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Role of Lung Ultrasound Imaging in the Comparison of Two Mechanical Ventilation Strategies During Laparotomy

Primary Purpose

Atelectasis

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
PEEP and recruitment maneuvers
ZEEP (no PEEP nor recruitment maneuver)
Sponsored by
Centre hospitalier de l'Université de Montréal (CHUM)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atelectasis focused on measuring Atelectasis, Ultrasound, Recruitment maneuver, Positive end-expiratory pressure

Eligibility Criteria

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

Inclusion Criteria:

  • Patients aged 18 years and older
  • Scheduled for surgery by laparotomy (expected to last at least 2 hours)
  • American Society of Anesthesiologists classification: physical status 1-3

Exclusion Criteria:

  • Previous thoracic procedure (thoracic drain, thoracotomy, thoracoscopy)
  • Contraindication to the placement of an arterial line
  • Very severe chronic obstructive pulmonary disease

Sites / Locations

  • Centre Hospitalier de l'Université de Montréal (CHUM)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PEEP and recruitment maneuvers

ZEEP (Zero end-expiratory pressure)

Arm Description

A PEEP of 7 cm H2O will be applied starting after intubation until the end of surgery. Recruitment maneuvers (continuous positive pressure of 30 cm H20 for 30 seconds) will be initiated following intubation and repeated every 30 minutes during surgery and immediately prior to extubation. Lung ultrasound examinations will be performed at different time-points immediately before surgery, during surgery under general anesthesia and after surgery in the recovery room to detect and monitor atelectasis.

No PEEP nor recruitment maneuvers will be used during surgery. Lung ultrasound examinations will be performed at different time-points immediately before surgery, during surgery under general anesthesia and after surgery in the recovery room to detect and monitor atelectasis.

Outcomes

Primary Outcome Measures

Lung aeration
Compare lung aeration between two different mechanical ventilation strategies (with or without PEEP and recruitment maneuvers) using ultrasound imaging and a four point aeration score (0 = normal lung, 1 = moderate aeration loss, 2 = severe aeration loss, 3 = complete aeration loss and consolidation).

Secondary Outcome Measures

Re-aeration following recruitment maneuvers
Assess lung re-aeration following a recruitment maneuver by ultrasound imaging (lung aeration score pre/post the first recruitment maneuver during general anesthesia).
Atelectasis secondary to induction
Estimate development of atelectasis secondary to intubation.
Atelectasis secondary to extubation
Estimate development of atelectasis secondary to extubation.

Full Information

First Posted
February 3, 2014
Last Updated
January 25, 2016
Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
Collaborators
Centre de Recherche du Centre Hospitalier de l'Université de Montréal
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1. Study Identification

Unique Protocol Identification Number
NCT02055807
Brief Title
Role of Lung Ultrasound Imaging in the Comparison of Two Mechanical Ventilation Strategies During Laparotomy
Official Title
Role of Lung Ultrasound Imaging in the Comparison of Two Mechanical Ventilation Strategies During Laparotomy.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
February 2015 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
Collaborators
Centre de Recherche du Centre Hospitalier de l'Université de Montréal

