Mechanical Ventilation Based on Driving Pressure in Lateral Position

NCT04455789 | Suspended

• 1 other identifier: AkdenizU-2
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Fracture of Hip; Osteoarthritis, Hip; Congenital Hip Deformity

Keywords

Driving Pressure; lung protective ventilation; PEEP; total hip replacement; lateral position

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• postoperative mechanical ventilation duration

  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

  From end of operation to the end of intensive care stay, up to 1 week

• length of hospital stay after the operation

  form end of surgery to the end of hospital stay, up to 10 days

Study Arms (2)

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

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

Procedure: routine lung protective, conventional mechanical ventilation

Interventions

routine lung protective, conventional mechanical ventilation PROCEDURE

routine lung protective, conventional mechanical ventilation with stabil PEEP

Also known as: routine lung protective, conventional mechanical ventilation with PEEP adjusted to the lowest Driving Pressure level

conventional mechanical ventilation; mechanical ventilation adjusted according to driving pressure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients planned to have total hip replacement

You may not qualify if:

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

Sponsors & Collaborators

• Akdeniz University: lead

Study Sites (1)

Akdeniz University Hospital

Antalya, 07070, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hip Fractures; Osteoarthritis, Hip

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries; Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Study Record Dates

• First Submitted: June 25, 2020
• First Posted: July 2, 2020
• Study Start: August 1, 2019
• Primary Completion: August 1, 2022
• Study Completion: August 1, 2024
• Last Updated: January 31, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)