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NCT Number: NCT02055807

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

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.

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Key information

Conditions

Atelectasis Lung Diseases Pulmonary Atelectasis Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebec, H2L 4M1, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PEEP and recruitment maneuvers

Other

ZEEP (no PEEP nor recruitment maneuver)

Other

Primary outcomes

  1. Lung aeration

    Time frame: Post-induction to pre-emergence of anesthesia - Day 0

    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 outcomes

  1. Re-aeration following recruitment maneuvers

    Time frame: Prior and after the first recruitment maneuver during general anesthesia - Day 0

    Assess lung re-aeration following a recruitment maneuver by ultrasound imaging (lung aeration score pre/post the first recruitment maneuver during general anesthesia).

  2. Atelectasis secondary to induction

    Time frame: Lung aeration score prior and after intubation - Day 0

    Estimate development of atelectasis secondary to intubation.

  3. Atelectasis secondary to extubation

    Time frame: Lung aeration score prior and after extubation - Day 0

    Estimate development of atelectasis secondary to extubation.

Sponsors and collaborators

Lead sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Other

Collaborators

  • Centre de Recherche du Centre Hospitalier de l'Université de Montréal

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Feb 5, 2014
Registry last updated
Jan 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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