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Completed

NCT Number: NCT06371378

Effect of Different Peep Values on Gastric Residual Volume

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ankara City Hospital

Ankara, Çankaya, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PEEP 0

Procedure

PEEP 0 CMH20 will be used During Surgery

Other names: antrum diamater radio , gastric reziduel volume

PEEP 4

Procedure

PEEP 4 CMH20 will be used During Surgery

PEEP 8

Procedure

PEEP 8 CMH20 will be used During Surgery

Primary outcomes

  1. Gastric antrum diameter

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

    Cross-sectional area (CSA) (cm2)

Secondary outcomes

  1. Intraabdominal pressure (IAP) measurement

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

    Comparing IAP between three groups.

  2. gastric volume measurement

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

    gastric volume (ml)

Other outcomes

  1. Vital parameters Pulse oximetry (%)

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

    Pulse oximetry (%)

  2. Vital parameters systolic and diastolic blood pressure (mmHg)

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

    systolic and diastolic blood pressure (mmHg)

  3. Vital parameters heart rate (beats/minute)

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

    heart rate (beats/minute)

Sponsors and collaborators

Lead sponsor

Ankara City Hospital Bilkent

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Apr 17, 2024
Registry last updated
Oct 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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