PSV on Ventilation Inhomogeneity and Lung Function in Patients Under SB Across LMA
NCT ID: NCT02986269
Last Updated: 2022-02-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
40 participants
INTERVENTIONAL
2018-04-13
2021-09-16
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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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
general anesthesia across LMA
general anesthesia across LMA
Spontaneous breathing(SB)
general anesthesia across LMA under SB without PSV
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.
general anesthesia across LMA
general anesthesia across LMA
Spontaneous breathing(SB)
general anesthesia across LMA under SB without PSV
Pressure Support Ventilation
general anesthesia across LMA under SB with PSV
Interventions
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general anesthesia across LMA
general anesthesia across LMA
Spontaneous breathing(SB)
general anesthesia across LMA under SB without PSV
Pressure Support Ventilation
general anesthesia across LMA under SB with PSV
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
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.
18 Years
50 Years
FEMALE
No
Sponsors
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Walid HABRE
OTHER
Responsible Party
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Walid HABRE
Anesthesiology
Principal Investigators
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Walid HABRE, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospitals of Geneva
Locations
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University Hospitals of Geneva
Geneva, , Switzerland
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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VINHO
Identifier Type: -
Identifier Source: org_study_id
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