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

February 25, 2022 updated by: Walid HABRE

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Geneva, Switzerland, 1206
        • University Hospitals of Geneva

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Through study completion, an average of 12 hours

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Walid HABRE

Investigators

  • Principal Investigator: Walid HABRE, MD,PhD, University Hospitals of Geneva

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 13, 2018

Primary Completion (Actual)

September 16, 2021

Study Completion (Actual)

September 16, 2021

Study Registration Dates

First Submitted

November 25, 2016

First Submitted That Met QC Criteria

December 5, 2016

First Posted (Estimate)

December 8, 2016

Study Record Updates

Last Update Posted (Actual)

February 28, 2022

Last Update Submitted That Met QC Criteria

February 25, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VINHO

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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