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

Anesthesia, General Clinical Trial

— VINHO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02986269
• Other study ID #: VINHO
• Status: Completed
• Phase: N/A
• Start date: April 13, 2018
• Est. completion date: September 16, 2021

Study information

• Verified date: February 2022
• Source: University Hospital, Geneva
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

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

Intervention

Procedure:
• 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

Locations

Country	Name	City	State
Switzerland	University Hospitals of Geneva	Geneva

Sponsors (1)

Lead Sponsor	Collaborator
Walid HABRE

Country where clinical trial is conducted

Switzerland, 

References & Publications (16)

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

Outcome

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