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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| general anesthesia across LMA | Procedure | general anesthesia across LMA |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
- American Society of Anesthesiologists physical status (ASA) â… and â…¡ grade, adult female patients, aged between 18 and 50 years scheduled for elective gynecological surgery in the lithotomy position.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Walid HABRE, MD,PhD | University Hospitals of Geneva | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals of Geneva | Geneva | 1206 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21062790 | Result | 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. | |
| 1914057 | 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. |
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| ID | Term |
|---|---|
| D053120 | Respiratory Aspiration |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Spontaneous breathing(SB) | Procedure | general anesthesia across LMA under SB without PSV |
|
| Pressure Support Ventilation | Procedure | general anesthesia across LMA under SB with PSV |
|
| Changes in respiratory system compliance (Crs) | Crs will be measured by the forced oscillation technique | Through study completion, an average of 12 hours |
| Changes in airway resistance (Raw) | Raw will be measured by the forced oscillation technique | Through study completion, an average of 12 hours |
| 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 |
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| 16119601 | 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. |
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| 37923301 | Derived | 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. |