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Mechanical Ventilation of Obese Patients During Oral Surgical Procedures

Primary Purpose

Obesity

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
low PEEP
ARM
high PEEP
Sponsored by
Klarić, Vlasta, M.D.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring mechanical ventilation, obesity, oral-surgical procedures

Eligibility Criteria

30 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • body mass index greater than 30 kg / m2
  • surgical operation in the area of the oral cavity in general endotracheal anesthesia - cystectomy, alveotomy, mandible and maxilla osteosynthesis after jaw trauma, operation of retained and affected teeth, orthodontic surgical treatment of jaw deformity, benign tumor surgery
  • ASA (American Society of Anesthesiologists) Classification of Patients 2-3
  • duration of general endotracheal anesthesia from 1 to 2.5 hours

Exclusion Criteria:

  • Allergy to anesthetics
  • previous lung operations
  • documented heart disease (NYHA II, III)
  • Pulmonary disease (asthma, COPD)
  • Obstructive pulmonary function disorders according to spirometry: FVC(forced vital capacity) may and may not be normal, FEV1(forced expiratory volume at one second) <80%, FEV1 / FVC <80%)
  • neuromuscular disease
  • clinical sign of cardiovascular disease established during preoperative treatment
  • pregnancy
  • Patients who, for some reason after surgery, have to remain intubated and mechanically ventilated in the Intensive Medicine Unit
  • refuse to sign informed consent

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Experimental

    Experimental

    Arm Label

    PEEP 4

    PEEP 7 & ARM

    PEEP 10 & ARM

    Arm Description

    Active Comparator low PEEP: obese patient during oral-surgical procedures under general anesthesia ventilated with Positive endexpiratory pressure (PEEP) 4 cm H2O(water)

    Experimental ARM & Experimental high PEEP: obese patient during oral-surgical procedures under general anesthesia ventilated with PEEP( positive endexpiratory pressure) 7 cm H2O with ARM(alveolar recruitment maneuver) provided every 30 min

    Experimental ARM & Experimental high PEEP:obese patient during oral-surgical procedures under general anesthesia ventilated with PEEP( positive endexpiratory pressure) 10 cm H2O with ARM(alveolar recruitment maneuver) provided every 30 min

    Outcomes

    Primary Outcome Measures

    preoperative and postoperative change in arterial blood gas analysis within and between groups of patients
    preoperative blood gas analysis measured an hour before induction and compared with blood gas analysis measured four times in postoperative period, after three different strategies of mechanical ventilation.Blood gas analysis will be compared within a group and between the groups.

    Secondary Outcome Measures

    change in preoperative and postoperative degree of dyspnoea measured on Visual Analog Scale
    the degree of dyspnea in the early postoperative period between and within groups and compared with preoperative status. The degree of dyspnoea was determined by the participants on the Visual Analog Scale (0-10). Change From Baseline in dyspnoea Scores on the Visual Analog Scale at 24 hours were measured.
    The connection between the various risks of difficult intubation and obesity.
    morphological characteristics of oral cavity of obese patients,as indicators of the risk of severe intubation, such as interdental spacing in open mouth, type of bite, Mallampati Classification , Cormack-Lehane classification, thyromental and sterno-mental distance and anatomical anomaly of the face . Compare their association with impaired ventilation and / or intubation according to body mass index through study completion
    PEEP effects on MAP
    intraoperative effect of different PEEP values on systemic circulatory stability by measuring systolic and diastolic blood pressure and mean arterial blood pressure (MAP).
    ARM(alveolar recruitment maneuver) effects on MAP
    intraoperative effect of lung recruitment maneuvers on systemic circulatory stability by measuring systolic and diastolic blood pressure and mean arterial blood pressure (MAP).

