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

Not Applicable

• Conditions: Anesthesia Induced Atelectasis
• Interventions: Procedure: High PEEP/RM; Procedure: Low PEEP; Procedure: High PEEP; Device: Lung ultrasonogrphy assessment

• Registration Number: NCT04872361
• Lead Sponsor: Mansoura University

Brief Summary

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.

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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2021-05
• Study Start: 2021-05-01
• Study First Submitted: 2021-05-02
• Study First Submitted QC: 2021-05-02
• Last Update Submitted: 2021-05-02
• Study First Posted: 2021-05-04
• Last Update Posted: 2021-05-04
• Primary Completion: 2022-06
• Study Completion: 2022-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 117

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low PEEP	Lung ultrasonogrphy assessment	Low positive end-expiratory pressure (PEEP) and no recruitment maneuver (RM)
High PEEP/RM	High PEEP/RM	High positive end-expiratory pressure (PEEP) and recruitment maneuver (RM)
High PEEP	Lung ultrasonogrphy assessment	High positive end-expiratory pressure (PEEP)
Low PEEP	Low PEEP	Low positive end-expiratory pressure (PEEP) and no recruitment maneuver (RM)
High PEEP	High PEEP	High positive end-expiratory pressure (PEEP)
High PEEP/RM	Lung ultrasonogrphy assessment	High positive end-expiratory pressure (PEEP) and recruitment maneuver (RM)

Primary Outcome Measures

Name	Time	Method
Pre-emergence LUS score	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 Outcome Measures

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

Trial Locations

Locations (1)

Mansoura University; 🇪🇬 Mansoura, DK, Egypt