Anesthesia, General Clinical Trial
— VINHOOfficial title:
The Value of Pressure Support on Ventilation Inhomogeneity and Lung Function in Patients Under Spontaneous Breathing (SB)Across Laryngeal Mask Airway
NCT number | NCT02986269 |
Other study ID # | VINHO |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | April 13, 2018 |
Est. completion date | September 16, 2021 |
Verified date | February 2022 |
Source | University Hospital, Geneva |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 40 |
Est. completion date | September 16, 2021 |
Est. primary completion date | September 16, 2021 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 50 Years |
Eligibility | Inclusion Criteria: - American Society of Anesthesiologists physical status (ASA) ? and ? 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. |
Country | Name | City | State |
---|---|---|---|
Switzerland | University Hospitals of Geneva | Geneva |
Lead Sponsor | Collaborator |
---|---|
Walid HABRE |
Switzerland,
Brain AI. The laryngeal mask--a new concept in airway management. Br J Anaesth. 1983 Aug;55(8):801-5. — View Citation
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/journa — View Citation
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. — View Citation
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. Review. — View Citation
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. — View Citation
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. — View Citation
Keller C, Brimacombe J. [Spontaneous versus controlled respiration with the laryngeal mask. A review]. Anaesthesist. 2001 Mar;50(3):187-91. Review. German. — View Citation
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. — View Citation
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 Es — View Citation
Reber A, Bein T, Högman 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. — View Citation
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. Review. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
* Note: There are 16 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Alterations in end expiratory lung volume in ml/kg (EELV) | 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 | |
Secondary | Changes in respiratory system compliance (Crs) | Crs will be measured by the forced oscillation technique | Through study completion, an average of 12 hours | |
Secondary | Changes in airway resistance (Raw) | Raw will be measured by the forced oscillation technique | Through study completion, an average of 12 hours | |
Secondary | Perioperative respiratory complications | 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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06063798 -
Respiratory Effects of Flow-Controlled Ventilation and Jet Ventilation in Patients Undergoing Laryngotracheal Surgery
|
N/A | |
Not yet recruiting |
NCT05035069 -
Efficacy and Safety of Ciprofol Compared to Propofol for Nonintubated General Anesthesia in Patients Undergoing TAVR
|
Phase 4 | |
Completed |
NCT03861364 -
Hemodynamics During Induction of General Anesthesia With High and Low Propofol Dose.
|
Phase 4 | |
Completed |
NCT02711280 -
The Effect of Anesthetics on Oxidative Stress and Apoptosis Status in Children
|
N/A | |
Completed |
NCT01199471 -
Estimate the Behavior of Chinese Anesthesiologists Practicing General Anesthesia With Sevoflurane
|
N/A | |
Completed |
NCT00917033 -
Tracheal Intubation of Morbidly Obese Patients. GlideScope Versus Direct Laryngoscopy
|
Phase 4 | |
Completed |
NCT00391885 -
Target-controlled Infusion of Propofol and Remifentanil During General Anaesthesia Guided by Entropy
|
Phase 4 | |
Completed |
NCT00552617 -
A Bridging Trial Comparing Sugammadex (Org 25969) at Reappearance of T2 in Japanese and Caucasian Participants. Part B: Caucasian Participants (P05971)
|
Phase 2 | |
Completed |
NCT03705026 -
Relationship Between Genetic Polymorphism and Postoperative Nausea and Vomiting in Chinese Han Population
|
||
Completed |
NCT00552929 -
A Bridging Trial Comparing Sugammadex (Org 25969) at 1-2 Post-Tetanic Count (PTC) in Caucasian Participants. Part B (P05974)
|
Phase 2 | |
Completed |
NCT00475215 -
Safety and Efficacy of Sugammadex (Org 25969, MK-8616) in Participants With or Having a Past History of Pulmonary Disease (19.4.308) (P05932) (MK-8616-017)
|
Phase 3 | |
Completed |
NCT00298831 -
Use of Sugammadex at the End of Case in Routine Anesthesia (MK-8616-023)
|
Phase 3 | |
Recruiting |
NCT03943745 -
EEG Changes During Induction of Propofol Anesthesia
|
||
Completed |
NCT03697642 -
Nasopharyngeal Airway Guide Nasogastric Tube Placement
|
N/A | |
Completed |
NCT04595591 -
Observation of Propofol Titration at Different Speeds
|
N/A | |
Not yet recruiting |
NCT05841316 -
The ED95 Dose of Sugammadex to Reverse Rocuronium-Induced Deep Neuromuscular Block Back to Shallow Neuromuscular Block
|
||
Completed |
NCT04532502 -
Impact of Anesthetic Environment the Sex Ratio of the Children of Female Assistants
|
||
Completed |
NCT03330236 -
EEG - Guided Anesthetic Care and Postoperative Delirium
|
N/A | |
Recruiting |
NCT06205212 -
High-flow Nasal Oxygenation During Preoxygenation and Atelectasis
|
N/A | |
Completed |
NCT00379613 -
Use of Sugammadex Administered at 5 Minutes After Administration of 1.2 mg/kg Esmeron® (19.4.205)(P05942)
|
Phase 2 |