Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 38 of 5997 for:    zero

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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

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.


Condition or disease Intervention/treatment Phase
Atelectasis Procedure: Positive end-expiratory pressure Procedure: Control group, zero PEEP Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Peroperative Use of Positive End-expiratory Pressure Prevents Formation of Atelectasis as Studied by Computerised Tomography at End of Surgery
Study Start Date : November 2015
Actual Primary Completion Date : November 2016
Actual Study Completion Date : November 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: PEEP group
Induction and maintenance of anaesthesia in a conventional manner. Peroperative ventilatory settings using positive end-expiratory pressure.
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.


Active Comparator: Control group zero PEEP
Induction and maintenance of anaesthesia in a conventional manner. Peroperative ventilatory settings using zero end-expiratory pressure.
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.





Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

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).

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): NCT02548416


Locations
Layout table for location information
Sweden
Region Västmanland
Köping, Sweden
Sponsors and Collaborators
Region Västmanland
Investigators
Layout table for investigator information
Study Director: Lennart Edmark Region Västmanland

Layout table for additonal information
Responsible Party: Erland Ostberg, M.D., Region Västmanland
ClinicalTrials.gov Identifier: NCT02548416     History of Changes
Other Study ID Numbers: Dnr 2015/338
First Posted: September 14, 2015    Key Record Dates
Last Update Posted: November 21, 2017
Last Verified: November 2016

Keywords provided by Erland Ostberg, Region Västmanland:
Atelectasis
Positive End-Expiratory Pressure
Oxygenation
Anaesthesia
Computed tomography

Additional relevant MeSH terms:
Layout table for MeSH terms
Pulmonary Atelectasis
Lung Diseases
Respiratory Tract Diseases
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs