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

NCT02986269 | Completed

• 1 other identifier: VINHO
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Function Tests; Anesthesia, General; Patient Positioning; Ventilation

Keywords

Respiratory Function; Patient Positioning; anesthesia

Outcome Measures

Primary Outcomes (1)

• Perioperative changes in ventilation inhomogeneity (LCI)

  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 Outcomes (4)

• Alterations in end expiratory lung volume in ml/kg (EELV)

  Through study completion, an average of 12 hours

• Changes in respiratory system compliance (Crs)

  Through study completion, an average of 12 hours

• Changes in airway resistance (Raw)

  Through study completion, an average of 12 hours

• Perioperative respiratory complications

  Through study completion, an average of 12 hours

Study Arms (2)

Group SB

EXPERIMENTAL

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; Procedure: Spontaneous breathing(SB)

Group PSV

ACTIVE COMPARATOR

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; Procedure: Spontaneous breathing(SB); Procedure: Pressure Support Ventilation

Interventions

general anesthesia across LMA PROCEDURE

general anesthesia across LMA

Group PSV; Group SB

Spontaneous breathing(SB) PROCEDURE

general anesthesia across LMA under SB without PSV

Group PSV; Group SB

Pressure Support Ventilation PROCEDURE

general anesthesia across LMA under SB with PSV

Group PSV

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \- 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Walid HABRE: lead

Study Sites (1)

University Hospitals of Geneva

Geneva, 1206, Switzerland

Location

Related Publications (17)

• Tiefenthaler W, Pehboeck D, Hammerle E, Kavakebi P, Benzer A. Lung function after total intravenous anaesthesia or balanced anaesthesia with sevoflurane. Br J Anaesth. 2011 Feb;106(2):272-6. doi: 10.1093/bja/aeq321. Epub 2010 Nov 9.

  PMID: 21062790 RESULT

• Daley MD, Norman PH, Colmenares ME, Sandler AN. Hypoxaemia in adults in the post-anaesthesia care unit. Can J Anaesth. 1991 Sep;38(6):740-6. doi: 10.1007/BF03008452.

  PMID: 1914057 RESULT

• von Ungern-Sternberg BS, Regli A, Schneider MC, Kunz F, Reber A. Effect of obesity and site of surgery on perioperative lung volumes. Br J Anaesth. 2004 Feb;92(2):202-7. doi: 10.1093/bja/aeh046.

  PMID: 14722169 RESULT

• Grocott HP. From the Journal archives: Airway closure and lung volumes in surgical positions. Can J Anaesth. 2014 Apr;61(4):383-6. doi: 10.1007/s12630-013-0098-1. Epub 2014 Jan 18.

  PMID: 24442988 RESULT

• Reber A, Bein T, Hogman M, Khan ZP, Nilsson S, Hedenstierna G. Lung aeration and pulmonary gas exchange during lumbar epidural anaesthesia and in the lithotomy position in elderly patients. Anaesthesia. 1998 Sep;53(9):854-61. doi: 10.1046/j.1365-2044.1998.00491.x.

  PMID: 9849278 RESULT

• Brain AI. The laryngeal mask--a new concept in airway management. Br J Anaesth. 1983 Aug;55(8):801-5. doi: 10.1093/bja/55.8.801.

  PMID: 6349667 RESULT

• Keller C, Brimacombe J. [Spontaneous versus controlled respiration with the laryngeal mask. A review]. Anaesthesist. 2001 Mar;50(3):187-91. doi: 10.1007/s001010050987. German.

  PMID: 11315492 RESULT

• Keller C, Sparr HJ, Brimacombe JR. Positive pressure ventilation with the laryngeal mask airway in non-paralysed patients: comparison of sevoflurane and propofol maintenance techniques. Br J Anaesth. 1998 Mar;80(3):332-6. doi: 10.1093/bja/80.3.332.

  PMID: 9623433 RESULT

• Radhika KS, Sripriya R, Ravishankar M, Hemanth Kumar VR, Jaya V, Parthasarathy S. Assessment of suitability of i-gel and laryngeal mask airway-supreme for controlled ventilation in anesthetized paralyzed patients: A prospective randomized trial. Anesth Essays Res. 2016 Jan-Apr;10(1):88-93. doi: 10.4103/0259-1162.167849.

  PMID: 26957697 RESULT

• Sharma R, Dua CK, Saxena KN. A randomised controlled study comparing the effects of laryngeal mask airway and endotracheal tube on early postoperative pulmonary functions. Singapore Med J. 2011 Dec;52(12):874-8.

  PMID: 22159929 RESULT

• Capdevila X, Jung B, Bernard N, Dadure C, Biboulet P, Jaber S. Effects of pressure support ventilation mode on emergence time and intra-operative ventilatory function: a randomized controlled trial. PLoS One. 2014 Dec 23;9(12):e115139. doi: 10.1371/journal.pone.0115139. eCollection 2014.

  PMID: 25536515 RESULT

• Keller C, Brimacombe J, Hoermann C, Loeckinger A, Kleinsasser A. Pressure support ventilation with the ProSeal laryngeal mask airway. A comparison of sevoflurane, isoflurane and propofol. Eur J Anaesthesiol. 2005 Aug;22(8):630-3. doi: 10.1017/s0265021505001055.

  PMID: 16119601 RESULT

• Chiumello D, Pelosi P, Calvi E, Bigatello LM, Gattinoni L. Different modes of assisted ventilation in patients with acute respiratory failure. Eur Respir J. 2002 Oct;20(4):925-33. doi: 10.1183/09031936.02.01552001.

  PMID: 12412685 RESULT

• von Ungern-Sternberg BS, Regli A, Frei FJ, Hammer J, Schibler A, Erb TO. The effect of caudal block on functional residual capacity and ventilation homogeneity in healthy children. Anaesthesia. 2006 Aug;61(8):758-63. doi: 10.1111/j.1365-2044.2006.04720.x.

  PMID: 16867088 RESULT

• Singer F, Houltz B, Latzin P, Robinson P, Gustafsson P. A realistic validation study of a new nitrogen multiple-breath washout system. PLoS One. 2012;7(4):e36083. doi: 10.1371/journal.pone.0036083. Epub 2012 Apr 27.

  PMID: 22558338 RESULT

• Robinson PD, Goldman MD, Gustafsson PM. Inert gas washout: theoretical background and clinical utility in respiratory disease. Respiration. 2009;78(3):339-55. doi: 10.1159/000225373. Epub 2009 Jun 12.

  PMID: 19521061 RESULT

• Sudy R, Dereu D, Lin N, Pichon I, Petak F, Habre W, Albu G. Respiratory effects of pressure support ventilation in spontaneously breathing patients under anaesthesia: Randomised controlled trial. Acta Anaesthesiol Scand. 2024 Mar;68(3):311-320. doi: 10.1111/aas.14350. Epub 2023 Nov 3.

  PMID: 37923301 DERIVED

MeSH Terms

Conditions

Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Walid HABRE, MD,PhD

  University Hospitals of Geneva

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Anesthesiology

Study Record Dates

• First Submitted: November 25, 2016
• First Posted: December 8, 2016
• Study Start: April 13, 2018
• Primary Completion: September 16, 2021
• Study Completion: September 16, 2021
• Last Updated: February 28, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)