Effect of Different Peep Values on Gastric Residual Volume

Respiratory Aspiration of Gastric Content Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06371378
• Other study ID #: gastric residual volume
• Status: Active, not recruiting
• Start date: February 5, 2024
• Est. completion date: September 1, 2024

Study information

• Verified date: April 2024
• Source: Ankara City Hospital Bilkent
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 90
• Est. completion date: September 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Respiratory Aspiration
• Respiratory Aspiration of Gastric Content
• Respiratory Aspiration of Gastric Contents

Intervention

Procedure:
• PEEP 0
PEEP 0 CMH20 will be used During Surgery
• PEEP 4
PEEP 4 CMH20 will be used During Surgery
• PEEP 8
PEEP 8 CMH20 will be used During Surgery

Locations

Country	Name	City	State
Turkey	Ankara City Hospital	Ankara	Çankaya

Sponsors (1)

Lead Sponsor	Collaborator
Ankara City Hospital Bilkent

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Vital parameters Pulse oximetry (%)	Pulse oximetry (%)	induction of anaesthesia at 0 minutes,After induction of anaesthesia at 1 minutes,at 10 minutes at the end of the case
Other	Vital parameters systolic and diastolic blood pressure (mmHg)	systolic and diastolic blood pressure (mmHg)	induction of anaesthesia at 0 minutes,After induction of anaesthesia at 1 minutes,at 10 minutes at the end of the case
Other	Vital parameters heart rate (beats/minute)	heart rate (beats/minute)	induction of anaesthesia at 0 minutes,After induction of anaesthesia at 1 minutes,at 10 minutes at the end of the case
Primary	Gastric antrum diameter	Cross-sectional area (CSA) (cm2)	induction of anaesthesia at 0 minutes,After induction of anaesthesia at 1 minutes,at 10 minutes at the end of the case
Secondary	Intraabdominal pressure (IAP) measurement	Comparing IAP between three groups.	induction of anaesthesia at 0 minutes,After induction of anaesthesia at 1 minutes,at 10 minutes at the end of the case
Secondary	gastric volume measurement	gastric volume (ml)	induction of anaesthesia at 0 minutes,After induction of anaesthesia at 1 minutes,at 10 minutes at the end of the case