    Full Information

    First Posted
    April 27, 2017
    Last Updated
    May 8, 2017
    Sponsor
    Klarić, Vlasta, M.D.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03144609
    Brief Title
    Mechanical Ventilation of Obese Patients During Oral Surgical Procedures
    Official Title
    Impact of Protective Mechanical Ventilation of Obese Patients on the Postoperative Respiratory Function During Oral Surgical Procedures
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    November 2015 (Actual)
    Primary Completion Date
    April 2017 (Actual)
    Study Completion Date
    August 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Klarić, Vlasta, M.D.

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The prevalence of obese patients in a great number of patients scheduled for elective surgery under general anesthesia has been on the increase. Recent studies suggest an intraoperative protective mechanical ventilation for the obese. Surgical procedures in the oral cavity increase the risk of perioperative complications of obese patients. By making this randomized clinical study, investigators want to determine whether the protective intraoperative ventilation with the use of higher positive end-expiratory pressure and recruitment maneuvers compared to ventilation with low positive end-expiratory pressure and without recruitments cause better postoperative respiratory function parameters of obese patients during oral surgical procedures. Investigators also aim to establish the fact which value of a positive end-expiratory pressure has a favorable impact on the respiratory function without negative hemodynamic effect.
    Detailed Description
    Oral surgeries of obese patients in general endotracheal anesthesia are a special challenge as in the most extensive types of interventions any form of regional anesthesia is inadequate, duration of surgery is short but requires deep level of anesthesia after which a quick awakening and most rapid release from hospital are expected, with a known high perioperative risk complications of obese patients. Oral surgical procedures in the oral cavity due to possible postoperative upper airway oedema increase the risk of postoperative hypoxia in obese patients. Therefore, it is important to intraoperatively mechanically ventilate obese patients with the aim of good ventilation-perfusion ratio without creating new atelectasis, to minimize the risk of postoperative respiratory decompensation and to provide rapid recovery. As the prevalence of obesity in the world increases as chronic diseases, the number of obese patients scheduled for oral surgery is growing. Studies involving different ways of intraoperative mechanical ventilation of obese patients are mostly processed laparoscopic abdominal studies that can not exclude the additional effect of intraabdominal pressure on the formation of pulmonary atelectasis.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Obesity
    Keywords
    mechanical ventilation, obesity, oral-surgical procedures

