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Peroperative Use of Positive End-expiratory Pressure Prevents Formation of Atelectasis as Studied by Computerised Tomography at End of Surgery

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ClinicalTrials.gov Identifier: NCT02548416
Recruitment Status : Completed
First Posted : September 14, 2015
Last Update Posted : November 21, 2017
Sponsor:
Information provided by (Responsible Party):
Erland Ostberg, Region Västmanland

Tracking Information
First Submitted Date  ICMJE September 1, 2015
First Posted Date  ICMJE September 14, 2015
Last Update Posted Date November 21, 2017
Study Start Date  ICMJE November 2015
Actual Primary Completion Date November 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 29, 2015)
  • Area of atelectasis expressed as centimeter^2 [ Time Frame: Within 1-2 hours, just before emergence from anesthesia.The outcome measure (atelectasis) will be investigated at just one point i.e. end of surgery but before emergence from anaesthesia. ]
    The area of atelectasis in the lungs is assessed by computed tomography (CT) 5-10 mm above the dome of the right diaphragm and expressed in centimeter^2 and as a percentage of the total lung area in the particular scan.
  • Measurement of aeras with different aeration in the particular CT scan. [ Time Frame: Within 1-2 hours, just before emergence from anesthesia.The outcome measure (atelectasis) will be investigated at just one point i.e. end of surgery but before emergence from anaesthesia. ]
    The areas of different aeration are assessed by computed tomography (CT) 5-10 mm above the dome of the right diaphragm and expressed in centimeter^2 and as a percentage of the total lung area in the particular scan.
Original Primary Outcome Measures  ICMJE
 (submitted: September 10, 2015)
Area of atelectasis expressed as centimeter^2 [ Time Frame: Within 1-2 hours, just before emergence from anesthesia.The outcome measure (atelectasis) will be investigated at just one point i.e. end of surgery but before emergence from anaesthesia. ]
The area of atelectasis in the lungs is assessed by computed tomography (CT) 5-10 mm above the dome of the right diaphragm and expressed in centimeter^2 and as a percentage of the total lung area in the particular scan.
Change History Complete list of historical versions of study NCT02548416 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 10, 2015)
  • Oxygenation, oxygen tension in arterial blood expressed in kilo Pascal (kPa) [ Time Frame: Within 1-2 hours, just before emergence from anesthesia. At end of surgery but before emergence from anaesthesia, at the same time as the lungs are investigated by computed tomography. ]
    Arterial blood gas samples will be drawn and analyzed at the same time as the computed tomography scan will be undertaken.
  • Oxygenation, oxygen tension in arterial blood expressed in kilo Pascal (kPa) [ Time Frame: Within 2 hours perioperatively, 15 minutes after extubation. ]
    Arterial blood gas samples will be drawn and analyzed 15 minutes after emergence from anesthesia and extubation.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Peroperative Use of Positive End-expiratory Pressure Prevents Formation of Atelectasis as Studied by Computerised Tomography at End of Surgery
Official Title  ICMJE Peroperative Use of Positive End-expiratory Pressure Prevents Formation of Atelectasis as Studied by Computerised Tomography at End of Surgery
Brief Summary

Atelectasis is common during and after general anaesthesia and a number of interventions have been suggested in order to prevent their formation. The use of Positive End Expiratory Pressure (PEEP) during general anaesthesia has in recent years been questioned.

The investigators hypothesize that the use of PEEP as a single intervention improves oxygenation and prevents atelectasis as investigated by computed tomography compared to a control group with zero PEEP.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Atelectasis
Intervention  ICMJE
  • Procedure: Positive end-expiratory pressure

    Induction of anaesthesia is performed in a conventional manner using a target controlled infusion of propofol and remifentanil. Intubation of the trachea is facilitated by rocuronium.

    As soon as correct position of the endotracheal tube is confirmed, controlled ventilation is started with a tidal volume of 7 mL/kg body weight and a respiratory frequency of 10. The 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 is set to 6 or 8 cm H20 (8 if BMI>25) in the intervention group.

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

  • Procedure: Control group, zero PEEP

    Induction of anaesthesia is performed in a conventional manner using a target controlled infusion of propofol and remifentanil. Intubation of the trachea is facilitated by rocuronium. As soon as correct position of the endotracheal tube is confirmed, controlled ventilation is started with a tidal volume of 7 mL/kg body weight and a respiratory frequency of 10. The 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%. Zero PEEP is used.

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

Study Arms  ICMJE
  • Active Comparator: PEEP group
    Induction and maintenance of anaesthesia in a conventional manner. Peroperative ventilatory settings using positive end-expiratory pressure.
    Intervention: Procedure: Positive end-expiratory pressure
  • Active Comparator: Control group zero PEEP
    Induction and maintenance of anaesthesia in a conventional manner. Peroperative ventilatory settings using zero end-expiratory pressure.
    Intervention: Procedure: Control group, zero PEEP
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 10, 2015)
24
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2016
Actual Primary Completion Date November 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy subjects, American Society of Anesthesiology (ASA) I-II.
  • Patients scheduled for non-abdominal day case surgery under general anaesthesia.

Exclusion Criteria:

  • ASA class III or higher.
  • Body Mass Index (BMI) 30 or higher.
  • Arterial oxygen saturation (SpO2) <96% breathing air.
  • Chronic Obstructive Pulmonary Disease (COPD).
  • Ischaemic heart disease.
  • Known or anticipated difficult airway.
  • 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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02548416
Other Study ID Numbers  ICMJE Dnr 2015/338
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Erland Ostberg, Region Västmanland
Study Sponsor  ICMJE Region Västmanland
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Lennart Edmark Region Västmanland
PRS Account Region Västmanland
Verification Date November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP