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

This study has been completed.
Sponsor:
Collaborator:
Centre de Recherche du Centre Hospitalier de l'Université de Montréal
Information provided by (Responsible Party):
Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier:
NCT02055807
First received: February 3, 2014
Last updated: January 25, 2016
Last verified: January 2016
  Purpose
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.

Condition Intervention
Atelectasis
Other: PEEP and recruitment maneuvers
Other: ZEEP (no PEEP nor recruitment maneuver)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Role of Lung Ultrasound Imaging in the Comparison of Two Mechanical Ventilation Strategies During Laparotomy.

Resource links provided by NLM:


Further study details as provided by Centre hospitalier de l'Université de Montréal (CHUM):

Primary Outcome Measures:
  • Lung aeration [ Time Frame: Post-induction to pre-emergence of anesthesia - Day 0 ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Prior and after the first recruitment maneuver during general anesthesia - Day 0 ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Lung aeration score prior and after intubation - Day 0 ] [ Designated as safety issue: Yes ]
    Estimate development of atelectasis secondary to intubation.

  • Atelectasis secondary to extubation [ Time Frame: Lung aeration score prior and after extubation - Day 0 ] [ Designated as safety issue: Yes ]
    Estimate development of atelectasis secondary to extubation.


Enrollment: 44
Study Start Date: February 2015
Study Completion Date: December 2015
Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PEEP and recruitment maneuvers
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.
Other: PEEP and recruitment maneuvers
Active Comparator: ZEEP (Zero end-expiratory pressure)
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.
Other: ZEEP (no PEEP nor recruitment maneuver)

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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02055807

Locations
Canada, Quebec
Centre Hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec, Canada, H2L 4M1
Sponsors and Collaborators
Centre hospitalier de l'Université de Montréal (CHUM)
Centre de Recherche du Centre Hospitalier de l'Université de Montréal
Investigators
Principal Investigator: Martin Girard, MD, FRCPC Centre hospitalier de l'Université de Montréal (CHUM)
  More Information

Responsible Party: Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier: NCT02055807     History of Changes
Other Study ID Numbers: 13.293 
Study First Received: February 3, 2014
Last Updated: January 25, 2016
Health Authority: Canada: Ethics Review Committee

Keywords provided by Centre hospitalier de l'Université de Montréal (CHUM):
Atelectasis
Ultrasound
Recruitment maneuver
Positive end-expiratory pressure

Additional relevant MeSH terms:
Pulmonary Atelectasis
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 29, 2016