PneumoperitoneumNCT05367557
Comparison of Intraoperative Hemodynamic Parameters and Arterial-blood Gas Changes at Two Different Pneumoperitoneal Pressure Values
An observational study of Pneumoperitoneum, run by Eva Intagliata at 1 site in Italy.
Trial summary
Clinic and metabolic consequences of pneumoperitoneum, achieved by insufflation of gas carbon dioxide, are still debated. Cardiovascular system suffering due to the compression of intra-abdominal venous structures can cause life-threatening complications. Read more about this study
- Who is it for?
- Ages 15 to 85 years
- Conditions the study is for
- Pneumoperitoneum
- What is being tested?
- laparoscopic cholecystectomy
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jul 2019to 28 Feb 2020
- Phase
- Observational
- 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 15 to 85 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients aged between 15 and 85 years affected by symptomatic cholelithiasis and treated with laparoscopic cholecystectomy
Who may be able to join
- Exclusion Criteria: immunodeficiency disorders, chronic use of corticosteroids, non-compensated diabetes mellitus, major morbidity with a life expectancy of less than 30 days, significant anemia (hemoglobin < 7 gr/Dl or hematocrit < 21%), coagulopathies, ascites, chronic pain treatment, severe comorbidities
- -
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Laparoscopic Surgery: Comparison of Intraoperative Hemodynamic Parameters and Arterial-blood Gas Changes at Two Different Pneumoperitoneal Pressure Values
Clinic and metabolic consequences of pneumoperitoneum, achieved by insufflation of gas carbon dioxide, are still debated. Cardiovascular system suffering due to the compression of intra-abdominal venous structures can cause life-threatening complications. Increased partial pressure of carbon dioxide induces metabolic acidosis with further vascular suffering. Pneumoperitoneum reduces the pulmonary exchange volumes and bring renal suffering.
Methods. The aim of this study is to evaluate the alterations in hemodynamic and hemogasanalysis parameters during the laparoscopic surgery at different pressure settings of pneumoperitoneum in order to assess the best pressure value.
We evaluated and compared intraoperative hemodynamic and hemogasanalytic alterations in two groups of patients respectively subdue to laparoscopic cholecystectomy at a pneumoperitoneum pressure of 12 mmHg (group A) and at a pressure of 8 mmHg (group B).
Read the detailed description
We evaluated intraoperative hemodynamic and hemogasanalytic alterations in two groups of randomized patients respectively operated at a pneumoperitoneum pressure of 12 mmHg (group A) and at a pressure of 8 mmHg (group B) to highlight any significant alterations.
The clinical sample used in the study is composed by patients aged between 15 and 85 years affected by cholelithiasis and treated with laparoscopic cholecystectomy in the period between July 2019 and February 2020.
20 patients, 9 men and 11 women, were enrolled. Group A included 10 patients, 5 men and 5 women, with an average age of 47.9 years. Group B included 10 patients, 4 men and 6 women, with an average age of 50.7 years.
The parameters evaluated were: heart rate (HR), average arterial blood pressure (BP), respiratory frequency (RF), oxygen saturation (SaO2), hemogasanalysis (PaO2, PaCO2, pH and HCO3-).
The measurements were made at four stages: before the induction of anesthesia, after the anesthesia induction but before incision, 30 minutes after the pneumoperitoneum induction, 5 minutes after the pneumoperitoneum releasing.
The hemodynamic parameters (HR, RF, BP, SaO2) were extrapolated from the multiparameter monitor for each evaluation. The hemogasanalytic values (PaO2, PaCO2, pH and HCO3) were evaluated by the radial arterial sampling. The average and standard deviation were calculated for the quantitative data normally distributed. For the comparison of the quantitative data, the t-student test was used. A value of p ≤ 0,05 was considered statistically significant.
