Fracture of HipNCT04455789
Mechanical Ventilation Based on Driving Pressure in Lateral Position
A study testing routine lung protective, conventional mechanical ventilation in people with Fracture of Hip and Osteoarthritis, Hip, run by Akdeniz University at 1 site in Turkey (Türkiye).
Trial summary
Previous studies showed that, best lung protective strategies of ventilation parameters are based on driving pressure in damaged lungs. But there are few studies concerning the effects of different positions during different types of surgery on driving pressure with normal lungs.So the investigators decided to compare… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fracture of Hip, Osteoarthritis, Hip, Congenital Hip Deformity
- What is being tested?
- routine lung protective, conventional mechanical ventilation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2019to 1 Aug 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients planned to have total hip replacement
Who cannot join
- High intracranial pressure Bronchopleural fistula Hypovolemic shock Right ventricular failure Left ventricular failure(Ejection fraction lower than 50%) Arrythmia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mechanical Ventilation in Lateral Position During Total Hip Replacement Surgery : Comparison of Driving Pressure With Conventional Ventilation
Previous studies showed that, best lung protective strategies of ventilation parameters are based on driving pressure in damaged lungs. But there are few studies concerning the effects of different positions during different types of surgery on driving pressure with normal lungs.So the investigators decided to compare mechanical ventilation based on driving pressure with conventional mechanical ventilation in patients with lateral decubitus position during total hip replacement surgery. The investigators hypothesised that, there will be better intraoperative hemodynamic and respiratory parameters with better early postoperative results in patients whom mechanical ventilation parameters are adjusted according to driving pressure.
In this randomised, controlled, double blind study, 60 patients who will have total hip replacement surgery will be recruited to the study. 30 patients will be ventilated by 8 ml/kg tidal volume and 5 cmH20 PEEP, in conventional lung protective group. And the other 30 patients will be ventilated by 8 ml/kg tidal volume and PEEP level with the lowest driving pressure.
The investigators primary goal in this study study is to compare the effects of conventional lung protective ventilation with ventilation based on driving pressure on hemodynamic and respiratory parameters. And secondly, the investigators aim to compare the effects of these two techniques s on early postoperative outcome. The investigators primary result parameters are intra operative fluid consumption, lactate, etC02 and mix venous oxygen saturation levels.The investigators secondary result parameters are postoperative mechanical ventilation, ICU stay and discharge times.
Read the detailed description
There may be physiologic and pathologic pulmonary changes because of inflammatory cytokine release during total hip replacement surgery due to surgical invasivity or advanced age, comorbidities, perioperative immobility of patients. Also intraoperative mechanical ventilation can cause volutrauma, barotrauma or atelectrauma risk because of lateral position during hip replacement surgery. All these factors can cause pulmonary complications and vascular permeability increase in dependent and independent regions due to neutrophil response increase. Intraoperative hypovolemia is often observed in this group patients because of preoperative prolonged fasting periods, insufficient fluid intake due to preoperative delirium and depression. Also mechanical ventilation with positive pressure slightly decreases venous return to the heart resulting decrease in cardiac output. It is more obvious in the presence of hypovolemia. Providing continuous sufficient intravascular volume is necessary for prevention of tissue hypoxia and providing optimal cardiac output. It is known that intra operative hemodynamic optimisation, has positive effects on mortality ratio. But proper intravascular volume is not always easy to maintain, and it is not always easy for anaesthetists to identify deficiency or overload of intra operative intravascular volume. In recent years, intravascular volume therapies are goal directed by the reflections of respiratory mechanics on arterial pressure and pulse oximetry. Plethysmographic wave changes observed in pulse oximetry induced by positive pressure ventilation is accepted as indicator of hypovolemia. Hemodynamic changes induced by respiratory mode can be measured by invasive arterial monitorization. This dynamic variable is called as pulse pressure variation index and is correlated with amplitude changes observed in pulse oximetry signals. These variations are based on changes observed in pulse wavelength due to the changes in intrathoracic pressure. In some pulse oximetry devices, this is done as standard function as path variability index (PVI). PVI is measurement of dynamic changes of perfusion index during a whole respiratory cycle. Pulse oximetry wave length changes enables the evaluate hypovolemia noninvasively.
