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PSV on Ventilation Inhomogeneity and Lung Function in Patients Under SB Across LMA (VINHO)

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ClinicalTrials.gov Identifier: NCT02986269
Recruitment Status : Recruiting
First Posted : December 8, 2016
Last Update Posted : January 6, 2021
Sponsor:
Information provided by (Responsible Party):
Walid HABRE, University Hospital, Geneva

Brief Summary:
General anesthesia has been demonstrated to have a negative impact on lung function. Both surgery and patient position influence the perioperative lung function. Laryngeal mask airway (LMA) has been proved to be safe and efficient to maintain the airways patent during general anesthesia. Pressure support ventilation (PSV) with LMA is routinely used in clinical practice. The aim of the present trial is to characterize perioperative changes in lung volume, ventilation inhomogeneity and respiratory mechanics in patients in the lithotomy position and spontaneously breathing through LMA with and without PSV.

Condition or disease Intervention/treatment Phase
Respiratory Function Tests Anesthesia, General Patient Positioning Ventilation Procedure: general anesthesia across LMA Procedure: Spontaneous breathing(SB) Procedure: Pressure Support Ventilation Not Applicable

Detailed Description:

This study is a randomized controlled trial. Participants for this study will be recruited from the Gynecological department of the University Hospitals of Geneva, scheduled for gynecological procedures in the lithotomy position under general anesthesia. A total of 40 patients will be enrolled and randomly assigned into 2 groups: Group SB (spontaneously breathing without PSV) and Group PSV (spontaneously breathing with PSV). Measurements of end-expiratory lung volume (EELV) and ventilation inhomogeneity will be performed in all patients with a nitrogen multiple breath washout method, before and 1 hour after surgery. Similarly, airway resistance (Rrs) and reactance (Xrs) will be measured at the same time by using the Forced Oscillation Technique.

The primary endpoint: Perioperative changes in ventilation inhomogeneity (LCI) and respiratory mechanics (Rrs and Xrs) of patients, positioned in lithotomy and undergoing general anesthesia while breathing spontaneously through LMA with or without PSV.

The secondary endpoints: Presence of respiratory complications, oxygen need in the recovery room, length of stay in the recovery room and in the hospital. Correlation between duration of positioning and surgery with lung function and volume measurements.

Relevance: There are no studies that addressed the value of pressure support ventilation to overcome the potential changes in lung function following spontaneous ventilation across a LMA in the lithotomy position.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
Official Title: The Value of Pressure Support on Ventilation Inhomogeneity and Lung Function in Patients Under Spontaneous Breathing (SB)Across Laryngeal Mask Airway
Actual Study Start Date : April 13, 2018
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Arm Intervention/treatment
Experimental: Group SB

Patient is scheduled for elective conisation or hysteroscopy under general anesthesia. The ventilation mode for this group is spontaneous breathing(SB) without pressure support ventilation (PSV) under laryngeal mask airway (LMA).

General anesthesia across LMA under SB without PSV

Procedure: general anesthesia across LMA
general anesthesia across LMA

Procedure: Spontaneous breathing(SB)
general anesthesia across LMA under SB without PSV

Active Comparator: Group PSV
General anesthesia across LMA under SB with PSV Patient is scheduled for elective conisation or hysteroscopy under general anesthesia. The ventilation mode for this group is SB with PSV under LMA.
Procedure: general anesthesia across LMA
general anesthesia across LMA

Procedure: Spontaneous breathing(SB)
general anesthesia across LMA under SB without PSV

Procedure: Pressure Support Ventilation
general anesthesia across LMA under SB with PSV




Primary Outcome Measures :
  1. Perioperative changes in ventilation inhomogeneity (LCI) [ Time Frame: Through study completion, an average of 12 hours ]
    LCI will be derived from the nitrogen multiple breath washout technique that will be applied before and after general anesthesia for gynecology in the lithotomy position with patients breathing spontaneously through a LMA with and without pressure support.


Secondary Outcome Measures :
  1. Alterations in end expiratory lung volume in ml/kg (EELV) [ Time Frame: Through study completion, an average of 12 hours ]
    EELV will be measured from the nitrogen multiple breath washout technique that will be applied before and after general anesthesia for gynecology in the lithotomy position with patients breathing spontaneously through a LMA with and without pressure support.

  2. Changes in respiratory system compliance (Crs) [ Time Frame: Through study completion, an average of 12 hours ]
    Crs will be measured by the forced oscillation technique

  3. Changes in airway resistance (Raw) [ Time Frame: Through study completion, an average of 12 hours ]
    Raw will be measured by the forced oscillation technique

  4. Perioperative respiratory complications [ Time Frame: Through study completion, an average of 12 hours ]
    any respiratory complications (apnoea/ bradypnoea, bronchospasm, laryngospasm, oxygen desaturation <90%/ hypoxemia, hypoventilation/ atelectasis, pulmonary embolism, cough and /or airway obstruction



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

- American Society of Anesthesiologists physical status (ASA) Ⅰ and Ⅱ grade, adult female patients, aged between 18 and 50 years scheduled for elective gynecological surgery in the lithotomy position.

Exclusion Criteria:

  1. Age<18 years and >50 years old
  2. ASA score of III-V
  3. Patients with a potentially difficult airway (cervical spine disease, Mallampati classification III or IV or mouth opening of <2.5 cm)
  4. Risk of regurgitation/aspiration(previous upper gastrointestinal tract surgery, known or symptomatic hiatus hernia, oesophageal reflux, peptic ulceration or not fasted)
  5. Respiratory diseases(bronchial asthma requiring therapy)
  6. Patient refusal
  7. Malignant hyperthermia history
  8. Sore throat within 10 days
  9. Body mass index (BMI) >30 kg/m2
  10. Cardiac disease associated with dyspnea more than New York Heart Association II
  11. Severe psychiatric disorder.

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): NCT02986269


Contacts
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Contact: Walid HABRE, MD,PhD +4122 37 27 504 walid.habre@hcuge.ch

Locations
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Switzerland
University Hospitals of Geneva Recruiting
Geneva, Switzerland, 1206
Contact: Walid Habre, MD, PhD    +41 22 37 27 504    walid.habre@hcuge.ch   
Contact: NA LIN, MD,PhD    +41 77 98 04 534 ext LIN    na.lin@etu.unige.ch   
Sponsors and Collaborators
Walid HABRE
Investigators
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Principal Investigator: Walid HABRE, MD,PhD University Hospitals of Geneva
Publications of Results:

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Responsible Party: Walid HABRE, Anesthesiology, University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT02986269    
Other Study ID Numbers: VINHO
First Posted: December 8, 2016    Key Record Dates
Last Update Posted: January 6, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Walid HABRE, University Hospital, Geneva:
Respiratory Function
Patient Positioning
anesthesia
Additional relevant MeSH terms:
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Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs