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Completed

NCT Number: NCT03351946

Zero Positive End-expiratory Pressure Before Emergence Prevents Postoperative Atelectasis.

A study on healthy patients undergoing anesthesia for non-abdominal surgery - evaluation of positive end-expiratory pressure versus zero positive end-expiratory pressure on the amount of atelectasis in the early postoperative period.

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Key information

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Anaesthesia and Intensive Care

Köping, Sweden

About this study

Positive end-expiratory pressure (PEEP) is often used during mechanical ventilation to preserve end-expiratory lung volume. After emergence and extubation, this volume will diminish instantly. Some patients will have difficulties to restore functional residual capacity (FRC) during the early phase of recovery. If routine high FIO2 has been delivered together with maintained PEEP prior to extubation, several important prerequisites are established for the development of postoperative atelectasis. The investigators hypothesize that establishing zero positive end-expiratory pressure (ZEEP) immediately prior to emergence preoxygenation, will prevent gas with high oxygen concentration from entering dorso-basal areas of the lungs, and thereby prevent postoperative atelectasis formation.

This randomized controlled study will study patients undergoing non-abdominal day case surgeries under general anesthesia. The patients in the two study groups will receive mechanical ventilation with identical settings, comprising low TV, moderate PEEP, and no RM. At the end of surgery, the lungs will be examined by CT, and any atelectasis areas will be calculated. Randomization will occur after the first CT. The patients will be allocated to zero PEEP (ZEEP) or maintained PEEP during emergence preoxygenation and extubation. Importantly, the intervention group will have ZEEP established while still having low ETO2 levels, prior to any preoxygenation. The study subjects will be examined with CT no.2 approximately thirty min after extubation. Primary endpoint measure will be atelectasis area as a percentage of total lung area. Blood gases will be collected for comparison of oxygenation as a secondary outcome measure.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • American Society of Anesthesiology (ASA) class I-II
  • Non-abdominal day case surgery under general anesthesia

Exclusion criteria

  • Body mass index (BMI) ≥30 kg/m2
  • Arterial oxygen saturation (SpO2) breathing air <95 %
  • Chronic Obstructive Pulmonary Disease (COPD) or symptomatic asthma
  • Symptomatic congestive heart failure
  • Ischemic heart disease
  • Hemoglobin <100 g/L
  • Active smokers
  • Active smokers and ex-smokers with a history of more than 6 pack years.
  • Need for interscalene or supraclavicular plexus block for postoperative pain relief (risk of phrenic nerve paralysis).

Treatment and study plan

ZEEP

Procedure

Zero positive end-expiratory pressure (ZEEP) during emergence preoxygenation and awakening.

Other names: Device: Ventilatory setting ZEEP

PEEP

Procedure

Positive end-expiratory pressure remains during emergence preoxygenation and awakening and until the study subject is extubated.

Other names: Device: Ventilatory setting PEEP

Primary outcomes

  1. Change in atelectasis area

    Time frame: Within 3 hours from induction of anesthesia. First CT after surgery, before emergence. Second CT approx 25 min after extubation. Study complete after that, no further CT.

    Atelectasis area as studied by computed tomography.

Secondary outcomes

  1. Change in oxygenation

    Time frame: Within 3 hours from induction of anesthesia. First blood gas after surgery, before emergence. Second approx 25 min after extubation. Study complete after that, no further blood gases.

    Arterial blood samples will be collected for measurement of arterial oxygen partial pressure.

Sponsors and collaborators

Lead sponsor

Region Västmanland

Other

Registry information

Official study title

Zero Positive End-expiratory Pressure Applied Before Emergence Preoxygenation Prevents Postoperative Atelectasis - a Randomized Controlled Trial.

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Nov 24, 2017
Registry last updated
Sep 5, 2018

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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