Clinical trial NCT05627024: Effects of Different Inhalation Oxygen Concentrations on Postoperative Atelectasis
Official title: Effects of Different Inhalation Oxygen Concentrations on Oxygenation Index and Immediately Postoperative Atelectasis in Neurosurgery Patients. DIOCA-Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Atelectasis
Lead sponsor: China Medical University, China
Sponsor class: OTHER
First posted: 2022-11-25
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study was a single-center, prospective, randomized controlled, two-arm study. This study will be conducted in the First Hospital of China Medical University. the investigators aimed to investigate the effects of different inspired oxygen concentrations in lung protective ventilation strategies on immediate postoperative atelectasis and intraoperative changes of oxygenation index in patients undergoing neurosurgical surgery in the supine position.

Detailed description: This study was a single-center, prospective, randomized controlled, two-arm study. This study will be conducted in the First Hospital of China Medical University. the investigators aimed to investigate the effects of different inspired oxygen concentrations in lung protective ventilation strategies on immediate postoperative atelectasis and intraoperative changes of oxygenation index in patients undergoing neurosurgical surgery in the supine position. A total of 96 neurosurgical patients under supine position were selected with an estimated operation time of more than 2 hours. Patients were randomly assigned to low-oxygen concentration (30%FiO2) L group, or high-oxygen concentration (60%FiO2) H group, and both groups received lung protective ventilation strategies. The main outcome was the comparison of postoperative atelectasis volume between the two groups. Secondary outcomes were the comparison of intraoperative oxygenation index and postoperative changes in diaphragm height between the two groups.

Eligibility criteria: Inclusion Criteria:

* patients with American Society of Anesthesiologist (ASA) physical status I-II;
* Older than 18 years; Patients with operation time more than 2 hours and plan to extubate in the operating room;
* Preoperative blood gas partial pressure of oxygen was more than 80mmHg;
* Patients scheduled for elective neurosurgery were operated in the supine position.

Exclusion Criteria:

* A history of acute lung injury with acute respiratory distress syndrome within three months;
* Heart failure (New York Heart Association class) greater than IV, severe liver and kidney dysfunction (Child B or C liver failure, glomerular filtration rate \<30ml/min);
* BMI \> 30 kg/m2.
* The operation time is more than 10 hours;
* The amount of bleeding was more than 500ml; The total fluid volume exceeded 3000ml.

Primary outcomes:
measure: the occurrence of atelectasis
timeFrame: On the operating room within 40 minutes after awakening
Secondary outcomes:
measure: oxygenation index
timeFrame: On the operating room within 40 minutes after awakening
measure: bilateral diaphragmatic muscles
timeFrame: On the operating room within 40 minutes after awakening
Other outcomes:
Locations:
city: Shenyang
country: China
facility: the First Hospital of China Medical University
state: Liaoning
Study officials:
References: