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Postoperative Lung Collapse Prevention

Primary Purpose

Atelectasis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Positive pressure
Sponsored by
Lennart Magnusson
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Atelectasis focused on measuring anesthesia, general

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • patient undergoing gynaecological laparoscopic surgery under general anesthesia

Exclusion Criteria:

  • BMI > 30 kg/m2 or < 17 kg/m2
  • pregnancy; hypoxemic disease
  • Delay between extubation and CT-scan > 20 minutes

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    Control group

    Pressure support group

    Arm Description

    Extubation procedure following standard of care

    Extubation procedure is performed with 100% of O2 but with application of positive pressure before and after extubation

    Outcomes

    Primary Outcome Measures

    Atelectatic surface
    Whole lung CT scan with a special low doses protocol was obtained at end-expiratory position (at functional residual capacity)

    Secondary Outcome Measures

    Full Information

    First Posted
    January 13, 2021
    Last Updated
    February 1, 2021
    Sponsor
    Lennart Magnusson
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04712084
    Brief Title
    Postoperative Lung Collapse Prevention
    Official Title
    Postoperative Atelectasis Prevention by Application of PEEP and Pressure Support Ventilation: a Prospective Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    July 3, 2013 (Actual)
    Primary Completion Date
    July 22, 2014 (Actual)
    Study Completion Date
    July 22, 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Lennart Magnusson

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    General anaesthesia is known to promote lung collapse (atelectasis) which will persist in the postoperative period. Inflating the lung to a pressure of 40 cmH2O, called a vital capacity manoeuvre (VCM), performed a few minutes before extubation followed by the use of 40% of O2 will prevent postoperative atelectasis formation. This is not the case if VCM is followed by application of 100% of O2. However the use of 100% of O2 before tracheal extubation is still recommended for safety reason. Application of PEEP associated with pressure controlled ventilation before intubation prevents atelectasis formation despite the use of 100% of O2. The goal of our study was to show that performing a VCM 15 minutes before arousal followed by application of PEEP and pressure support ventilation (PSV) before and after tracheal extubation will prevent the recurrence of atelectasis despite the use of 100% of O2. Materials and Methods With the ethic committee for research on human beings approval, the investigators randomly assigned 16 non-obese patients scheduled for a gynaecological laparoscopic surgery in two groups. At the end of the surgery the investigators performed a VCM (40cmH2O applied for 12 seconds), then O2 was increased to 100% in both groups. In the patients of the study group, a PEEP of 6 cmH2O was applied associated with a PSV of 8 cmH2O. This was continued after the extubation for 3 minutes. The O2 was then decreased to 40% and, when the expired oxygen saturation was < 50%, PEEP and PSV were removed. For the patients in the control group, no positive pressure was applied during spontaneous ventilation (PEEP = 0 and no PSV). The atelectasis were then measured by computed tomographic scanning.
    Detailed Description
    This is a prospective double-blinded study with prior informed written consent obtained from all patients. Study Population Patients aged 18 to 65 years, American Society of Anesthesiologist (ASA) physical status classification I to III, undergoing gynaecological laparoscopic surgery under general anaesthesia were included in this prospective, randomised, double-blinded study. Exclusion criteria were severe pulmonary disease, body mass index (BMI) more than 30 kg /m2 or less than 17, pregnancy or any other disease for which hypoxemia could be harmful. If the delay between extubation and the computed tomography (CT) scan was over 20 minutes, patients were also excluded. Study treatments No premedication was given. General anaesthesia was standardized for all patients. Standard monitoring was applied. General anaesthesia was induced intravenously with fentanyl 1 to 2 μg/kg, propofol 2 to 3 mg/kg, and rocuronium 0.6 mg/kg. The airways were secured by endotracheal intubation. Desflurane was used for maintenance at 1 minimal alveolar concentration (MAC) in 40% oxygen and air. Additional rocuronium was injected in order to maintain a train-of-four ratio (TOF ratio) between 0 and 1/4. Supplemental fentanyl was administered in order to maintain blood pressure and/or heart rate values within a range of 20% compared to baseline values. For ventilation, the investigators used pressure controlled mode with tidal volume guaranteed (pressure controlled - guaranteed volume, General Electrics Datex-Ohmeda Aisys®). The settings of ventilation were, tidal volume 6-8 ml/kg (ideal body weight), frequency 10 - 20 per min. (expired CO2 5.3 - 5.8 kPa), PEEP of 6 cmH2O and I:E ratio 1:2. Fifteen minutes before the end of the surgery, a VCM (40cmH2O applied for 12 seconds) was performed, then O2 was increased to 100% in both groups. Sugamadex (4 mg/kg if TOF <2/4, 2 mg/kg if TOF >2/4) was administered in order to reverse neuromuscular block. General anaesthesia was continued until TOF ratio > 90%. Randomization was performed when spontaneous ventilation resumed. In the study group, inspiratory support of 8 cmH2O was applied associated with PEEP at 6 cmH2O. After extubation, same support was applied by facemask for 3 minutes. O2 was then decreased to 40% and, when the expired oxygen fraction was < 50%, PEEP and PSV were switched off. In the control group, no positive pressure and no PEEP were applied during spontaneous ventilation and 100% of O2 was applied for 3 minutes after extubation with a facemask. Patients were then transported to the CT scan breathing 40% of O2 via a facemask. The peripheral oxygen saturation was continuously monitored by pulse oximetry. Postoperative pain management consisted of the residual effect of intraoperative fentanyl and paracetamol if required. Measurements Whole lung CT scan with a special low doses protocol was obtained at end-expiratory position (at functional residual capacity). Measurement was performed for all the lung and the lungs were also divided in 3 zones (upper, middle and lower). Each right and left lung surfaces were extracted and a window setting of -1000 to +100 Hounsfield Units (HU) was selected to assess the total lung surface. A threshold of -1000 to -500 HU was applied to quantify the amount of normally ventilated lung, a second threshold of -500 to -100 HU was chosen to establish the surface of poorly ventilated lung, and a third threshold of -100 to +100 HU was set to measure the surface of atelectatic lung area. The right and left lungs surface were summed and reported to the total lung surface(18). Study Outcome The primary outcome was diminution of atelectatic and poorly ventilated lung volume in the study group compared to the control group. Statistical Analysis Values are expressed as mean +/- SD. Baseline results and atelectatic surface were compared by a one-way analysis of variance for continuous variables and with X2 for discrete variables. P < 0.05 was considered significant.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Atelectasis
    Keywords
    anesthesia, general