PVI is gaining importance as a dynamic parameter in evaluating fluid treatment during surgery. Goal directed fluid therapy has shown positive effects on results on patient survival. In a study which fluid therapy was guided by PVI changes and it was reported that, goal directed fluid therapy had positive results.The investigators also, use some invasive and noninvasive monitorization techniques, including PVI and CVP, to monitor static and dynamic hemodynamic parameters during hip replacement surgery and we apply fluids according to our fluid therapy protocols. The investigators use blood gas analysis to monitor the efficiency of this treatment.
In this study, in both groups the investigators will apply fluid according to PVI values, so if any difference detected is observed between groups will be because of the differences of respiratory parameters between groups. And the investigators can detect, PVI stability and less fluid needs differences between groups.
PETCO2 is, another parameter which will be evaluated in this study, is a factor of tissue CO2 production (VCO2), alveolar ventilation and cardiac output (mainly pulmonary blood flow). It is known that, when CO2 produced at the tissues and formed in lungs are constant, the changes of etCO2 are due to the blood flow differences and it is related to changes of cardiac output. For this reason, PETCO2 is suggested as a noninvasive measure for continuous assessment of cardiac output. At the same time, it is possible to comment about changes of dead space by measuring arterial CO2 pressure.
Decrease of PETCO2, resulted from cardiac output decrease, can not be explained only with the decrease rate of excretion of CO2, but also can be explained by the changes of production of CO2 caused by dependency to oxygen supply. On the contrary, when cardiac output is high, pulmonary blood flow is no longer a limiting factor for PETCO2 formation, and PETCO2 is related to sufficiency of alveolar ventilation.
As a result, etCO2 measurement has some advantages; it is simple noninvasive and does not require a invasive hemodynamic measurement.
- Being tested
- routine lung protective, conventional mechanical ventilation
- Keywords
- Driving Pressure, lung protective ventilation, PEEP, total hip replacement, lateral position
- Medical subject headings
- Hip Fractures, Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
routine lung protective, conventional mechanical ventilationProcedure or surgery
Also called routine lung protective, conventional mechanical ventilation with PEEP adjusted to the lowest Driving Pressure level
routine lung protective, conventional mechanical ventilation with stabil PEEP
| Study group | Role | What they receive |
|---|---|---|
| conventional mechanical ventilation | Experimental | routine mechanical ventilation will be adjusted based on conventional mechanical ventilation settings with tidal volume of 8 ml/kg and PEEP level of 5 Receives: Procedure: routine lung protective, conventional mechanical ventilation |
| mechanical ventilation adjusted according to driving pressure | Experimental | routine mechanical ventilation adjusted based on driving pressure during lateral position. After patients are put to lateral position incremental increase in PEEP will be applied and the driving pressures will be recorded for each PEEP level and the patients will be ventilated with this PEEP during anesthesia. the other setting will be same with conventional group. tidal volume of 8 ml/kg Receives: Procedure: routine lung protective, conventional mechanical ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
volume of intraoperative fluid administration
the patients will receive intraoperative fluids according to a protocol based on PVI.
Measured: during intraoperative period
intraoperative etCO2 levels
et CO2 levels will be recorded form the anesthesia machine monitor
Measured: during mechanical ventilation
lactate levels
lactate levels will be obtained from the serial blood gas analysis
Measured: during intraoperative period
Secondary outcomes (3)
postoperative mechanical ventilation duration
The patient's need for mechanical ventilation, after the surgery, will be assessed
Measured: From end of surgery to the end of mechanical ventilation duration in the intensive care unit until the patient is extubated, up to 3 days
postoperative intensive care stay
after the end of surgery the patients need for intensive care will be assessed
Measured: From end of operation to the end of intensive care stay, up to 1 week
length of hospital stay after the operation
the effects of mechanical ventilation on the days of hospital stay will be assessed
Measured: form end of surgery to the end of hospital stay, up to 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2020
- Study start1 Aug 2019
- Primary completion1 Aug 2022
- Study completion1 Aug 2024 (estimated)
Why it stopped: monitoring equipment used in the study is not available
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fracture of HipStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Akdeniz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nesil Coskunfirat, Akdeniz University
- Investigators
- Zekiye Bigat, Prof, Principal investigator, Akdeniz University Medical School Anesthesiology and Reanimation Departmentİlker O Aycan, Ass Prof, Principal investigator, Akdeniz University Medical school Anesthesiology and Reanimation Departmnet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04455789
- Sponsor's protocol ID
- AkdenizU-2
- Status last verified
- Jan 2024
- First submitted
- 25 Jun 2020
- Last updated
- 31 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanical Ventilation in Lateral Position During Total Hip Replacement Surgery : Comparison of Driving Pressure With Conventional Ventilation
- ClinicalTrials.gov ID
- NCT04455789
- Acronym / sponsor ID
- AkdenizU-2
- Keywords
- Driving Pressure, lung protective ventilation, PEEP, total hip replacement, lateral position
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: monitoring equipment used in the study is not available
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 1 Aug 2022 (actual)
- Study completion
- 1 Aug 2024 (estimated)
- First posted
- 2 Jul 2020 (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.
