Clinical trial NCT06371378: Effect of Different Peep Values on Gastric Residual Volume
Official title: Evaluation of the Effect of Different Peep Values on Gastric Residual Volume and Pulmonary Aspiration Risk in Patients Undergoing Spinal Surgery in Prone Position
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Aspiration of Gastric Content
Keywords: prone position
Gastric POCUS (Point of Care Ultrasound)
antrum diameter
risk of pulmonary aspiration
different peep levels
Lead sponsor: Ankara City Hospital Bilkent
Sponsor class: OTHER
First posted: 2024-04-17
Enrollment: 111
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: We gave three different peep values on the mechanic ventilator; 3 groups: Group I: PEEP O, Group II: PEEP 4, Group III: PEEP 8
Primary purpose: TREATMENT

Brief summary: The aim of this study was to predict the effect of gastric antrum diameter before extubation on intra-abdominal pressure changes and consequently on the risk of pulmonary aspiration in patients undergoing elective spinal surgery under general anaesthesia in the prone position in the Neurosurgery Operating Theatre of the Ministry of Health Ankara City Hospital and to take precautions accordingly. Gastric antrum diameter and intraabdominal pressure measurements may contribute to the improvement of anaesthetic practice by reducing the risk of pulmonary aspiration and additional complications.

Detailed description: Prone positioning in spinal surgery is a very important issue for anaesthetists. Although there are many conditions that are taken into consideration in patient follow-up, it is a position frequently used in the treatment of pulmonary diseases other than surgery. PEEP application in the prone position is especially used in the treatment of conditions such as acute respiratory distress syndrome (ARDS). This treatment method basically aims to improve oxygenation and ventilation in the lungs. While providing improvement in the lungs, it may indirectly lead to some changes in the gastrointestinal system. Depending on PEEP levels, intra-abdominal pressure may increase and subsequently cause reflux of gastric contents or gastroparesis. The prone position itself also increases the risk of reflux. Gastric POCUS (Point of Care Ultrasound) is a noninvasive method that gives us information about the stomach contents and can be easily performed at the bedside. Both patient position and respiratory parameters, such as PEEP, may have an effect on gastric POCUS. Visualization of gastric content or detection of gastric retention allows us to predict possible pulmonary aspiration complications before extubation, and gastric POCUS may be a valuable marker before extubation in patients who remain in prone positions for a long time. The aim of this study was to determine the effect of PEEP application on the antrum diameter evaluated by gastric POCUS and the risk of aspiration before extubation in patients undergoing spinal surgery in the prone position.

Eligibility criteria: Inclusion Criteria

* 18-65 years of age
* ASA I-II risk group

Exclusion Criteria:

* Asthma
* COPD
* Gastroesophageal reflux
* Gastric herniation
* Gastric surgery,
* Intracranial tumor
* Epilepsy
* Neuromuscular disease

Primary outcomes:
measure: Gastric antrum diameter
timeFrame: induction of anaesthesia at 0 minutes,After induction of anaesthesia at 1 minutes,at 10 minutes at the end of the case
Secondary outcomes:
measure: Intraabdominal pressure (IAP) measurement
timeFrame: induction of anaesthesia at 0 minutes,After induction of anaesthesia at 1 minutes,at 10 minutes at the end of the case
measure: gastric volume measurement
timeFrame: induction of anaesthesia at 0 minutes,After induction of anaesthesia at 1 minutes,at 10 minutes at the end of the case
Other outcomes:
measure: Vital parameters Pulse oximetry (%)
timeFrame: induction of anaesthesia at 0 minutes,After induction of anaesthesia at 1 minutes,at 10 minutes at the end of the case
measure: Vital parameters systolic and diastolic blood pressure (mmHg)
timeFrame: induction of anaesthesia at 0 minutes,After induction of anaesthesia at 1 minutes,at 10 minutes at the end of the case
measure: Vital parameters heart rate (beats/minute)
timeFrame: induction of anaesthesia at 0 minutes,After induction of anaesthesia at 1 minutes,at 10 minutes at the end of the case
Locations:
city: Ankara
country: Turkey
facility: Ankara City Hospital
state: Çankaya
Study officials:
References:
citation: Chui J, Craen RA. An update on the prone position: Continuing Professional Development. Can J Anaesth. 2016 Jun;63(6):737-67. doi: 10.1007/s12630-016-0634-x. Epub 2016 Apr 12.
citation: Fujishima S. Guideline-based management of acute respiratory failure and acute respiratory distress syndrome. J Intensive Care. 2023 Mar 10;11(1):10. doi: 10.1186/s40560-023-00658-3.
citation: El-Boghdadly K, Wojcikiewicz T, Perlas A. Perioperative point-of-care gastric ultrasound. BJA Educ. 2019 Jul;19(7):219-226. doi: 10.1016/j.bjae.2019.03.003. Epub 2019 Apr 24. No abstract available.