Cholecystitis; GallstoneNCT04723043
The Effect of Ventilation Modes on Cerebral Oxymetry In Operation
A study testing mechanical ventilation modes in people with Cholecystitis; Gallstone and Mechanical Ventilation Pressure High, run by Sisli Hamidiye Etfal Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
In laparoscopic cholecystectomy method, Insufflation of CO2 in abdominal cavity causes positioning of the diaphragm upwards, a decrease in lung's volume and its compliance, an increase in the airway resistance, mismatch between the atelectasis and the ventilation perfusion. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cholecystitis; Gallstone, Mechanical Ventilation Pressure High, Intraabdominal Hypertension
- What is being tested?
- mechanical ventilation modes
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2021to 25 Jun 2021
- 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
- ASA (American Society of Anesthesiology) score of 1 and 2
- body mass index < 30 kg/m2
- planned elective laparoscopic cholecystectomy operation
- 18-65 years old
Who cannot join
- who are applied with emergency laparoscopic cholecystectomy operation
- ASA (American Society of Anesthesiology) score of 3 and above
- hematocrit value 30 and below
- body mass index> 30 kg/m2
- major pulmonary disease (this condition was defined as having capacity and currency flow speed values that are below %70 in respiratory functional tests)
- patients with a history of thoracic surgery
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sisli Etfal Research and Training Hospital
Şişli, Istanbul, 34371
About this study
Official title: The Effect of Pressure Controlled and Volume Controlled Ventilation Modes on Cerebral Oxymetry and Blood Gases In Laparoscopic Cholecystectomy Operations
In laparoscopic cholecystectomy method, Insufflation of CO2 in abdominal cavity causes positioning of the diaphragm upwards, a decrease in lung's volume and its compliance, an increase in the airway resistance, mismatch between the atelectasis and the ventilation perfusion. Although there are numerous studies in laparoscopic surgery, only a few of them investigate the effects of laparoscopic surgery on the cardiopulmonary and the respiratory mechanics. The investigator aimed To examine the effects of pressure-controlled and volume-controlled ventilation modes on cerebral oximetry and blood gases in laparoscopic cholecystectomy operations.
Read the detailed description
Since the laparoscopic methods have been introduced to the surgical operations, laparoscopic cholecystectomy has become the golden standard in gall bladder surgical treatments. In this method, carbon dioxide (CO2) pneumoperitoneum method is used to achieve the desired surgical and visual conditions. Alongside the advantages of the Laparoscopic cholecystectomy method (e.g. shortening the patient's length of stay at the hospital, minimal postoperative pain and rapid recovery), it has various intraabdominal pressure related systemic disadvantages . Insufflation of CO2 in abdominal cavity causes positioning of the diaphragm upwards, a decrease in lung's volume and its compliance, an increase in the airway resistance, mismatch between the atelectasis and the ventilation perfusion. Various ventilation strategies have been introduced to increase arterial oxygenation, functional residual capacity (FRC), and the lung compliance. Recent studies; demonstrates that pressure-controlled mechanical ventilation is superior to volume-controlled mechanical ventilation in providing arterial and tissue oxygenation.
Although there are numerous studies in laparoscopic surgery, only a few of them investigate the effects of laparoscopic surgery on the cardiopulmonary and the respiratory mechanics. Several experimental and clinical studies describe that the cardiovascular effects of the high intraabdominal pressure and the CO2 insufflation is complex. In fact, the results are linked to the studied patients' population, the lung's position and its volume. As it is known in laparoscopic surgeries, the oxygenation in cerebral tissue decreases as the intraabdominal pressure increases. At present, bispectral index (BIS), electroencephalography (EEG), auditory evoke potential (AEP) (and several others) and functional NIRS (fNIRS) are used to measure cerebral oxygenation and anaesthetic depth. NIRS monitorisation makes use of the combined effects of the transmission, the reflection, the dispersion, and the absorption of light. It can also measure the oxygen saturation in tissues that does not have pulsatile circulation. The investigator aimed To examine the effects of pressure-controlled and volume-controlled ventilation modes on cerebral oximetry and blood gases in laparoscopic cholecystectomy operations.
- Conditions
- Cholecystitis; Gallstone, Mechanical Ventilation Pressure High, Intraabdominal Hypertension
- Being tested
- mechanical ventilation modes
- Keywords
- laparoscopy
- Medical subject headings
- Cholecystitis, Gallstones, Intra-Abdominal Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mechanical ventilation modesDevice
ventilation with pressure controlled mode in laparoscopic abdominal surgery ventilation with volume controlled mode in laparoscopic abdominal surgery
| Study group | Role | What they receive |
|---|---|---|
| v group | Active comparator | patients will ventilate with volume controlled mode Receives: Device: mechanical ventilation modes |
| p group | Active comparator | patients will ventilate with pressure controlled mode Receives: Device: mechanical ventilation modes |
What is being measured
The primary outcome is the main question the study is designed to answer.