Previous studies showed that, best lung protective strategies of ventilation parameters are based on driving pressure in damaged lungs. But there are few studies concerning the effects of different positions during different types of surgery on driving pressure with normal lungs.So the investigators decided to compare mechanical ventilation based on driving pressure with conventional mechanical ventilation in patients with lateral decubitus position during total hip replacement surgery. The investigators hypothesised that, there will be better intraoperative hemodynamic and respiratory parameters with better early postoperative results in patients whom mechanical ventilation parameters are adjusted according to driving pressure.
In this randomised, controlled, double blind study, 60 patients who will have total hip replacement surgery will be recruited to the study. 30 patients will be ventilated by 8 ml/kg tidal volume and 5 cmH20 PEEP, in conventional lung protective group. And the other 30 patients will be ventilated by 8 ml/kg tidal volume and PEEP level with the lowest driving pressure.
The investigators primary goal in this study study is to compare the effects of conventional lung protective ventilation with ventilation based on driving pressure on hemodynamic and respiratory parameters. And secondly, the investigators aim to compare the effects of these two techniques s on early postoperative outcome. The investigators primary result parameters are intra operative fluid consumption, lactate, etC02 and mix venous oxygen saturation levels.The investigators secondary result parameters are postoperative mechanical ventilation, ICU stay and discharge times.
Detailed description
There may be physiologic and pathologic pulmonary changes because of inflammatory cytokine release during total hip replacement surgery due to surgical invasivity or advanced age, comorbidities, perioperative immobility of patients. Also intraoperative mechanical ventilation can cause volutrauma, barotrauma or atelectrauma risk because of lateral position during hip replacement surgery. All these factors can cause pulmonary complications and vascular permeability increase in dependent and independent regions due to neutrophil response increase. Intraoperative hypovolemia is often observed in this group patients because of preoperative prolonged fasting periods, insufficient fluid intake due to preoperative delirium and depression. Also mechanical ventilation with positive pressure slightly decreases venous return to the heart resulting decrease in cardiac output. It is more obvious in the presence of hypovolemia. Providing continuous sufficient intravascular volume is necessary for prevention of tissue hypoxia and providing optimal cardiac output. It is known that intra operative hemodynamic optimisation, has positive effects on mortality ratio. But proper intravascular volume is not always easy to maintain, and it is not always easy for anaesthetists to identify deficiency or overload of intra operative intravascular volume. In recent years, intravascular volume therapies are goal directed by the reflections of respiratory mechanics on arterial pressure and pulse oximetry. Plethysmographic wave changes observed in pulse oximetry induced by positive pressure ventilation is accepted as indicator of hypovolemia. Hemodynamic changes induced by respiratory mode can be measured by invasive arterial monitorization. This dynamic variable is called as pulse pressure variation index and is correlated with amplitude changes observed in pulse oximetry signals. These variations are based on changes observed in pulse wavelength due to the changes in intrathoracic pressure. In some pulse oximetry devices, this is done as standard function as path variability index (PVI). PVI is measurement of dynamic changes of perfusion index during a whole respiratory cycle. Pulse oximetry wave length changes enables the evaluate hypovolemia noninvasively.
