- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06654778
Ultrasound Evaluation of Preventive Measures for Postoperative Lung Atelectasis After Surgery (LUS/PEEP/RM)
Ultrasound Evaluation of Different Preventive Measures of Post Operative Lung Atelectasis After Upper Abdominal Surgeries: Ventilation and Fluid Measures
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Asyut, Egypt
- Al-Azhar University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- ASA physical status I or II, of either gender.
- BMI < 40
- Age 30-60 years
- scheduled for elective abdominal surgeries
Exclusion Criteria:
- Patient refusal
- American Society of Anesthesiologists (ASA) physical status classification system more than II
- BMI > 40 .
- Psychiatric disorders
- History of chest disorders such as asthma and obstructive pulmonary disease (COPD).
- History of Previous Thoracic Procedures.
- Pregnancy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group I: PEEP
Patients will be ventilated with PEEP of 8 cm H2O and fluid management: 500 ml of Ringer's lactate in the recovery room before surgery and Ringer's lactate at a rate of 4 mL/kg/hour from the beginning to the end of the surgery.
|
Patients will be ventilated with PEEP of 8 cm H2O and fluid management: 500 ml of Ringer's lactate in the recovery room before surgery and Ringer's lactate at a rate of 4 mL/kg/hour from the beginning to the end of the surgery.
|
|
Experimental: Group II: PEEP/RM
Patients will be ventilated with PEEP of 8 cm H2O, and then RM (30 cm H2O for 30 s) will be applied immediately after the second LUS examination and repeated every 30 minutes till emergence and fluid management: 500 ml of Ringer's lactate in recovery room before surgery and Ringer's lactate at a rate of 4 mL/kg/hour from the beginning to the end of the surgery
|
Patients will be ventilated with PEEP of 8 cm H2O, and then RM (30 cm H2O for 30 s) will be applied immediately after the second LUS examination and repeated every 30 minutes till emergence and fluid management: 500 ml of Ringer's lactate in recovery room before surgery and Ringer's lactate at a rate of 4 mL/kg/hour from the beginning to the end of the surgery
|
|
Experimental: Group III: PEEP/RM/RF
Patients will be ventilated with PEEP of 8 cm H2O, and then RM (30 cm H2O for 30 s) will be applied immediately after the second LUS examination and repeated every 30 minutes till emergence and restrictive fluid management (RF).
Ringer's lactate at a rate of 3 mL/kg/hour from the beginning to the end of the surgery
|
Patients will be ventilated with PEEP of 8 cm H2O, and then RM (30 cm H2O for 30 s) will be applied immediately after the second LUS examination and repeated every 30 minutes till emergence and restrictive fluid management (RF).
Ringer's lactate at a rate of 3 mL/kg/hour from the beginning to the end of the surgery
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Lung ultrasound assessment of postoperative pulmonary atelectasis at the end of surgery
Time Frame: at the end of surgery before emergence from GA.
|
Lung ultrasound assessment of postoperative pulmonary atelectasis at the end of surgery. The Lung Ultrasound Score (LUS): the key points based on ultrasound findings: I. 0 points: (N) Normal aeration (presence of lung sliding with A-lines or <2 separate B-lines). II. 1 point: (B1) Moderate loss of lung aeration (≥3 well-defined B lines). III. 2 points: (B2) Severe loss of lung aeration (coalescing B-lines). IV. 3 points: (C) Complete loss of lung aeration (pulmonary consolidations). Total Score: points will be distributed according to the worst ultrasound pattern observed: N = 0, B1 lines = 1, B2 lines = 2, C = 3. The LUS score ranging between 0 and 36 was calculated as the sum of points. |
at the end of surgery before emergence from GA.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Lung ultrasound assessment
Time Frame: before induction of general anesthesia
|
Lung ultrasound assessment of atelectasis
|
before induction of general anesthesia
|
|
Lung ultrasound assessment
Time Frame: 5 minutes post induction of general anesthesia
|
Lung ultrasound assessment of atelectasis
|
5 minutes post induction of general anesthesia
|
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Lung ultrasound assessment
Time Frame: 15 minutes after patients arrive to PACU
|
Lung ultrasound assessment of atelectasis
|
15 minutes after patients arrive to PACU
|
|
Lung ultrasound assessment
Time Frame: 60 minutes after patients arrive to PACU
|
Lung ultrasound assessment of atelectasis
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60 minutes after patients arrive to PACU
|
|
arterial blood gases
Time Frame: 5 minutes post induction of general anesthesia
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Pao2, spo2, paco2, pao2/fio2
|
5 minutes post induction of general anesthesia
|
|
arterial blood gases
Time Frame: before emergence from general anesthesia
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Pao2, spo2, paco2, pao2/fio2
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before emergence from general anesthesia
|
|
arterial blood gases
Time Frame: 15 minutes after patients arrive to PACU
|
Pao2, spo2, paco2, pao2/fio2
|
15 minutes after patients arrive to PACU
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Hamed M Wally Allah, Al-Azhar University
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- AZAST/MD/209/MARCH/2024
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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