Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03704038
Other study ID # 2018EIT
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 1, 2018
Est. completion date November 1, 2018

Study information

Verified date April 2019
Source University Hospital Dubrava
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Goal of this study is to determine optimal PEEP levels for patients undergoing surgery in lateral decubitus position. Patients will be randomized into 3 groups - PEEP 0, 5 and 10 mbar. Endotracheal anesthesia will be conducted with propofol, fentanyl, rocuronium and sevoflurane/O2/air gas mixture.

Patients with preexisting lung disease, organ transplants and disseminated malignant disease will be excluded.

Demographic data - age, weight, height, ASA status, smoking history will be recorded. EIT measured parameters - tidal variation ratio of nondependent and dependent lung, regional end-tidal and end-expiratory lung impedances as well as horizontal and vertical centers of ventilation will be recorded and calculated at 3 time points - before anesthesia induction, 5 minutes after lateral positioning of the patient and 90 minutes after lateral positioning. ABGs will be sampled to calculate aA gradient and Horovitz quotient at those time points as well as measured hemodynamic parameters (HR, BP, CI, SVI).

Primary endpoints for the study are nondependent/dependent tidal variation ratios measured at predefined time points and changes in ABGs. Secondary endpoints are number of postoperative pulmonary complications (defined as new onset of pneumonia during 28 days of followup), length of hospital stay and changes in hemodynamic parameters.


Recruitment information / eligibility

Status Completed
Enrollment 33
Est. completion date November 1, 2018
Est. primary completion date November 1, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- patients scheduled for nephrectomy, adrenalectomy or urterotomy surgery which will be performed in lateral decubitus position

- signed informed consent form

Exclusion Criteria:

- preexisting moderate to severe obstructive (GOLD score > 1) or restrictive lung disease (FVC < 85%)

- history of organ transplant

- disseminated malignant disease

- pregnancy

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
PEEP level
Patients will have variable PEEP levels and will be monitored

Locations

Country Name City State
Croatia University Hospital Dubrava Zagreb Grad Zagreb

Sponsors (1)

Lead Sponsor Collaborator
University Hospital Dubrava

Country where clinical trial is conducted

Croatia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change of nondependent / dependent tidal variation Measured by EIT Baseline, 10 and 90 minutes post lateral positioning
Secondary Change of a-A gradient Measured by ABG analysis Baseline, 10 and 90 minutes post lateral positioning
Secondary Duration of hospital stay Between groups Up to 28 days
See also
  Status Clinical Trial Phase
Completed NCT05921656 - Construction and Evaluation of Airway Leakage Risk Model of Patients With Endotracheal Tube
Recruiting NCT03941002 - Continuous Evaluation of Diaphragm Function N/A
Withdrawn NCT04288076 - The Brain and Lung Interaction (BALI) Study N/A
Completed NCT03031860 - Semi-quantitative Cough Strength Score (SCSS) N/A
Completed NCT02312869 - Local Assessment of Management of Burn Patients N/A
Completed NCT02545621 - A Role for RAGE/TXNIP/Inflammasome Axis in Alveolar Macrophage Activation During ARDS (RIAMA): a Proof-of-concept Clinical Study
Completed NCT01885442 - TryCYCLE: A Pilot Study of Early In-bed Leg Cycle Ergometry in Mechanically Ventilated Patients N/A
Completed NCT01204281 - Proportional Assist Ventilation (PAV) in Early Stage of Critically Ill Patients Phase 4
Terminated NCT01059929 - Dexmedetomidine Versus Propofol in the Medical Intensive Care Unit (MICU) Phase 4
Completed NCT00824239 - Intermittent Sedation Versus Daily Interruption of Sedation in Mechanically Ventilated Patients Phase 3
Completed NCT00529347 - Mechanical Ventilation Controlled by the Electrical Activity of the Patient's Diaphragm - Effects of Changes in Ventilator Parameters on Breathing Pattern Phase 1
Unknown status NCT00260676 - Protective Ventilatory Strategy in Potential Organ Donors Phase 3
Terminated NCT00205517 - Sedation and Psychopharmacology in Critical Care N/A
Completed NCT03281785 - Ultrasound of Diaphragmatic Musculature in Mechanically Ventilated Patients. N/A
Recruiting NCT04110613 - RCT: Early Feeding After PEG Placement N/A
Completed NCT04410783 - The Emergency Department Sedation Pilot Trial N/A
Recruiting NCT04821453 - NAVA vs. CMV Crossover in Severe BPD N/A
Completed NCT03930147 - Ventilation With ASV Mode in Children N/A
Recruiting NCT05029167 - REstrictive Versus LIberal Oxygen Strategy and Its Effect on Pulmonary Hypertension After Out-of-hospital Cardiac Arrest (RELIEPH-study) N/A
Recruiting NCT04849039 - Lung Microbiota and VAP Development (PULMIVAP)