PVI is gaining importance as a dynamic parameter in evaluating fluid treatment during surgery. Goal directed fluid therapy has shown positive effects on results on patient survival. In a study which fluid therapy was guided by PVI changes and it was reported that, goal directed fluid therapy had positive results.The investigators also, use some invasive and noninvasive monitorization techniques, including PVI and CVP, to monitor static and dynamic hemodynamic parameters during hip replacement surgery and we apply fluids according to our fluid therapy protocols. The investigators use blood gas analysis to monitor the efficiency of this treatment.
In this study, in both groups the investigators will apply fluid according to PVI values, so if any difference detected is observed between groups will be because of the differences of respiratory parameters between groups. And the investigators can detect, PVI stability and less fluid needs differences between groups.
PETCO2 is, another parameter which will be evaluated in this study, is a factor of tissue CO2 production (VCO2), alveolar ventilation and cardiac output (mainly pulmonary blood flow). It is known that, when CO2 produced at the tissues and formed in lungs are constant, the changes of etCO2 are due to the blood flow differences and it is related to changes of cardiac output. For this reason, PETCO2 is suggested as a noninvasive measure for continuous assessment of cardiac output. At the same time, it is possible to comment about changes of dead space by measuring arterial CO2 pressure.
Decrease of PETCO2, resulted from cardiac output decrease, can not be explained only with the decrease rate of excretion of CO2, but also can be explained by the changes of production of CO2 caused by dependency to oxygen supply. On the contrary, when cardiac output is high, pulmonary blood flow is no longer a limiting factor for PETCO2 formation, and PETCO2 is related to sufficiency of alveolar ventilation.
As a result, etCO2 measurement has some advantages; it is simple noninvasive and does not require a invasive hemodynamic measurement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conventional mechanical ventilation | Experimental | Procedure: routine lung protective, conventional mechanical ventilationroutine mechanical ventilation will be adjusted based on conventional mechanical ventilation settings with tidal volume of 8 ml/kg and PEEP level of 5 |
| mechanical ventilation adjusted according to driving pressure | Experimental | Procedure: routine lung protective, conventional mechanical ventilationroutine mechanical ventilation adjusted based on driving pressure during lateral position. After patients are put to lateral position incremental increase in PEEP will be applied and the driving pressures will be recorded for each PEEP level and the patients will be ventilated with this PEEP during anesthesia. the other setting will be same with conventional group. tidal volume of 8 ml/kg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients planned to have total hip replacement
Key exclusion criteria (1 listed)
- High intracranial pressure Bronchopleural fistula Hypovolemic shock Right ventricular failure Left ventricular failure(Ejection fraction lower than 50%) Arrythmia
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 |
|---|---|---|
| routine lung protective, conventional mechanical ventilationAlso: routine lung protective, conventional mechanical ventilation with PEEP adjusted to the lowest Driving Pressure levelroutine lung protective, conventional mechanical ventilation with stabil PEEP | Procedure or surgery | conventional mechanical ventilation, mechanical ventilation adjusted according to driving pressure |
Primary outcome
volume of intraoperative fluid administration
Time frame: during intraoperative period
the patients will receive intraoperative fluids according to a protocol based on PVI.
intraoperative etCO2 levels
Time frame: during mechanical ventilation
et CO2 levels will be recorded form the anesthesia machine monitor
lactate levels
Time frame: during intraoperative period
lactate levels will be obtained from the serial blood gas analysis
3 secondary outcomes
postoperative mechanical ventilation duration
Time frame: From end of surgery to the end of mechanical ventilation duration in the intensive care unit until the patient is extubated, up to 3 days
postoperative intensive care stay
Time frame: From end of operation to the end of intensive care stay, up to 1 week
length of hospital stay after the operation
Time frame: form end of surgery to the end of hospital stay, up to 10 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2024.
- 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.
Zekiye Bigat, Prof principal investigator
Akdeniz University Medical School Anesthesiology and Reanimation Department
İlker O Aycan, Ass Prof principal investigator
Akdeniz University Medical school Anesthesiology and Reanimation Departmnet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing routine lung protective, conventional mechanical ventilation in people with Fracture of Hip and Osteoarthritis, Hip, run by Akdeniz University 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 1 inclusion and 1 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: paused, as of the sponsor's last update on 31 Jan 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?
Results are not available in the source record.
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?
volume of intraoperative fluid administration (time frame: during intraoperative period). 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?
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 31 Jan 2024.