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

Ultrasonographic Assessment of Atelectasis in Major Upper Abdominal Surgeries With Different Ventilatory Strategies

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Anesthesia Induced Atelectasis
• Intervention / Treatment: Procedure: Low PEEP; Device: Lung ultrasonogrphy assessment; Procedure: High PEEP; Procedure: High PEEP/RM

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

• Study Type: Interventional
• Enrollment (Anticipated): 117
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • DK
    • Mansoura, DK, Egypt, 050
      • Mansoura University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Low PEEP; Low positive end-expiratory pressure (PEEP) and no recruitment maneuver (RM)	Procedure: Low PEEP; Patients will be ventilated with a PEEP of 4 cm H2O and no RMs throughout the study; 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
ACTIVE_COMPARATOR: High PEEP; High positive end-expiratory pressure (PEEP)	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; Procedure: High PEEP; PEEP of 10 cm H2O will be applied
ACTIVE_COMPARATOR: High PEEP/RM; High positive end-expiratory pressure (PEEP) and recruitment maneuver (RM)	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; 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Mansoura University
• Investigators: Study Chair: Aboelnour E Badran, MD, Professor of Anesthesia and Surgical Intensive Care; Study Director: Hanaa M EL- Bendary, MD, assistant professor of Anesthesia and Surgical Intensive Care

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): May 1, 2021
• Primary Completion (ANTICIPATED): June 1, 2022
• Study Completion (ANTICIPATED): October 1, 2022

Study Registration Dates

• First Submitted: May 2, 2021
• First Submitted That Met QC Criteria: May 2, 2021
• First Posted (ACTUAL): May 4, 2021

Study Record Updates

• Last Update Posted (ACTUAL): May 4, 2021
• Last Update Submitted That Met QC Criteria: May 2, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Pulmonary Atelectasis
• Other Study ID Numbers: MFM-IRB.MD.21.01.412

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: will be available after completing the study and acceptance for publication
• IPD Sharing Time Frame: after completing the study and acceptance for publication
• IPD Sharing Access Criteria: Sharing Criteria: the data will be accessible to the investigators and PRS administrators with hiding the identifiers for the patients.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No