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The use of positive end-expiratory pressure (PEEP) and recruitment maneuvers during laparotomy will limit the development of atelectasis and therefore improve the aeration score.
Detailed Description
Postoperative pulmonary complications contribute to the morbidity of surgical patients. During general anesthesia, up to 90% of patients will develop atelectasis, which is thought to be a major contributing factor to their development. The adjustment of ventilator settings to prevent the occurrence of atelectasis and reduce pulmonary complications remains controversial. Despite the use of similar mechanical ventilation strategies, two recent studies (IMPROVE, PROVHILO) involving 1300 patients diverged in their conclusions regarding the impact of these strategies in the prevention of pulmonary complications. In these studies, the absence of imagery to assess the pulmonary end-result of the different ventilation strategies complicates the interpretation of their results. On arrival in the operating theatre, each patient will undergo a baseline lung ultrasound examination. The anesthetic technique and monitoring will be standardized. The radial artery will be cannulated after induction of anesthesia for blood gas monitoring. Ventilator settings will be adjusted according to randomization. A second lung ultrasound examination will be performed 5 minutes following induction of general anesthesia. In the PEEP group, a lung ultrasound examination will be performed immediately following the first recruitment maneuver. A lung ultrasound examination will also be performed at the end of surgery before emergence of general anesthesia. Fifteen minutes after arrival in the recovery room, a last lung ultrasound examination will be performed. Fraction of inspired oxygen (FiO2) and vital signs will be recorded during each ultrasound examination. Arterial blood samples will be collected simultaneously. The aeration score will be calculated for each lung ultrasound examination.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atelectasis
Keywords
Atelectasis, Ultrasound, Recruitment maneuver, Positive end-expiratory pressure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PEEP and recruitment maneuvers
Arm Type
Experimental
Arm Description
A PEEP of 7 cm H2O will be applied starting after intubation until the end of surgery. Recruitment maneuvers (continuous positive pressure of 30 cm H20 for 30 seconds) will be initiated following intubation and repeated every 30 minutes during surgery and immediately prior to extubation. Lung ultrasound examinations will be performed at different time-points immediately before surgery, during surgery under general anesthesia and after surgery in the recovery room to detect and monitor atelectasis.
Arm Title
ZEEP (Zero end-expiratory pressure)
Arm Type
Active Comparator
Arm Description
No PEEP nor recruitment maneuvers will be used during surgery. Lung ultrasound examinations will be performed at different time-points immediately before surgery, during surgery under general anesthesia and after surgery in the recovery room to detect and monitor atelectasis.
Intervention Type
Other
Intervention Name(s)
PEEP and recruitment maneuvers
Intervention Type
Other
Intervention Name(s)
ZEEP (no PEEP nor recruitment maneuver)
Primary Outcome Measure Information:
Title
Lung aeration
Description
Compare lung aeration between two different mechanical ventilation strategies (with or without PEEP and recruitment maneuvers) using ultrasound imaging and a four point aeration score (0 = normal lung, 1 = moderate aeration loss, 2 = severe aeration loss, 3 = complete aeration loss and consolidation).
Time Frame
Post-induction to pre-emergence of anesthesia - Day 0
Secondary Outcome Measure Information:
Title
Re-aeration following recruitment maneuvers
Description
Assess lung re-aeration following a recruitment maneuver by ultrasound imaging (lung aeration score pre/post the first recruitment maneuver during general anesthesia).
Time Frame
Prior and after the first recruitment maneuver during general anesthesia - Day 0
Title
Atelectasis secondary to induction
Description
Estimate development of atelectasis secondary to intubation.
Time Frame
Lung aeration score prior and after intubation - Day 0
Title
Atelectasis secondary to extubation
Description
Estimate development of atelectasis secondary to extubation.
Time Frame
Lung aeration score prior and after extubation - Day 0

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients aged 18 years and older Scheduled for surgery by laparotomy (expected to last at least 2 hours) American Society of Anesthesiologists classification: physical status 1-3 Exclusion Criteria: Previous thoracic procedure (thoracic drain, thoracotomy, thoracoscopy) Contraindication to the placement of an arterial line Very severe chronic obstructive pulmonary disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Girard, MD, FRCPC
Organizational Affiliation
Centre hospitalier de l'Université de Montréal (CHUM)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier de l'Université de Montréal (CHUM)
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 4M1
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
31733807
Citation
Genereux V, Chasse M, Girard F, Massicotte N, Chartrand-Lefebvre C, Girard M. Effects of positive end-expiratory pressure/recruitment manoeuvres compared with zero end-expiratory pressure on atelectasis during open gynaecological surgery as assessed by ultrasonography: a randomised controlled trial. Br J Anaesth. 2020 Jan;124(1):101-109. doi: 10.1016/j.bja.2019.09.040. Epub 2019 Nov 14.
Results Reference
derived

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Role of Lung Ultrasound Imaging in the Comparison of Two Mechanical Ventilation Strategies During Laparotomy

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