- Conditions
- Pneumoperitoneum
- Being tested
- laparoscopic cholecystectomy
- Keywords
- Blood gas analysis alterations; hemodynamic alterations
- Medical subject headings
- Pneumoperitoneum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laparoscopic cholecystectomyProcedure or surgery
removal of the gallbladder by laparoscopy at pneumoperitoneum pressure setting of 12 or 8 mmHg
| Study group | Role | What they receive |
|---|---|---|
| Group A | pneumoperitoneum pressure of 12 mmHg Receives: Procedure: laparoscopic cholecystectomy | |
| Group B | pneumoperitoneum pressure of 8 mmHg Receives: Procedure: laparoscopic cholecystectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
hearth rate
hearth rate variations
Measured: before the induction of anesthesia
hearth rate
hearth rate variations
Measured: after the anesthesia induction but before incision
hearth rate
hearth rate variations
Measured: 30 minutes after the pneumoperitoneum induction
hearth rate
hearth rate variations
Measured: 5 minutes after the pneumoperitoneum releasing
arterial blood pressure
average arterial blood pressure variations
Measured: before the induction of anesthesia
arterial blood pressure
average arterial blood pressure variations
Measured: after the anesthesia induction but before incision
arterial blood pressure
average arterial blood pressure variations
Measured: 30 minutes after the pneumoperitoneum induction
arterial blood pressure
average arterial blood pressure variations
Measured: 5 minutes after the pneumoperitoneum releasing
respiratory frequency
respiratory frequency variations
Measured: before the induction of anesthesia
respiratory frequency
respiratory frequency variations
Measured: after the anesthesia induction but before incision
respiratory frequency
respiratory frequency variations
Measured: 30 minutes after the pneumoperitoneum induction
respiratory frequency
respiratory frequency variations
Measured: 5 minutes after the pneumoperitoneum releasing
oxygen saturation
oxygen saturation variations
Measured: before the induction of anesthesia
oxygen saturation
oxygen saturation variations
Measured: after the anesthesia induction but before incision
oxygen saturation
oxygen saturation variations
Measured: 30 minutes after the pneumoperitoneum induction
oxygen saturation
oxygen saturation variations
Measured: 5 minutes after the pneumoperitoneum releasing
blood gas analysis
blood gas analysis variations
Measured: before the induction of anesthesia
blood gas analysis
blood gas analysis variations
Measured: after the anesthesia induction but before incision
blood gas analysis
blood gas analysis variations
Measured: 30 minutes after the pneumoperitoneum induction
blood gas analysis
blood gas analysis variations
Measured: 5 minutes after the pneumoperitoneum releasing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2022
- Study start1 Jul 2019
- Primary completion1 Feb 2020
- Study completion28 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PneumoperitoneumStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eva Intagliata
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Eva Intagliata, University of Catania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05367557
- Sponsor's protocol ID
- UCatania000
- Status last verified
- May 2022
- First submitted
- 14 Apr 2022
- Last updated
- 10 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Surgery: Comparison of Intraoperative Hemodynamic Parameters and Arterial-blood Gas Changes at Two Different Pneumoperitoneal Pressure Values
- ClinicalTrials.gov ID
- NCT05367557
- Acronym / sponsor ID
- UCatania000
- Conditions
- Pneumoperitoneum
- Keywords
- Blood gas analysis alterations; hemodynamic alterations
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Eva IntagliataUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 1 Feb 2020 (actual)
- Study completion
- 28 Feb 2020 (actual)
- First posted
- 10 May 2022 (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.
Clinic and metabolic consequences of pneumoperitoneum, achieved by insufflation of gas carbon dioxide, are still debated. Cardiovascular system suffering due to the compression of intra-abdominal venous structures can cause life-threatening complications. Increased partial pressure of carbon dioxide induces metabolic acidosis with further vascular suffering. Pneumoperitoneum reduces the pulmonary exchange volumes and bring renal suffering.
Methods. The aim of this study is to evaluate the alterations in hemodynamic and hemogasanalysis parameters during the laparoscopic surgery at different pressure settings of pneumoperitoneum in order to assess the best pressure value.
We evaluated and compared intraoperative hemodynamic and hemogasanalytic alterations in two groups of patients respectively subdue to laparoscopic cholecystectomy at a pneumoperitoneum pressure of 12 mmHg (group A) and at a pressure of 8 mmHg (group B).
Detailed description
We evaluated intraoperative hemodynamic and hemogasanalytic alterations in two groups of randomized patients respectively operated at a pneumoperitoneum pressure of 12 mmHg (group A) and at a pressure of 8 mmHg (group B) to highlight any significant alterations.
The clinical sample used in the study is composed by patients aged between 15 and 85 years affected by cholelithiasis and treated with laparoscopic cholecystectomy in the period between July 2019 and February 2020.
20 patients, 9 men and 11 women, were enrolled. Group A included 10 patients, 5 men and 5 women, with an average age of 47.9 years. Group B included 10 patients, 4 men and 6 women, with an average age of 50.7 years.
The parameters evaluated were: heart rate (HR), average arterial blood pressure (BP), respiratory frequency (RF), oxygen saturation (SaO2), hemogasanalysis (PaO2, PaCO2, pH and HCO3-).
The measurements were made at four stages: before the induction of anesthesia, after the anesthesia induction but before incision, 30 minutes after the pneumoperitoneum induction, 5 minutes after the pneumoperitoneum releasing.