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    prospective double-blinded study Randomization was performed when spontaneous ventilation resumed at the end of the surgery
    Masking
    ParticipantOutcomes Assessor
    Masking Description
    Patient during general anesthesia are not aware of the technique applied. The radiologist calculating the surface of atelectasis is not aware of the technique applied
    Allocation
    Randomized
    Enrollment
    34 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Control group
    Arm Type
    No Intervention
    Arm Description
    Extubation procedure following standard of care
    Arm Title
    Pressure support group
    Arm Type
    Experimental
    Arm Description
    Extubation procedure is performed with 100% of O2 but with application of positive pressure before and after extubation
    Intervention Type
    Procedure
    Intervention Name(s)
    Positive pressure
    Intervention Description
    Inspiratory support of 8 cmH2O was applied associated with PEEP at 6 cmH2O. After extubation, same support was applied by facemask for 3 minutes
    Primary Outcome Measure Information:
    Title
    Atelectatic surface
    Description
    Whole lung CT scan with a special low doses protocol was obtained at end-expiratory position (at functional residual capacity)
    Time Frame
    10 - 20 minutes after extubation

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: patient undergoing gynaecological laparoscopic surgery under general anesthesia Exclusion Criteria: BMI > 30 kg/m2 or < 17 kg/m2 pregnancy; hypoxemic disease Delay between extubation and CT-scan > 20 minutes
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Lennart Magnusson
    Organizational Affiliation
    Hopital cantonal Fribourg
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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