Respiratory System AbnormalitiesNCT02439801
Comparison of Effects of PEEP Levels on Respiratory Mechanics in Patients Undergoing Laparoscopic Cholecystectomy
An observational study of Respiratory System Abnormalities, run by Umraniye Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Laparoscopic cholecystectomy is accepted as gold standard in the management of cholelithiasis. Although laparoscopic procedures have many advantages,intra-abdominal CO2 insufflation can cause decreased lung volumes and compliance, increased airway resistance and impaired ventilation-perfusion ratio. Read more about this study
- Who is it for?
- Ages 30 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Respiratory System Abnormalities
- What is being tested?
- PEEP 0, PEEP 5 and PEEP 8
- Type of treatment
- Surgery or procedure
- How many people
- 75 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Mar 2015to May 2015
- How long will I take part?
- 2 Days
- 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 30 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: patients who will undergo for elective laparoscopic cholecystectomy
Who may be able to join
- ASA (American Society of Anesthesiologists) I-II
- BMI of 25-30
- patients scheduled to elective laparoscopic cholecystectomy.
Who cannot join
- Patients with ASA III, IV, V risk,
- Patients with comorbid diseases that may increase intra-abdominal pressure or pulmonary hypertension,
- Patients with renal and hepatic failure,
- Patients with pregnancy and
- Patients using bronchodilator or steroid were excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Effects of 3 Different PEEP Levels on Hemodynamic, Respiratory Mechanics and Elimination of Volatile Anesthetic Agent in Patients Undergoing Laparoscopic Cholecystectomy
Laparoscopic cholecystectomy is accepted as gold standard in the management of cholelithiasis. Although laparoscopic procedures have many advantages,intra-abdominal CO2 insufflation can cause decreased lung volumes and compliance, increased airway resistance and impaired ventilation-perfusion ratio. In this study, investigators aim to investigate effects of intra-operative PEEP treatment at 3 distinct levels on respiratory dynamics and elimination time of volatile anesthetic agent.
Read the detailed description
In the study, 75 ASA I-II patients aged 30-65 years will be randomized into 3 groups to receive 0 cmH2O PEEP (Group-1), 5 cmH2O PEEP (Group-2) and 8 cmH2O PEEP (Group-3) in PVC mode. In all patients underwent general anesthesia; hemodynamic parameters, Ppeak, Pplateau, compliance values as well as Fisevo/Fexpsevo ratio at 1 MAC and times from 1 MAC to 0.3 and 0.1 MAC will be recorded. In addition, preoperative and postoperative pulmonary function tests will be compared in all patients.
- Conditions
- Respiratory System Abnormalities
- Being tested
- PEEP 0, PEEP 5, PEEP 8
- Keywords
- PEEP, compliance, peak airway pressures
- Medical subject headings
- Respiratory System Abnormalities, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEEP 0Procedure or surgery
0 cmH2O positive end expiratory pressure
PEEP 5Procedure or surgery
5 cmH2O positive end expiratory pressure
PEEP 8Procedure or surgery
8 cmH2O positive end expiratory pressure
| Study group | Role | What they receive |
|---|---|---|
| Compliance | Pulmonary compliance (or lung compliance) is a measure of the lung's ability to stretch and expand. In clinical practice it is separated into two different measurements, static compliance and dynamic compliance. Static lung compliance is the change in volume for any given applied pressure. Dynamic lung compliance is the compliance of the lung at any given time during actual movement of air.
Effects of intra-operative PEEP 0, PEEP 5, PEEP 8 treatment on static and dynamic compliance levels will be investigate. Receives: Procedure: PEEP 0; Procedure: PEEP 5; Procedure: PEEP 8 | |
| Pulmonary Function tests | Pulmonary function testing has diagnostic and therapeutic roles and helps clinicians answer some general questions about patients with lung disease.
Effects of intra-operative PEEP 0, PEEP 5, PEEP 8 treatment on pulmonary function test values will be investigate. Receives: Procedure: PEEP 0; Procedure: PEEP 5; Procedure: PEEP 8 | |
| volatil agent elimination time | Volatile anaesthetics are eliminated in the terminal phase via the lungs. A low blood:gas partition coefficient is therefore necessary for quick removal of the anaesthetic.
Effects of intra-operative PEEP 0, PEEP 5, PEEP 8 treatment on volatil agent elimination time will be investigate. Receives: Procedure: PEEP 0; Procedure: PEEP 5; Procedure: PEEP 8 |
What is being measured
The primary outcome is the main question the study is designed to answer.
levels of static-dynamic compliance with intra-operative PEEP treatment at 3 distinct levels
Measured: 1 month
Secondary outcomes (2)
elimination time of volatile anesthetic agent with intra-operative PEEP treatment at 3 distinct levels
Measured: 1 month
levels of p peak and p plateau pressures with intra-operative PEEP treatment at 3 distinct levels
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2015 (estimated)
- Study startMar 2015
- Primary completionMay 2015
- Study completionMay 2015
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 System AbnormalitiesStudies 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
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 75 participants (actual)
- Target duration
- 2 Days
Sponsor and investigators
- Lead sponsor
- Umraniye Education and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Gulsah Karaoren, Umraniye Education and Research Hospital
- Investigators
- Nurten Bakan, MD, Study director, Unraniye training hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02439801
- Sponsor's protocol ID
- GK5
- Status last verified
- May 2015
- First submitted
- 3 May 2015
- Last updated
- 12 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Karsten J, Heinze H, Meier T. Impact of PEEP during laparoscopic surgery on early postoperative ventilation distribution visualized by electrical impedance tomography. Minerva Anestesiol. 2014 Feb;80(2):158-66. Epub 2013 Jul 23.
PubMed 23877309Aydin V, Kabukcu HK, Sahin N, Mesci A, Arici AG, Kahveci G, Ozmete O. Comparison of pressure and volume-controlled ventilation in laparoscopic cholecystectomy operations. Clin Respir J. 2016 May;10(3):342-9. doi: 10.1111/crj.12223. Epub 2014 Nov 14.
PubMed 25307158Ozdilekcan C, Songur N, Berktas BM, Dinc M, Ucgul E, Ok U. Risk factors associated with postoperative pulmonary complications following oncological surgery. Tuberk Toraks. 2004;52(3):248-55.
PubMed 15351938
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Effects of 3 Different PEEP Levels on Hemodynamic, Respiratory Mechanics and Elimination of Volatile Anesthetic Agent in Patients Undergoing Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT02439801
- Acronym / sponsor ID
- GK5
- Conditions
- Respiratory System Abnormalities
- Keywords
- PEEP, compliance, peak airway pressures
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Umraniye Education and Research HospitalOther government
- Study start
- Mar 2015
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 12 May 2015 (estimated)
- 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.
Laparoscopic cholecystectomy is accepted as gold standard in the management of cholelithiasis. Although laparoscopic procedures have many advantages,intra-abdominal CO2 insufflation can cause decreased lung volumes and compliance, increased airway resistance and impaired ventilation-perfusion ratio. In this study, investigators aim to investigate effects of intra-operative PEEP treatment at 3 distinct levels on respiratory dynamics and elimination time of volatile anesthetic agent.
