Ventilator Weaning

An observational study in Mechanical Ventilation, Weaning Failure and Hypophosphatemia, sponsored by Peking Union Medical College. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-31.

Sponsored by Peking Union Medical College · Observational

From the registry’s dates

  • Started Oct 2024; still recruiting 2 years 1 month later.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
70
Ages
18 Years and older
Sex
All
01

Study 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. 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.

  1. 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.)
  2. 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.
  3. 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.
  4. 24h after the first CPAP offline, patients in both groups repeated the CPAP offline process, collected related parameters, and measured blood inorganic phosphorus.
02

Conditions studied

  • Mechanical Ventilation
  • Weaning Failure
  • Hypophosphatemia

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03

In context

Hypophosphatemia

53 studies on the registry are indexed under Hypophosphatemia; 16 are open to participants now.

This study's planned enrollment of 70 is below the median of 105 across 26 observational studies indexed under Hypophosphatemia.

Browse Hypophosphatemia studies →

Lead sponsor

Peking Union Medical College is the lead sponsor of 58 studies on the registry; 17 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Mechanical ventilation patients in the weaning stage

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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.

Exclusion criteria

Exclusion criteria:

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 for gastric tube insertion after esophagogastric fundus varices, digestive tract perforation, and upper digestive tract surgery; Pregnant patients; Ultrasonic window is poor.

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
70 participants (estimated)
Patient registry
No

Groups and cohorts

  • Hypophosphatemia group

    On the day of weaning, the patient's peripheral blood phosphorus was low(\<0.8mmol/ L).

    Drug: Sodium Glycerophosphate 216 MG/ML

  • Normal phosphorus group

    On the day of weaning, the patient's peripheral blood phosphorus was normal.

Interventions

  • DrugSodium Glycerophosphate 216 MG/ML

    Drug page: Alpha-glycerophosphoric acid

    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.

06

What researchers measure

Primary outcomes

  1. Neural-excursion efficiency

    Diaphragm excursion/diaphragm potential

    Time frame: 0,1,3,5,10,20,30minutes after initiation of the SBT

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 31, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06754670
Lead sponsor
Peking Union Medical College
Responsible party
Shitong Diao (Principal Investigator, Peking Union Medical College) — Principal investigator
First posted
Jan 1, 2025
Start date
Oct 1, 2024
Primary completion
Apr 1, 2025
Completion
Aug 1, 2025 (estimated)
Last update
May 31, 2025

Study contacts

Shitong Diao, MD
Contact
diaost@foxmail.com
86-13833117878

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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