- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03514706
Effect of PCV and VCV on Extravascular Lung Water
The Ultrasound Estimation of Extravascular Lung Water in Volume Controlled Versus Pressure Controlled Ventilation After One Lung Ventilation in Thoracoscopic Surgery. A Comparative Study
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Cairo, Egypt, 11516
- Kasr Al-Ainy faculty of medicine. Cairo University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Adult patients aged (18-60 years), undergoing elective thoracoscopic surgery with one lung ventilation
Exclusion Criteria:
- Emergency surgeries.
- Left Ventricular ejection fraction less than 40%.
- Any patient known to have pulmonary hypertension
- Patients with preoperative congestive heart failure, cardiogenic shock, preoperative pulmonary edema
- Hepatic patients (liver functions double the upper reference range)
- Morbid obesity (BMI > 40).
- Renally impaired patients with creatinine more than 2 mg/dl.
- Any patient with respiratory dysfunction (FEV1<60% of the expected).
- Any patient with previous thoracic surgery.
- One lung ventilation more than 2 hours
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Volume controlled ventilation
Group V: Patients will receive volume controlled mechanical ventilation.
(Vt 7ml/kg ideal body weight).
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Lung ultrasound (LUS) will be performed with a 2-4 MHz phased array probe. Patients will be scanned in supine position by a recording 5 seconds videos. LUS will be assessed for the presence of B lines. The sum of lung comets produces a score reflecting the extent of lung water accumulation. LUS will be obtained by scanning 12-rib interspaces. The sum of B-lines on each scanning site yields a score from 0 to 36
Other Names:
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Experimental: Pressure controlled ventilation
Group P: Patients will receive pressure controlled mechanical ventilation.
(to achieve Vt 7 ml/kg ideal body weight, Pmax 30 cmH2O)
|
Lung ultrasound (LUS) will be performed with a 2-4 MHz phased array probe. Patients will be scanned in supine position by a recording 5 seconds videos. LUS will be assessed for the presence of B lines. The sum of lung comets produces a score reflecting the extent of lung water accumulation. LUS will be obtained by scanning 12-rib interspaces. The sum of B-lines on each scanning site yields a score from 0 to 36
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Lung ultrasound score
Time Frame: change of lung ultrasound scores introperatively during double lung and single lung ventilation and after 2 hours postoperatively compared to baseline scores before anesthesia induction
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The sum of B lines reflects the extent of lung water accumulation.
The lung ultrasound score(LUS) will be obtained by scanning 12-rib interspaces.
The dependent lung will be divided into six areas: two anterior areas, two lateral areas, and two posterior areas.
The anterior chest wall (zone 1) will be delineated from the parasternal to the anterior axillary line and will be divided into upper and lower halves, from the clavicle to the third intercostal space and from the third to the diaphragm.
The lateral area (zone 2) will be delineated from the anterior to the posterior axillary line and was divided into upper and basal halves.
The posterior area (zone 3) will be considered as the zone beyond the posterior axillary line.
The sum of B-lines on each scanning site (0: absence; 1: B7 lines: multiple B-lines 7 mm apart; 2: B3 lines: multiple B 3 mm apart; 3: consolidation) yields a score from 0 to 36(10) score for the ventilated lung is only from 0-18.
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change of lung ultrasound scores introperatively during double lung and single lung ventilation and after 2 hours postoperatively compared to baseline scores before anesthesia induction
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Hisham Hosny, MD, Kasr Al-Ainy Faculty of Medicine
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- AnesthN-8-2018
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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