Respiratory Aspiration of Gastric ContentNCT06371378
Effect of Different Peep Values on Gastric Residual Volume
A study testing PEEP 0, PEEP 4 and PEEP 8 in people with Respiratory Aspiration of Gastric Content, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Respiratory Aspiration of Gastric Content
- What is being tested?
- PEEP 0, PEEP 4 and PEEP 8
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Feb 2024to 1 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-65 years of age
- ASA I-II risk group
Who cannot join
- Asthma
- COPD
- Gastroesophageal reflux
- Gastric herniation
- Gastric surgery,
- Intracranial tumor
- Epilepsy
- Neuromuscular disease
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Being tested
- PEEP 0, PEEP 4, PEEP 8
- Keywords
- prone position, Gastric POCUS (Point of Care Ultrasound), antrum diameter, risk of pulmonary aspiration, different peep levels
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEEP 0Procedure or surgery
Also called antrum diamater radio , gastric reziduel volume
PEEP 0 CMH20 will be used During Surgery
PEEP 4Procedure or surgery
PEEP 4 CMH20 will be used During Surgery
PEEP 8Procedure or surgery
PEEP 8 CMH20 will be used During Surgery
| Study group | Role | What they receive |
|---|---|---|
| GROUP I: PEEP 0 | Active comparator | Patients will receive 0 cmH20 PEEP Receives: Procedure: PEEP 0 |
| GROUP II: PEEP 4 | Active comparator | Patients will receive 4 cmH20 PEEP Receives: Procedure: PEEP 4 |
| GROUP III: PEEP 8 | Active comparator | Patients will receive 8 cmH20 PEEP Receives: Procedure: PEEP 8 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastric antrum diameter
Cross-sectional area (CSA) (cm2)
Measured: 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
Comparing IAP between three groups.
Measured: 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
gastric volume (ml)
Measured: induction of anaesthesia at 0 minutes,After induction of anaesthesia at 1 minutes,at 10 minutes at the end of the case
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2024
- Study start5 Feb 2024
- Primary completion29 Jul 2024
- Study completion1 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Respiratory Aspiration of Gastric ContentStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Süleyman Taygurt, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06371378
- Sponsor's protocol ID
- gastric residual volume
- Status last verified
- Oct 2024
- First submitted
- 1 Feb 2024
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 27072147Fujishima 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.
PubMed 36895001El-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.
PubMed 33456894
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06371378
- Acronym / sponsor ID
- gastric residual volume
- Keywords
- prone position, Gastric POCUS (Point of Care Ultrasound), antrum diameter, risk of pulmonary aspiration, different peep levels
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 5 Feb 2024 (actual)
- Primary completion
- 29 Jul 2024 (actual)
- Study completion
- 1 Sep 2024 (actual)
- First posted
- 17 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 3
- 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
| Arm | Type | Receives |
|---|---|---|
| GROUP I: PEEP 0 | Active comparator | Procedure: PEEP 0Patients will receive 0 cmH20 PEEP |
| GROUP II: PEEP 4 | Active comparator | Procedure: PEEP 4Patients will receive 4 cmH20 PEEP |
| GROUP III: PEEP 8 | Active comparator | Procedure: PEEP 8Patients will receive 8 cmH20 PEEP |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18-65 years of age
- ASA I-II risk group
Key exclusion criteria (8 listed)
- Asthma
- COPD
- Gastroesophageal reflux
- Gastric herniation
- Gastric surgery,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PEEP 0Also: antrum diamater radio , gastric reziduel volumePEEP 0 CMH20 will be used During Surgery | Procedure or surgery | GROUP I: PEEP 0 |
| PEEP 4PEEP 4 CMH20 will be used During Surgery | Procedure or surgery | GROUP II: PEEP 4 |
| PEEP 8PEEP 8 CMH20 will be used During Surgery | Procedure or surgery | GROUP III: PEEP 8 |
Primary outcome
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)
2 secondary outcomes
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Background: PubMed 27072147Chui 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.
- Background: PubMed 36895001Fujishima 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.
- Background: PubMed 33456894El-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PEEP 0, PEEP 4 and PEEP 8 in people with Respiratory Aspiration of Gastric Content, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06371378, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024.