Oxygenation Index
Conditions
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.
Detailed description
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. the investigators planned to enroll 1098 subjects aged \> 65 years for laparoscopic gastrointestinal surgery at 19 clinical trial centers in China, randomized in a 1:1 ratio, to use two inhaled oxygen concentrations during surgery. All patients will be performed via the lung-protective ventilation strategy. The respiratory parameters are VT: 6-8ml/kg, PEEP: 6-8 cmh2O, RR: 1:2, and respiratory rate will be adjusted by maintaining a partial pressure of carbon dioxide at 35-45 mmHg. Manual lung recruitment maneuvers will be performed after tracheal intubation and before tracheal extubation. The main outcome measure was the oxygenation index on the postoperative 48h. The secondary outcome measures were the 7-day postoperative pulmonary complications and 30-day mortality rates et al.
Interventions
DRUG80% Oxygen
After successful anesthesia induction, the fraction of inspired oxygen (FiO2) will be adjusted to 80%, and the total gas flow rate will be set at 2L/minute.
DRUG40% Oxygen
After successful anesthesia induction, the fraction of inspired oxygen (FiO2) will be adjusted to 40%, and the total gas flow rate will be set at 2L/minute.
Sponsors
China Medical University, China
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Oxygenation Index | On the postoperative 48th hour | The primary outcome was the comparison of the oxygenation index between the two groups. Oxygenation index of acute lung injury is 200, and higher scores mean worse outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| pH value in blood gas analysis 48 hours after the operation | On the postoperative 48th hour | pH of blood gas analysis 48 hours after the operation |
| oxygen inhalation time | On the postoperative 48 hour | oxygen inhalation time |
| inspired oxygen concentration | On the postoperative 48 hour | inspired oxygen concentration |
| oxygen uptake rate | On the postoperative 48 hour | oxygen uptake rate |
| 7 days pulmonary complications | On the postoperative 7th day | 7 days pulmonary complications |
| 30-day Mortality | On the postoperative 30th day | 30-day Mortality |
| PaCO2 in blood gas analysis 48 hours after the operation | On the postoperative 48th hour | PaCO2 of blood gas analysis 48 hours after the operation |
| Lactic acid in blood gas analysis 48 hours after the operation | On the postoperative 48th hour | Lactic acid in blood gas analysis 48 hours after the operation |
Countries
China
Contacts
CONTACTTianhao Zhang, M.D.
CONTACTYang An, M.D.
Outcome results
None listed