NIRS
near infrared reflectance spectroscopy values recorded at before the anesthesia, after intubation, before and after deflation
Measured: 0 to 3 hours (approximately)
oxygen saturation
oxygen saturation with pulse-oximeter at before the anesthesia, after intubation, before and after deflation
Measured: 0 to 3 hours (approximately)
end-tidal carbon dioxide
end-tidal carbon dioxide with mechanical ventilator at before the anesthesia, after intubation, before and after deflation
Measured: 0 to 3 hours (approximately)
Secondary outcomes (2)
partial oxygen pressure
partial oxygen pressure in blood gases at before the anesthesia, after intubation, before and after deflation
Measured: 0 to 3 hours (approximately)
P peak
peak pressure in mechanical ventilation mod at before the anesthesia, after intubation, before and after deflation
Measured: 0 to 3 hours (approximately)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2021
- Study start1 Feb 2021
- Primary completion1 Jun 2021
- Study completion25 Jun 2021
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 Cholecystitis; GallstoneStudies of the same condition, open and under way.
- 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The first group was labelled as "Group V" as they are applied with mechanical ventilation under controlled volume, and the second group was labelled as "Group P" as they are applied with mechanical
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sisli Hamidiye Etfal Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emre Badur MD, Sisli Hamidiye Etfal Training and Research Hospital
- Investigators
- ayse surhan cinar, Study director, chief of anesthesia department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04723043
- Sponsor's protocol ID
- 1305
- Status last verified
- Oct 2021
- First submitted
- 20 Jan 2021
- Last updated
- 14 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gipson CL, Johnson GA, Fisher R, Stewart A, Giles G, Johnson JO, Tobias JD. Changes in cerebral oximetry during peritoneal insufflation for laparoscopic procedures. J Minim Access Surg. 2006 Jun;2(2):67-72. doi: 10.4103/0972-9941.26651.
PubMed 21170237Casati A, Fanelli G, Pietropaoli P, Proietti R, Tufano R, Danelli G, Fierro G, De Cosmo G, Servillo G; Collaborative Italian Study Group on Anesthesia in Elderly Patients. Continuous monitoring of cerebral oxygen saturation in elderly patients undergoing major abdominal surgery minimizes brain exposure to potential hypoxia. Anesth Analg. 2005 Sep;101(3):740-747. doi: 10.1213/01.ane.0000166974.96219.cd.
PubMed 16115985Nielsen HB. Systematic review of near-infrared spectroscopy determined cerebral oxygenation during non-cardiac surgery. Front Physiol. 2014 Mar 17;5:93. doi: 10.3389/fphys.2014.00093. eCollection 2014.
PubMed 24672486
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Pressure Controlled and Volume Controlled Ventilation Modes on Cerebral Oxymetry and Blood Gases In Laparoscopic Cholecystectomy Operations
- ClinicalTrials.gov ID
- NCT04723043
- Acronym / sponsor ID
- 1305
- Conditions
- Cholecystitis; Gallstone, Mechanical Ventilation Pressure High, Intraabdominal Hypertension
- Keywords
- laparoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Sisli Hamidiye Etfal Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 1 Jun 2021 (actual)
- Study completion
- 25 Jun 2021 (actual)
- First posted
- 25 Jan 2021 (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.
In laparoscopic cholecystectomy method, Insufflation of CO2 in abdominal cavity causes positioning of the diaphragm upwards, a decrease in lung's volume and its compliance, an increase in the airway resistance, mismatch between the atelectasis and the ventilation perfusion. Although there are numerous studies in laparoscopic surgery, only a few of them investigate the effects of laparoscopic surgery on the cardiopulmonary and the respiratory mechanics. The investigator aimed To examine the effects of pressure-controlled and volume-controlled ventilation modes on cerebral oximetry and blood gases in laparoscopic cholecystectomy operations.
Detailed description
Since the laparoscopic methods have been introduced to the surgical operations, laparoscopic cholecystectomy has become the golden standard in gall bladder surgical treatments. In this method, carbon dioxide (CO2) pneumoperitoneum method is used to achieve the desired surgical and visual conditions. Alongside the advantages of the Laparoscopic cholecystectomy method (e.g. shortening the patient's length of stay at the hospital, minimal postoperative pain and rapid recovery), it has various intraabdominal pressure related systemic disadvantages . Insufflation of CO2 in abdominal cavity causes positioning of the diaphragm upwards, a decrease in lung's volume and its compliance, an increase in the airway resistance, mismatch between the atelectasis and the ventilation perfusion. Various ventilation strategies have been introduced to increase arterial oxygenation, functional residual capacity (FRC), and the lung compliance. Recent studies; demonstrates that pressure-controlled mechanical ventilation is superior to volume-controlled mechanical ventilation in providing arterial and tissue oxygenation.
