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

NCT06754670 | Recruiting

• 1 other identifier: K6646
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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. 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. 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. 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. 4.24h 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

Outcome Measures

Primary Outcomes (1)

• Neural-excursion efficiency

  Diaphragm excursion/diaphragm potential

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

Study Arms (2)

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

Sodium Glycerophosphate 216 MG/ML DRUG

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.

Hypophosphatemia group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Mechanical ventilation patients in the weaning stage

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking Union Medical College: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, 100730, China

RECRUITING

MeSH Terms

Conditions

Hypophosphatemia

Interventions

alpha-glycerophosphoric acid

Condition Hierarchy (Ancestors)

Phosphorus Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Shitong Diao, MD

CONTACT

86-13833117878; diaost@foxmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 23, 2024
• First Posted: January 1, 2025
• Study Start: October 1, 2024
• Primary Completion: April 1, 2025
• Study Completion: August 1, 2025
• Last Updated: May 31, 2025

Record last verified: 2025-05

Locations

CN (1)