Detailed description
In the study, 75 ASA I-II patients aged 30-65 years will be randomized into 3 groups to receive 0 cmH2O PEEP (Group-1), 5 cmH2O PEEP (Group-2) and 8 cmH2O PEEP (Group-3) in PVC mode. In all patients underwent general anesthesia; hemodynamic parameters, Ppeak, Pplateau, compliance values as well as Fisevo/Fexpsevo ratio at 1 MAC and times from 1 MAC to 0.3 and 0.1 MAC will be recorded. In addition, preoperative and postoperative pulmonary function tests will be compared in all patients.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Target follow-up
- 2 Days
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Compliance | – | Procedure: PEEP 0, Procedure: PEEP 5, Procedure: PEEP 8Pulmonary compliance (or lung compliance) is a measure of the lung's ability to stretch and expand. In clinical practice it is separated into two different measurements, static compliance and dynamic compliance. Static lung compliance is the change in volume for any given applied pressure. Dynamic lung compliance is the compliance of the lung at any given time during actual movement of air. Effects of intra-operative PEEP 0, PEEP 5, PEEP 8 treatment on static and dynamic compliance levels will be investigate. |
| Pulmonary Function tests | – | Procedure: PEEP 0, Procedure: PEEP 5, Procedure: PEEP 8Pulmonary function testing has diagnostic and therapeutic roles and helps clinicians answer some general questions about patients with lung disease. Effects of intra-operative PEEP 0, PEEP 5, PEEP 8 treatment on pulmonary function test values will be investigate. |
| volatil agent elimination time | – | Procedure: PEEP 0, Procedure: PEEP 5, Procedure: PEEP 8Volatile anaesthetics are eliminated in the terminal phase via the lungs. A low blood:gas partition coefficient is therefore necessary for quick removal of the anaesthetic. Effects of intra-operative PEEP 0, PEEP 5, PEEP 8 treatment on volatil agent elimination time will be investigate. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients who will undergo for elective laparoscopic cholecystectomy
Key inclusion criteria (3 listed)
- ASA (American Society of Anesthesiologists) I-II
- BMI of 25-30
- patients scheduled to elective laparoscopic cholecystectomy.
Key exclusion criteria (5 listed)
- Patients with ASA III, IV, V risk,
- Patients with comorbid diseases that may increase intra-abdominal pressure or pulmonary hypertension,
- Patients with renal and hepatic failure,
- Patients with pregnancy and
- Patients using bronchodilator or steroid were excluded.
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 00 cmH2O positive end expiratory pressure | Procedure or surgery | Compliance, Pulmonary Function tests, volatil agent elimination time |
| PEEP 55 cmH2O positive end expiratory pressure | Procedure or surgery | Compliance, Pulmonary Function tests, volatil agent elimination time |
| PEEP 88 cmH2O positive end expiratory pressure | Procedure or surgery | Compliance, Pulmonary Function tests, volatil agent elimination time |
Primary outcome
levels of static-dynamic compliance with intra-operative PEEP treatment at 3 distinct levels
Time frame: 1 month
2 secondary outcomes
elimination time of volatile anesthetic agent with intra-operative PEEP treatment at 3 distinct levels
Time frame: 1 month
levels of p peak and p plateau pressures with intra-operative PEEP treatment at 3 distinct levels
Time frame: 1 month
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 12 May 2015.
- Results publication: PubMed 23877309Karsten J, Heinze H, Meier T. Impact of PEEP during laparoscopic surgery on early postoperative ventilation distribution visualized by electrical impedance tomography. Minerva Anestesiol. 2014 Feb;80(2):158-66. Epub 2013 Jul 23.
- Results publication: PubMed 25307158Aydin V, Kabukcu HK, Sahin N, Mesci A, Arici AG, Kahveci G, Ozmete O. Comparison of pressure and volume-controlled ventilation in laparoscopic cholecystectomy operations. Clin Respir J. 2016 May;10(3):342-9. doi: 10.1111/crj.12223. Epub 2014 Nov 14.
- Results publication: PubMed 15351938Ozdilekcan C, Songur N, Berktas BM, Dinc M, Ucgul E, Ok U. Risk factors associated with postoperative pulmonary complications following oncological surgery. Tuberk Toraks. 2004;52(3):248-55.
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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.
Nurten Bakan, MD study director
Unraniye training hospital
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 Respiratory System Abnormalities, run by Umraniye Education 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 3 inclusion and 5 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 12 May 2015. 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?
levels of static-dynamic compliance with intra-operative PEEP treatment at 3 distinct levels (time frame: 1 month). 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 NCT02439801, 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 12 May 2015.