Although there are numerous studies in laparoscopic surgery, only a few of them investigate the effects of laparoscopic surgery on the cardiopulmonary and the respiratory mechanics. Several experimental and clinical studies describe that the cardiovascular effects of the high intraabdominal pressure and the CO2 insufflation is complex. In fact, the results are linked to the studied patients' population, the lung's position and its volume. As it is known in laparoscopic surgeries, the oxygenation in cerebral tissue decreases as the intraabdominal pressure increases. At present, bispectral index (BIS), electroencephalography (EEG), auditory evoke potential (AEP) (and several others) and functional NIRS (fNIRS) are used to measure cerebral oxygenation and anaesthetic depth. NIRS monitorisation makes use of the combined effects of the transmission, the reflection, the dispersion, and the absorption of light. It can also measure the oxygen saturation in tissues that does not have pulsatile circulation. The investigator aimed To examine the effects of pressure-controlled and volume-controlled ventilation modes on cerebral oximetry and blood gases in laparoscopic cholecystectomy operations.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The first group was labelled as "Group V" as they are applied with mechanical ventilation under controlled volume, and the second group was labelled as "Group P" as they are applied with mechanical
| Arm | Type | Receives |
|---|---|---|
| v group | Active comparator | Device: mechanical ventilation modespatients will ventilate with volume controlled mode |
| p group | Active comparator | Device: mechanical ventilation modespatients will ventilate with pressure controlled mode |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ASA (American Society of Anesthesiology) score of 1 and 2
- body mass index < 30 kg/m2
- planned elective laparoscopic cholecystectomy operation
- 18-65 years old
Key exclusion criteria (6 listed)
- who are applied with emergency laparoscopic cholecystectomy operation
- ASA (American Society of Anesthesiology) score of 3 and above
- hematocrit value 30 and below
- body mass index> 30 kg/m2
- major pulmonary disease (this condition was defined as having capacity and currency flow speed values that are below %70 in respiratory functional tests)
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 |
|---|---|---|
| mechanical ventilation modesventilation with pressure controlled mode in laparoscopic abdominal surgery ventilation with volume controlled mode in laparoscopic abdominal surgery | Device | p group, v group |
Primary outcome
NIRS
Time frame: 0 to 3 hours (approximately)
near infrared reflectance spectroscopy values recorded at before the anesthesia, after intubation, before and after deflation
oxygen saturation
Time frame: 0 to 3 hours (approximately)
oxygen saturation with pulse-oximeter at before the anesthesia, after intubation, before and after deflation
end-tidal carbon dioxide
Time frame: 0 to 3 hours (approximately)
end-tidal carbon dioxide with mechanical ventilator at before the anesthesia, after intubation, before and after deflation
2 secondary outcomes
partial oxygen pressure
Time frame: 0 to 3 hours (approximately)
P peak
Time frame: 0 to 3 hours (approximately)
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 14 Oct 2021.
- Background: PubMed 21170237Gipson CL, Johnson GA, Fisher R, Stewart A, Giles G, Johnson JO, Tobias JD. Changes in cerebral oximetry during peritoneal insufflation for laparoscopic procedures. J Minim Access Surg. 2006 Jun;2(2):67-72. doi: 10.4103/0972-9941.26651.
- Background: PubMed 16115985Casati A, Fanelli G, Pietropaoli P, Proietti R, Tufano R, Danelli G, Fierro G, De Cosmo G, Servillo G; Collaborative Italian Study Group on Anesthesia in Elderly Patients. Continuous monitoring of cerebral oxygen saturation in elderly patients undergoing major abdominal surgery minimizes brain exposure to potential hypoxia. Anesth Analg. 2005 Sep;101(3):740-747. doi: 10.1213/01.ane.0000166974.96219.cd.
- Background: PubMed 24672486Nielsen HB. Systematic review of near-infrared spectroscopy determined cerebral oxygenation during non-cardiac surgery. Front Physiol. 2014 Mar 17;5:93. doi: 10.3389/fphys.2014.00093. eCollection 2014.
- Individual participant dataSharing planned: No
Related trials for Cholecystitis; Gallstone
Recruiting
Ultrasound-Guided Rectus Sheath Block Versus Local Infiltration
Cholelithiases, Cholecystitis
Recruiting
STALL vs Sole Local Wound Infiltration in Laparoscopic Cholecystectomy
Cholelithiasis, Cholecystitis
Not yet recruiting
Supraglottic Oxygenation Via Oral Transtracheal Catheter for Reducing the Incidence of Hypoxemia During ERCP Under Sedation
Choledocholithiasis With Cholecystitis With Obstruction, Obstructive Jaundice
RecruitingObservational study
Influence of Gut Microbiome in Gallstone Disease
Gall Stone, Gall Stones, Common Bile Duct
Recruiting
Comparison of Gallbladder Extraction Via Subxiphoid vs Infraumbilical Port in Laparoscopic Cholecystectomy
Cholelithiasis (Without Cholecystitis), Cholecystitis, Acute
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.
ayse surhan cinar study director
chief of anesthesia department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mechanical ventilation modes in people with Cholecystitis; Gallstone and Mechanical Ventilation Pressure High, run by Sisli Hamidiye Etfal Training and Research Hospital 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 4 inclusion and 6 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 14 Oct 2021. 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?
NIRS (time frame: 0 to 3 hours (approximately)). The study lists 3 primary outcomes in all. 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 NCT04723043, 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 14 Oct 2021.