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Trial record 7 of 31 for:    Recruiting, Not yet recruiting, Available Studies | "Pulmonary Atelectasis"

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

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ClinicalTrials.gov Identifier: NCT03351946
Recruitment Status : Recruiting
First Posted : November 24, 2017
Last Update Posted : December 6, 2017
Sponsor:
Information provided by (Responsible Party):
Erland Ostberg, Region Västmanland

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Atelectasis Oxygenation Procedure: ZEEP Procedure: PEEP Not Applicable

Detailed Description:

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Masking Description: Sealed envelopes.
Primary Purpose: Prevention
Official Title: Zero Positive End-expiratory Pressure Applied Before Emergence Preoxygenation Prevents Postoperative Atelectasis - a Randomized Controlled Trial.
Actual Study Start Date : December 4, 2017
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : February 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Collapsed Lung

Arm Intervention/treatment
Active Comparator: ZEEP at awakening

Controlled ventilation with tidal volume of 7 mL/kg of ideal body weight and respiratory frequency 10. Fresh gas flow is set to 1 litre/min with an oxygen mixture of 40%, aiming for an inspired oxygen fraction (FiO2) of 30-35%. Positive end-expiratory pressure (PEEP) is set to 7 or 9 cm H20 (9 if BMI≥25) until start of emergence preoxygenation.

Unless the patient´s SpO2 falls below 90%, the FiO2 remains unchanged throughout the procedure.

First CT scan after completion of surgery, before emergence. After the first CT scan and immediately before start of emergence preoxygenation, this group will have the PEEP exchanged for zero PEEP (ZEEP). ZEEP will remain until the study subjects are extubated. Second CT scan approx. 30 min after extubation.

Procedure: ZEEP
Zero positive end-expiratory pressure (ZEEP) during emergence preoxygenation and awakening.
Other Name: Device: Ventilatory setting ZEEP

Active Comparator: PEEP at awakening

Controlled ventilation with tidal volume of 7 mL/kg of ideal body weight and respiratory frequency 10. Fresh gas flow is set to 1 litre/min with an oxygen mixture of 40%, aiming for an inspired oxygen fraction (FiO2) of 30-35%. Positive end-expiratory pressure (PEEP) is set to 7 or 9 cm H20 (9 if BMI≥25) even after start of emergence preoxygenation.

Unless the patient´s SpO2 falls below 90%, the FiO2 remains unchanged throughout the procedure.

First CT scan after completion of surgery, before emergence. After the first CT scan, this group will have PEEP remained until the study subjects are extubated. Second CT scan approx. 30 min after extubation.

Procedure: PEEP
Positive end-expiratory pressure remains during emergence preoxygenation and awakening and until the study subject is extubated.
Other Name: Device: Ventilatory setting PEEP




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03351946


Contacts
Contact: Erland Östberg, M.D. +46-21-173000 erland.ostberg@regionvastmanland.se
Contact: Lennart Edmark, M.D., Ph.D. +46-21-173000 lennart.edmark@regionvastmanland.se

Locations
Sweden
Department of Anaesthesia and Intensive Care Recruiting
Köping, Sweden
Contact: Erland Östberg, M.D.    +46-13-173000    erland.ostberg@regionvastmanland.se   
Sponsors and Collaborators
Region Västmanland
Investigators
Study Director: Lennart Edmark, M.D., Ph.D. Region Västmanland

Responsible Party: Erland Ostberg, Principal Investigator, Region Västmanland
ClinicalTrials.gov Identifier: NCT03351946     History of Changes
Other Study ID Numbers: Dnr 2017/267
First Posted: November 24, 2017    Key Record Dates
Last Update Posted: December 6, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Please email request to the study principal investigator.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: Data will be available within 6 months of study completion.
Access Criteria: Data access requests will be reviewed by a review panel at the Center for Clinical Research, Västerås. Requestors will be required to sign a data acess agreement.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Erland Ostberg, Region Västmanland:
Atelectasis
Oxygenation
Positive end-expiratory pressure
Mechanical ventilation
General anesthesia
Computed tomography

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