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    75 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    PEEP 4
    Arm Type
    Active Comparator
    Arm Description
    Active Comparator low PEEP: obese patient during oral-surgical procedures under general anesthesia ventilated with Positive endexpiratory pressure (PEEP) 4 cm H2O(water)
    Arm Title
    PEEP 7 & ARM
    Arm Type
    Experimental
    Arm Description
    Experimental ARM & Experimental high PEEP: obese patient during oral-surgical procedures under general anesthesia ventilated with PEEP( positive endexpiratory pressure) 7 cm H2O with ARM(alveolar recruitment maneuver) provided every 30 min
    Arm Title
    PEEP 10 & ARM
    Arm Type
    Experimental
    Arm Description
    Experimental ARM & Experimental high PEEP:obese patient during oral-surgical procedures under general anesthesia ventilated with PEEP( positive endexpiratory pressure) 10 cm H2O with ARM(alveolar recruitment maneuver) provided every 30 min
    Intervention Type
    Procedure
    Intervention Name(s)
    low PEEP
    Other Intervention Name(s)
    low positive endexpiratory pressure
    Intervention Description
    The control group consisted of obese patients mechanically ventilated by a standardized volume-controlled breathing mode with low respiratory volume without alveolar recruitment maneuver and using low values of PEEP up to 4 cm H2O.
    Intervention Type
    Procedure
    Intervention Name(s)
    ARM
    Other Intervention Name(s)
    alveolar recruitment maneuver
    Intervention Description
    The experimental groups also consisted of obese patients mechanically ventilated by a volume-controlled breathing mode with low respiratory volume 7 ml/kg ideal body mass, but with alveolar recruitment maneuver performed immediately after induction, followed every 30 minutes during the hemodynamic stable condition under operation.
    Intervention Type
    Procedure
    Intervention Name(s)
    high PEEP
    Other Intervention Name(s)
    high positive endexpiratory pressure
    Intervention Description
    The experimental groups also consisted of obese patients mechanically ventilated by a volume-controlled breathing mode with low respiratory volume 7 ml/kg ideal body mass, but with higher PEEP, provided that the upper limit of 40 cm H20 was not exceeded.
    Primary Outcome Measure Information:
    Title
    preoperative and postoperative change in arterial blood gas analysis within and between groups of patients
    Description
    preoperative blood gas analysis measured an hour before induction and compared with blood gas analysis measured four times in postoperative period, after three different strategies of mechanical ventilation.Blood gas analysis will be compared within a group and between the groups.
    Time Frame
    Preoperative parameters were compared with change in early postoperative parameter. Early postoperative measurements were measurements after 15 minutes from the operation, then in the first and third hours, and 24 hours after the operation.
    Secondary Outcome Measure Information:
    Title
    change in preoperative and postoperative degree of dyspnoea measured on Visual Analog Scale
    Description
    the degree of dyspnea in the early postoperative period between and within groups and compared with preoperative status. The degree of dyspnoea was determined by the participants on the Visual Analog Scale (0-10). Change From Baseline in dyspnoea Scores on the Visual Analog Scale at 24 hours were measured.
    Time Frame
    25 perioperative hours.Preoperative degree was measured one hour before the start of the operation. Early postoperative measurements were measured 15 min after the operation started, then in the first, third and 24th hours after surgery
    Title
    The connection between the various risks of difficult intubation and obesity.
    Description
    morphological characteristics of oral cavity of obese patients,as indicators of the risk of severe intubation, such as interdental spacing in open mouth, type of bite, Mallampati Classification , Cormack-Lehane classification, thyromental and sterno-mental distance and anatomical anomaly of the face . Compare their association with impaired ventilation and / or intubation according to body mass index through study completion
    Time Frame
    up to 1 day:Visual Scale Cormack- Lehane classification was measured at laryngoscopy for intubation by investigator, all other measurements were measured once at preoperative Anesthetic examination
    Title
    PEEP effects on MAP
    Description
    intraoperative effect of different PEEP values on systemic circulatory stability by measuring systolic and diastolic blood pressure and mean arterial blood pressure (MAP).
    Time Frame
    1-2,5 intraoperative hours.Intraoperative measurements were performed 5 min before and 5 min after induction, then every 30 minutes during operation.Change in MAP includes only period from the beginning operation to the end of surgery and extubation.
    Title
    ARM(alveolar recruitment maneuver) effects on MAP
    Description
    intraoperative effect of lung recruitment maneuvers on systemic circulatory stability by measuring systolic and diastolic blood pressure and mean arterial blood pressure (MAP).
    Time Frame
    1-2,5 intraoperative hours.Intraoperative measurements were performed 5 min before and 5 min after induction, then every 30 min during operation, and 5 min after ARM is performed. Change in MAP includes period from the beginning to the end of operation

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    30 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: body mass index greater than 30 kg / m2 surgical operation in the area of the oral cavity in general endotracheal anesthesia - cystectomy, alveotomy, mandible and maxilla osteosynthesis after jaw trauma, operation of retained and affected teeth, orthodontic surgical treatment of jaw deformity, benign tumor surgery ASA (American Society of Anesthesiologists) Classification of Patients 2-3 duration of general endotracheal anesthesia from 1 to 2.5 hours Exclusion Criteria: Allergy to anesthetics previous lung operations documented heart disease (NYHA II, III) Pulmonary disease (asthma, COPD) Obstructive pulmonary function disorders according to spirometry: FVC(forced vital capacity) may and may not be normal, FEV1(forced expiratory volume at one second) <80%, FEV1 / FVC <80%) neuromuscular disease clinical sign of cardiovascular disease established during preoperative treatment pregnancy Patients who, for some reason after surgery, have to remain intubated and mechanically ventilated in the Intensive Medicine Unit refuse to sign informed consent
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Vlasta Klarić, M.D.
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Mechanical Ventilation of Obese Patients During Oral Surgical Procedures

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