Which Ventilatory Strategy is Better for Lung in Upper Abdominal Surgeries?

Overview

Ventilated Patients especially those undergoing upper abdominal surgeries are prone to lung atelectasis. They are at risk of adverse effects secondary to inadequate lung ventilation. Applied PEEP and Recruitment maneuver are thought to enhance lung aeration under general anesthesia which could be assessed by ultrasound.

Full Title of Study: “Ultrasonographic Assessment of Atelectasis in Major Upper Abdominal Surgeries With Different Ventilatory Strategies”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Double (Participant, Outcomes Assessor)
  • Study Primary Completion Date: June 2022

Detailed Description

The aim of our study is to assess the effect of using PEEP with and without recruitment maneuver on atelectasis and lung aeration during open upper abdominal surgeries by ultrasonography. Application of PEEP improves intraoperative oxygenation and thus could minimize the incidence of postoperative atelectasis and respiratory complications during abdominal surgeries. A recent study found that PEEP and RM prevented intraoperative aeration loss, which didn't persist after extubation when comparing effects of positive end-expiratory pressure/recruitment maneuvers with zero end-expiratory pressure on atelectasis during open gynecological surgery by ultrasonography

Interventions

  • Procedure: Low PEEP
    • Patients will be ventilated with a PEEP of 4 cm H2O and no RMs throughout the study
  • Procedure: High PEEP
    • PEEP of 10 cm H2O will be applied
  • Procedure: High PEEP/RM
    • PEEP of 10 cm H2O and RM (30 cm H2O for 30 s) immediately after the second lung ultrasonographic examination and repeated every 30 minutes till emergence
  • Device: Lung ultrasonogrphy assessment
    • The thorax will divided into 12 quadrants, each of them will be assigned a score of 0-3 as 0, normal lung sliding with fewer than three single B lines three or more B lines coalescent B lines consolidated lung. The LUS (0-36) will be calculated with higher scores indicating more aeration loss

Arms, Groups and Cohorts

  • Placebo Comparator: Low PEEP
    • Low positive end-expiratory pressure (PEEP) and no recruitment maneuver (RM)
  • Active Comparator: High PEEP
    • High positive end-expiratory pressure (PEEP)
  • Active Comparator: High PEEP/RM
    • High positive end-expiratory pressure (PEEP) and recruitment maneuver (RM)

Clinical Trial Outcome Measures

Primary Measures

  • Pre-emergence LUS score
    • Time Frame: intraoperative before recovery from anesthesia
    • Lung ultrasonography score (LUS score) between groups at the end of surgery (just before emergence) as a lower LUS indicates better lung aeration.

Secondary Measures

  • Lung ultrasonography score (LUS score)
    • Time Frame: preoperative, intraoperative for anesthesia duration to 1 hour postoperative
    • Lung ultrasonography score (LUS score) between groups
  • Heart rate
    • Time Frame: preoperative, intraoperative for anesthesia duration to 1 hour postoperative
    • heart rate between groups at each time point of LUS score performance
  • Mean blood pressure
    • Time Frame: preoperative, intraoperative to 1 hour postoperative
    • mean arterial blood pressure between groups at each time point of LUS score performance
  • oxygen saturation
    • Time Frame: preoperative, intraoperative to 1 hour postoperative
    • patient oxygen saturation between groups at each time point of LUS score performance
  • End-tidal carbon dioxide tension
    • Time Frame: intraoperative for anesthesia duration
    • end tidal CO2 between groups post induction, post recruitment and before extubation
  • Arterial partial pressure of oxygen (PaO2)
    • Time Frame: Intraoperative and 15 min postoperative
    • arterial blood gases post induction, before extubation and at the PACU
  • Arterial partial pressure of carbon dioxide (PaCO2)
    • Time Frame: Intraoperative and 15 min postoperative
    • arterial blood gases post induction, before extubation and at the PACU
  • PaO2/FiO2
    • Time Frame: Intraoperative and 15 min postoperative
    • arterial blood gases post induction, before extubation and at the PACU
  • Peak inspiratory pressure
    • Time Frame: intraoperative for anesthesia duration
    • peak inspiratory pressure between groups after intubation
  • Postoperative pulmonary complications (PPCs)
    • Time Frame: 5 days
    • PPCs include (pneumothorax, pleural effusion, pulmonary collapse, atelectasis, pneumonia, acute respiratory distress syndrome (ARDS), or pulmonary aspiration).

Participating in This Clinical Trial

Inclusion Criteria

  • American Society of Anesthesiologists' physical status grades I, II, and III. Exclusion Criteria:

  • Patient refusal. – Psychiatric diseases. – Body Mass Index > 35 Kg/m2. – Previous intrathoracic procedures. – History of severe obstructive pulmonary disease. – History of severe restrictive lung disease. – Pulmonary arterial hypertension ( systolic pulmonary arterial pressure >40 mmHg). – Pregnancy.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Mansoura University
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Aboelnour E Badran, MD, Study Chair, Professor of Anesthesia and Surgical Intensive Care
    • Hanaa M EL- Bendary, MD, Study Director, Assistant Professor of Anesthesia and Surgical Intensive Care

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