Mechanical Ventilation Based on Driving Pressure in Lateral Position

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.

Study Overview

• Status: Suspended
• Conditions: Osteoarthritis, Hip; Fracture of Hip; Congenital Hip Deformity
• Intervention / Treatment: Procedure: routine lung protective, conventional mechanical ventilation

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 Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Antalya, Turkey, 07070
    • Akdeniz University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Patients planned to have total hip replacement

Exclusion Criteria:

High intracranial pressure Bronchopleural fistula Hypovolemic shock Right ventricular failure Left ventricular failure(Ejection fraction lower than 50%) Arrythmia

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: conventional mechanical ventilation; routine mechanical ventilation will be adjusted based on conventional mechanical ventilation settings with tidal volume of 8 ml/kg and PEEP level of 5	Procedure: routine lung protective, conventional mechanical ventilation; routine lung protective, conventional mechanical ventilation with stabil PEEP; Other Names: routine lung protective, conventional mechanical ventilation with PEEP adjusted to the lowest Driving Pressure level
Experimental: mechanical ventilation adjusted according to driving pressure; 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	Procedure: routine lung protective, conventional mechanical ventilation; routine lung protective, conventional mechanical ventilation with stabil PEEP; Other Names: routine lung protective, conventional mechanical ventilation with PEEP adjusted to the lowest Driving Pressure level

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
volume of intraoperative fluid administration	the patients will receive intraoperative fluids according to a protocol based on PVI.	during intraoperative period
intraoperative etCO2 levels	et CO2 levels will be recorded form the anesthesia machine monitor	during mechanical ventilation
lactate levels	lactate levels will be obtained from the serial blood gas analysis	during intraoperative period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative mechanical ventilation duration	The patient's need for mechanical ventilation, after the surgery, will be assessed	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	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	form end of surgery to the end of hospital stay, up to 10 days

Collaborators and Investigators

• Sponsor: Akdeniz University
• Investigators: Principal Investigator: Zekiye Bigat, Prof, Akdeniz University Medical School Anesthesiology and Reanimation Department; Principal Investigator: İlker O Aycan, Ass Prof, Akdeniz University Medical school Anesthesiology and Reanimation Departmnet

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2019
• Primary Completion (Actual): August 1, 2022
• Study Completion (Estimated): August 1, 2024

Study Registration Dates

• First Submitted: June 25, 2020
• First Submitted That Met QC Criteria: July 1, 2020
• First Posted (Actual): July 2, 2020

Study Record Updates

• Last Update Posted (Actual): January 31, 2024
• Last Update Submitted That Met QC Criteria: January 30, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: total hip replacement; lung protective ventilation; PEEP; Driving Pressure; lateral position
• Additional Relevant MeSH Terms: Fractures, Bone; Wounds and Injuries; Leg Injuries; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Femoral Fractures; Hip Injuries; Osteoarthritis; Hip Fractures; Osteoarthritis, Hip
• Other Study ID Numbers: AkdenizU-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No