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

Primary Purpose

Anesthesia Induced Atelectasis

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Low PEEP
High PEEP
High PEEP/RM
Lung ultrasonogrphy assessment
Sponsored by
Mansoura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Anesthesia Induced Atelectasis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Mansoura University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Arm Label

Low PEEP

High PEEP

High PEEP/RM

Arm Description

Low positive end-expiratory pressure (PEEP) and no recruitment maneuver (RM)

High positive end-expiratory pressure (PEEP)

High positive end-expiratory pressure (PEEP) and recruitment maneuver (RM)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
May 2, 2021
Last Updated
May 2, 2021
Sponsor
Mansoura University
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1. Study Identification

Unique Protocol Identification Number
NCT04872361
Brief Title
Which Ventilatory Strategy is Better for Lung in Upper Abdominal Surgeries?
Official Title
Ultrasonographic Assessment of Atelectasis in Major Upper Abdominal Surgeries With Different Ventilatory Strategies
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2021 (Anticipated)
Primary Completion Date
June 2022 (Anticipated)
Study Completion Date
October 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mansoura University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anesthesia Induced Atelectasis

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
Double-blind (Participant, Outcomes Assessor).
Allocation
Randomized
Enrollment
117 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Low PEEP
Arm Type
Placebo Comparator
Arm Description
Low positive end-expiratory pressure (PEEP) and no recruitment maneuver (RM)
Arm Title
High PEEP
Arm Type
Active Comparator
Arm Description
High positive end-expiratory pressure (PEEP)
Arm Title
High PEEP/RM
Arm Type
Active Comparator
Arm Description
High positive end-expiratory pressure (PEEP) and recruitment maneuver (RM)
Intervention Type
Procedure
Intervention Name(s)
Low PEEP
Intervention Description
Patients will be ventilated with a PEEP of 4 cm H2O and no RMs throughout the study
Intervention Type
Procedure
Intervention Name(s)
High PEEP
Intervention Description
PEEP of 10 cm H2O will be applied
Intervention Type
Procedure
Intervention Name(s)
High PEEP/RM
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
Lung ultrasonogrphy assessment
Intervention Description
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
Primary Outcome Measure Information:
Title
Pre-emergence LUS score
Description
Lung ultrasonography score (LUS score) between groups at the end of surgery (just before emergence) as a lower LUS indicates better lung aeration.
Time Frame
intraoperative before recovery from anesthesia
Secondary Outcome Measure Information:
Title
Lung ultrasonography score (LUS score)
Description
Lung ultrasonography score (LUS score) between groups
Time Frame
preoperative, intraoperative for anesthesia duration to 1 hour postoperative
Title
Heart rate
Description
heart rate between groups at each time point of LUS score performance
Time Frame
preoperative, intraoperative for anesthesia duration to 1 hour postoperative
Title
Mean blood pressure
Description
mean arterial blood pressure between groups at each time point of LUS score performance
Time Frame
preoperative, intraoperative to 1 hour postoperative
Title
oxygen saturation
Description
patient oxygen saturation between groups at each time point of LUS score performance
Time Frame
preoperative, intraoperative to 1 hour postoperative
Title
End-tidal carbon dioxide tension
Description
end tidal CO2 between groups post induction, post recruitment and before extubation
Time Frame
intraoperative for anesthesia duration
Title
Arterial partial pressure of oxygen (PaO2)
Description
arterial blood gases post induction, before extubation and at the PACU
Time Frame
Intraoperative and 15 min postoperative
Title
Arterial partial pressure of carbon dioxide (PaCO2)
Description
arterial blood gases post induction, before extubation and at the PACU
Time Frame
Intraoperative and 15 min postoperative
Title
PaO2/FiO2
Description
arterial blood gases post induction, before extubation and at the PACU
Time Frame
Intraoperative and 15 min postoperative
Title
Peak inspiratory pressure
Description
peak inspiratory pressure between groups after intubation
Time Frame
intraoperative for anesthesia duration
Title
Postoperative pulmonary complications (PPCs)
Description
PPCs include (pneumothorax, pleural effusion, pulmonary collapse, atelectasis, pneumonia, acute respiratory distress syndrome (ARDS), or pulmonary aspiration).
Time Frame
5 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aboelnour E Badran, MD
Organizational Affiliation
Professor of Anesthesia and Surgical Intensive Care
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Hanaa M EL- Bendary, MD
Organizational Affiliation
Assistant Professor of Anesthesia and Surgical Intensive Care
Official's Role
Study Director
Facility Information:
Facility Name
Mansoura University
City
Mansoura
State/Province
DK
ZIP/Postal Code
050
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

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

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