NCT06359106 Effects of Different Inhaled Oxygen Concentrations on Lung Function in Older Patients After Laparoscopic Gastrointestinal Surgery Under General Anesthesia
| NCT ID | NCT06359106 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | China Medical University, China |
| Condition | Oxygenation Index |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,176 participants |
| Start Date | 2024-07-02 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 1,176 participants in total. It began in 2024-07-02 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This was a multicenter, prospective, parallel-grouping, randomized controlled clinical study comparing low FiO2 (40%) and high FiO2 (80%) levels in older patients undergoing laparoscopic gastrointestinal surgery.
Eligibility Criteria
Inclusion Criteria: * Age not less than 65 years * American Society of Anesthesiologists grades I-III * No history of drug allergies or abnormal anesthesia. * The duration of mechanical ventilation was expected to be more than 2 hours. * Laparoscopic Gastrointestinal Surgery * The preoperative oxygen saturation was not less than 94%. * The patients will be planned to extubate in the operating room. Exclusion Criteria: * History of acute lung injury or acute respiratory distress syndrome (ARDS) within 3 months. * Cardiac function Class IV (New York Heart Association classification) * Chronic renal failure (renal cell filtration rate \<30 ml min-11.73/m2), severe liver disease * Patients with blurred consciousness and cognitive dysfunction * Severe coagulation dysfunction. * Without preoperative oxygen inhalation, blood oxygen level \<94%, and severe pulmonary dysfunction * Patients with endotracheal tubes were admitted to the intensive care unit (ICU) after surgery. * Body mass index (BMI) \>30kg/m2 * Inability to complete the study
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06359106 clinical trial?
This trial is open to participants of all sexes, aged 65 Years or older, studying Oxygenation Index. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06359106 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06359106 currently recruiting?
Yes, NCT06359106 is actively recruiting participants. Contact the research team at zhth774176947@163.com for enrollment information.
Where is the NCT06359106 trial being conducted?
This trial is being conducted at Shenyang, China, Beijing, China, Chendu, China, Chifeng, China and 11 additional locations.
Who is sponsoring the NCT06359106 clinical trial?
NCT06359106 is sponsored by China Medical University, China. The trial plans to enroll 1,176 participants.