The hemodynamic parameters (HR, RF, BP, SaO2) were extrapolated from the multiparameter monitor for each evaluation. The hemogasanalytic values (PaO2, PaCO2, pH and HCO3) were evaluated by the radial arterial sampling. The average and standard deviation were calculated for the quantitative data normally distributed. For the comparison of the quantitative data, the t-student test was used. A value of p ≤ 0,05 was considered statistically significant.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | – | Procedure: laparoscopic cholecystectomypneumoperitoneum pressure of 12 mmHg |
| Group B | – | Procedure: laparoscopic cholecystectomypneumoperitoneum pressure of 8 mmHg |
Who may qualify
- Ages
- 15 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients aged between 15 and 85 years affected by symptomatic cholelithiasis and treated with laparoscopic cholecystectomy
Key inclusion criteria (2 listed)
- Exclusion Criteria: immunodeficiency disorders, chronic use of corticosteroids, non-compensated diabetes mellitus, major morbidity with a life expectancy of less than 30 days, significant anemia (hemoglobin < 7 gr/Dl or hematocrit < 21%), coagulopathies, ascites, chronic pain treatment, severe comorbidities
- -
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| laparoscopic cholecystectomyremoval of the gallbladder by laparoscopy at pneumoperitoneum pressure setting of 12 or 8 mmHg | Procedure or surgery | Group A, Group B |
Primary outcome
hearth rate
Time frame: before the induction of anesthesia
hearth rate variations
hearth rate
Time frame: after the anesthesia induction but before incision
hearth rate variations
hearth rate
Time frame: 30 minutes after the pneumoperitoneum induction
hearth rate variations
hearth rate
Time frame: 5 minutes after the pneumoperitoneum releasing
hearth rate variations
arterial blood pressure
Time frame: before the induction of anesthesia
average arterial blood pressure variations
arterial blood pressure
Time frame: after the anesthesia induction but before incision
average arterial blood pressure variations
arterial blood pressure
Time frame: 30 minutes after the pneumoperitoneum induction
average arterial blood pressure variations
arterial blood pressure
Time frame: 5 minutes after the pneumoperitoneum releasing
average arterial blood pressure variations
respiratory frequency
Time frame: before the induction of anesthesia
respiratory frequency variations
respiratory frequency
Time frame: after the anesthesia induction but before incision
respiratory frequency variations
respiratory frequency
Time frame: 30 minutes after the pneumoperitoneum induction
respiratory frequency variations
respiratory frequency
Time frame: 5 minutes after the pneumoperitoneum releasing
respiratory frequency variations
oxygen saturation
Time frame: before the induction of anesthesia
oxygen saturation variations
oxygen saturation
Time frame: after the anesthesia induction but before incision
oxygen saturation variations
oxygen saturation
Time frame: 30 minutes after the pneumoperitoneum induction
oxygen saturation variations
oxygen saturation
Time frame: 5 minutes after the pneumoperitoneum releasing
oxygen saturation variations
blood gas analysis
Time frame: before the induction of anesthesia
blood gas analysis variations
blood gas analysis
Time frame: after the anesthesia induction but before incision
blood gas analysis variations
blood gas analysis
Time frame: 30 minutes after the pneumoperitoneum induction
blood gas analysis variations
blood gas analysis
Time frame: 5 minutes after the pneumoperitoneum releasing
blood gas analysis variations
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 10 May 2022.
- Individual participant dataSharing planned: No
Related trials for Pneumoperitoneum
Not yet recruitingPhase 4
Effect of Prophylactic Dexamethasone vs Placebo on Airway Dimensions Assessed by Ultrasonography in Patients Undergoing Laparoscopic Cholecystectomy
Airway Edema, Postoperative Complications
Not yet recruitingObservational study
Fluid Responsiveness in Laparoscopic Surgery: End-Expiratory Occlusion Test Versus Mini-Fluid Challenge
Fluid Responsiveness, Laparoscopic Surgery
Recruiting
Low Pneumoperitoneum Pressure for Delirium Prevention in Elderly Laparoscopy
Postoperative Delirium (POD), Intracranial Hypertension
Active, not recruiting
Comparison of the Efficacy of Different Analgesic Strategies for Pain Control After Laparoscopic Cholecystectomy (LC)
Gallstones, Pain
Not yet recruitingObservational study
Effects of Trendelenburg Position and Pneumoperitoneum on Mechanical Power and Respiratory Mechanics During V-NOTES Surgery
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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?
An observational study of Pneumoperitoneum, run by Eva Intagliata at 1 site in Italy.
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 0 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 10 May 2022. 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 Italy. 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?
hearth rate (time frame: before the induction of anesthesia). The study lists 20 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 May 2022.