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

Anesthesia Induced Atelectasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04872361
• Other study ID #: MFM-IRB.MD.21.01.412
• Status: Enrolling by invitation
• Phase: N/A
• Start date: May 1, 2021
• Est. completion date: October 2022

Study information

• Verified date: May 2021
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 117
• Est. completion date: October 2022
• Est. primary completion date: June 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anesthesia Induced Atelectasis
• Pulmonary Atelectasis

Intervention

Procedure:
• Low PEEP
Patients will be ventilated with a PEEP of 4 cm H2O and no RMs throughout the study
• High PEEP
PEEP of 10 cm H2O will be applied
• 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

Locations

Country	Name	City	State
Egypt	Mansoura University	Mansoura	DK

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

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