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Effectiveness and Safety of Sitting Position in Mechanically Ventilated Patients with Obesity and Central Obesity During Difficult Weaning

Effectiveness and Safety of Sitting Position in Mechanically Ventilated Patients with Obesity and Central Obesity During Difficult Weaning

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600127342
Enrollment
Unknown
Registered
2026-06-30
Start date
2026-07-01
Completion date
Unknown
Last updated
2026-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

mechanically ventilated patients with Obesity or central obesity

Interventions

Sitting-position SBT group:Switch to a sitting position for SBT
Semirecumbent-position SBT group:Maintain the semirecumbent position for SBT

Sponsors

Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Age >=18 years; 2.Receiving invasive mechanical ventilation for >=24 hours; 3.Meeting the criteria for obesity and central obesity, defined as either of the following: BMI >=28 kg/m^2, plus at least one body habitus measurement meeting the following thresholds: waist circumference >=90 cm for men or >=85 cm for women; waist-to-hip ratio >=0.90 for men or >=0.85 for women; waist-to-height ratio >=0.50; or Regardless of BMI, at least two body habitus measurements meeting the following thresholds: waist circumference >=90 cm for men or >=85 cm for women; waist-to-hip ratio >=0.90 for men or >=0.85 for women; waist-to-height ratio >=0.50; 4.Through weaning screening, the evaluation criteria include: (1) Improvement or removal of the cause leading to mechanical ventilation; (2) Oxygenation indicators: PaO2/FiO2 >= 150 mmHg, PEEP = 7.35; for COPD patients, pH >= 7.30, FiO2 = 50 mmHg; (3) Hemodynamic stability, no dynamic changes of myocardial ischemia, clinically no significant hypotension (no or low-dose vasoactive drugs, MAP = 65 mmHg), heart rate 105; (2) RR 35 breaths/min; (3) Heart rate >140 beats/min or changes >20%, new onset arrhythmia; (4) Vt <4 ml/kg during spontaneous breathing; (5) SaO2 <90%. Or when patients show changes in mental status (such as drowsiness, coma, excitement, anxiety), sweating, increased work of breathing (using accessory respiratory muscles, paradoxical breathing). Subjects who successfully completed SBT were excluded; 6.Voluntary participation and signed informed consent. If a subject is unable to read or sign the informed consent form due to reasons such as lack of capacity, the informed consent process must be conducted by their guardian on their behalf, and the guardian must sign the informed consent form. If the subject is unable to read the informed consent form (e.g., illiterate subjects), a witness must witness the informed consent process and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1.Acute myocardial ischemia, severe arrhythmia, or requirement for high-dose vasoactive support; 2.Marked impaired consciousness or inability to cooperate (e.g., RASS <-2), or neuromuscular disease severely affecting spontaneous breathing; 3.Large volume of airway secretions, requiring frequent suctioning and ineffective cough for secretion clearance; 4.High risk of aspiration (e.g., persistent vomiting or uncontrolled upper gastrointestinal bleeding), or recent major thoracic or abdominal surgery limiting position change. 5.Back or spinal structural abnormalities preventing the patient from assuming a sitting position; 6.Unplanned extubation or situations requiring immediate extubation (e.g., endotracheal tube malposition or other special circumstances); 7.Vulnerable populations other than elderly, illiterate, or critically ill patients, such as patients with psychiatric disorders, cognitive impairment, or pregnant women; 8.Any other condition that, in the investigator’s judgment, makes the participant unsuitable for participation in this study.

Design outcomes

Primary

MeasureTime frame
Duration of invasive mechanical ventilation;

Secondary

MeasureTime frame
reintubation within 72 hours;ICU and total hospital stay;Respiratory failure after tube removal;Incidence of respiratory infections;

Countries

China

Contacts

Public ContactHuiqing Ge

Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University

gehq@zju.edu.cn+86 571 86006855

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jul 23, 2026