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A Study on the Impact of Mechanical Ventilation Mode Selection Guided by the BioZ Non-invasive Hemodynamic Monitoring System on Diaphragmatic Function in Overweight or Obese Patients Undergoing Gynecological Laparoscopic Surgery

A Study on the Impact of Mechanical Ventilation Mode Selection Guided by the BioZ Non-invasive Hemodynamic Monitoring System on Diaphragmatic Function in Overweight or Obese Patients Undergoing Gynecological Laparoscopic Surgery

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600122279
Enrollment
Unknown
Registered
2026-04-10
Start date
2026-04-10
Completion date
Unknown
Last updated
2026-04-14

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

Conditions

Gynecological Laparoscopic Operation

Interventions

BioZ-guided Group:Following induction of anesthesia, the BioZ non-invasive hemodynamic monitoring system (BioZ.com, CardioDynamics, San Diego, CA, USA) was continuously connected throughout the entire
Conventional Ventilation Group:Patients in this group were managed without the BioZ monitoring system. Following induction of anesthesia, the VCV mode was initially employed. After the establishment o

Sponsors

Anesthesiology Department of Zhongnan Hospital of Wuhan University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Age: 18–65 years; 2.Body Mass Index (BMI): 24–35 kg/m^2; 3.ASA Physical Status: Class I–III; 4.Type of Surgery: Elective gynecological laparoscopic surgery (e.g., laparoscopic myomectomy, ovarian cystectomy, and total hysterectomy); 5.Estimated Duration of Pneumoperitoneum: >=60 minutes.

Exclusion criteria

Exclusion criteria: 1.Major Organ Dysfunction: Including severe cardiac insufficiency (NYHA Class III/IV), severe hepatic insufficiency (Child-Pugh Class C), and severe renal impairment (eGFR 9%) or uncontrolled hypertension (SBP > 180 mmHg). 5.Abdominal Conditions: Intra-abdominal hypertension (IAP > 12 mmHg), massive ascites, or a history of abdominal surgery likely to affect diaphragmatic movement. 6.Pre-existing Sleep Apnea: Preoperative moderate-to-severe obstructive sleep apnea (OSA, STOP-Bang score >= 5). 7.Surgical History: History of thoracic or upper abdominal surgery within the past 6 months. 8.Nutritional Status: Preoperative severe malnutrition (serum albumin = 4). 9.Others: Emergency surgery, pregnant or lactating women, known allergy to study medications, participation in other interventional clinical trials, or any condition deemed unsuitable by the investigator (e.g., communication barriers).

Design outcomes

Primary

MeasureTime frame
The incidence of postoperative pulmonary complications (PPCs) within the first 3 postoperative days.;The incidence of early postoperative diaphragmatic dysfunction (as assessed by ultrasound).;

Secondary

MeasureTime frame
Hemodynamic Parameters;Respiratory Mechanics Indicators;Postoperative extubation time;Awakening time;Discharge time;hospital stays;

Countries

China

Contacts

Public ContactJianjuan Ke

Zhongnan Hospital of Wuhan University

kejianjuan@whu.edu.cn+86 139 7168 7409

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 17, 2026