Effect of Different Peep Values on Gastric Residual Volume

NCT06371378 | Completed

• 1 other identifier: gastric residual volume
• Study Type: interventional
• Target: 111
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Aspiration of Gastric Content

Keywords

prone position; Gastric POCUS (Point of Care Ultrasound); antrum diameter; risk of pulmonary aspiration; different peep levels

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Intraabdominal pressure (IAP) measurement

  induction of anaesthesia at 0 minutes,After induction of anaesthesia at 1 minutes,at 10 minutes at the end of the case

• gastric volume measurement

  induction of anaesthesia at 0 minutes,After induction of anaesthesia at 1 minutes,at 10 minutes at the end of the case

Other Outcomes (3)

• Vital parameters Pulse oximetry (%)

  induction of anaesthesia at 0 minutes,After induction of anaesthesia at 1 minutes,at 10 minutes at the end of the case

• Vital parameters 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

• Vital parameters 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

Study Arms (3)

GROUP I: PEEP 0

ACTIVE COMPARATOR

Patients will receive 0 cmH20 PEEP

Procedure: PEEP 0

GROUP II: PEEP 4

ACTIVE COMPARATOR

Patients will receive 4 cmH20 PEEP

Procedure: PEEP 4

GROUP III: PEEP 8

ACTIVE COMPARATOR

Patients will receive 8 cmH20 PEEP

Procedure: PEEP 8

Interventions

PEEP 0 PROCEDURE

PEEP 0 CMH20 will be used During Surgery

Also known as: antrum diamater radio , gastric reziduel volume

GROUP I: PEEP 0

PEEP 4 PROCEDURE

PEEP 4 CMH20 will be used During Surgery

GROUP II: PEEP 4

PEEP 8 PROCEDURE

PEEP 8 CMH20 will be used During Surgery

GROUP III: PEEP 8

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age
• ASA I-II risk group

You may not qualify if:

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

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara City Hospital

Ankara, Çankaya, Turkey (Türkiye)

Location

Related 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.

  PMID: 27072147 BACKGROUND

• 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.

  PMID: 36895001 BACKGROUND

• 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.

  PMID: 33456894 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: single blind
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: We gave three different peep values on the mechanic ventilator; 3 groups: Group I: PEEP O, Group II: PEEP 4, Group III: PEEP 8

Study Record Dates

• First Submitted: February 1, 2024
• First Posted: April 17, 2024
• Study Start: February 5, 2024
• Primary Completion: July 29, 2024
• Study Completion: September 1, 2024
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)