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Completed

NCT Number: NCT02986269

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

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.

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Key information

Conditions

Respiratory Function Tests Anesthesia, General Pathologic Processes Pathological Conditions, Signs and Symptoms Patient Positioning Respiration Disorders Respiratory Aspiration Respiratory Tract Diseases Ventilation

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University Hospitals of Geneva

Geneva, 1206, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

general anesthesia across LMA

Procedure

general anesthesia across LMA

Spontaneous breathing(SB)

Procedure

general anesthesia across LMA under SB without PSV

pressure support ventilation

Procedure

general anesthesia across LMA under SB with PSV

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Walid HABRE

Other

Registry information

Official study title

The Value of Pressure Support on Ventilation Inhomogeneity and Lung Function in Patients Under Spontaneous Breathing (SB)Across Laryngeal Mask Airway

Acronym: VINHO

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Dec 8, 2016
Registry last updated
Feb 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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