Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06589011
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-09-05
Brief Title:
Postoperative Hypoxemia in Obese Patients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Postoperative Hypoxemia in Obese Patients Pressure Support Versus Spontaneous Ventilation During Anesthetic Emergence in Laparoscopic Bariatric Surgery A Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RCT
Brief Summary:
Postoperative atelectasis can cause postoperative hypoxia which might be avoided by applying pressure support during extubation of obese patients undergoing bariatric surgeries
Detailed Description:
Postoperative atelectasis is one of the most common pulmonary complications in surgical patients and a fair majority of studies have suggested that postoperative atelectasis is harmful It increases the risk of hypoxemia and forms the pathophysiologic basis for other postoperative pulmonary complications Atelectasis can last for several days after surgery impairing respiratory function and ultimately delaying patient discharge
Obese patients are more likely than non-obese patients to develop atelectasis that resolves more slowly This is because of a marked impairment of the respiratory mechanics decreased chest wall and lung compliance and decreased functional residual capacity promoting airway closure with reduction of the oxygenation index Pao2 PAo2 to a greater extent than in healthy-weight subjects Also the weight of the abdomen makes diaphragmatic excursions more difficult especially when recumbent or supine which is intensified in the setting of diaphragmatic paralysis associated with neuromuscular blockade
Although there have been many studies regarding ventilatory techniques to reduce postoperative pulmonary complications only a few studies have focused on the period of recovery from anesthesia The benefits obtained from the protective ventilation techniques may be lost during this emergence process Whalen et al found that recruitment maneuver and the application of positive end-expiratory pressure PEEP improved intraoperative oxygenation but the effect dissipated promptly after extubation Many studies have observed the development of atelectasis during the emergence period Furthermore it is estimated that the emergence period contributes to approximately 39 of the total amount of postoperative atelectasis
Currently we allow patients to breathe spontaneously and assist their respiration intermittently during the transition from controlled ventilation to spontaneous respiration while assessing whether the patients have enough power to breathe without assistance However patients who are spontaneously breathing remain under the influence of residual anesthetic agents and neuromuscular blockers and may not have restored their functional residual capacity subsequently developing atelectasis In addition pain-induced respiratory restriction or respiratory muscle fatigue during spontaneous respiration may increase the risk of atelectasis
Pressure support ventilation is widely used for weaning from mechanical ventilation in the intensive care unit ICU and is recently available in anesthesia machines Pressure support ventilation applies a fixed amount of pressure the physician selects to the patients throughout each breath to augment their own respiration and is one of the most comfortable ventilation modes for patients In these aspects pressure support ventilation during recovery from anesthesia may reduce postoperative atelectasis compared to spontaneous respiration with intermittent manual assistance To date few studies have assessed the effect of pressure support ventilation on postoperative atelectasis
Moreover laparoscopic surgery are associated with a higher risk of postoperative atelectasis due to the high intra-abdominal pressure which pushes the diaphragm upward and subsequently results in the collapse of the alveoli
Our hypothesis is that pressure support ventilation will reduces the postoperative hypoxemia and atelectasis compared to spontaneous respiration with intermittent manual assistance during anesthetic emergence in obese patients undergoing laparoscopic surgery
Aim of the study
The aim of our study is to assess the possible superiority of pressure support ventilation compared to spontaneous respiration with intermittent manual assistance to reduce postoperative hypoxemia and atelectasis during anesthetic emergence in obese patients undergoing laparoscopic surgery
Obese patients are more likely than non-obese patients to develop atelectasis that resolves more slowly This is because of a marked impairment of the respiratory mechanics decreased chest wall and lung compliance and decreased functional residual capacity promoting airway closure with reduction of the oxygenation index Pao2 PAo2 to a greater extent than in healthy-weight subjects Also the weight of the abdomen makes diaphragmatic excursions more difficult especially when recumbent or supine which is intensified in the setting of diaphragmatic paralysis associated with neuromuscular blockade
Although there have been many studies regarding ventilatory techniques to reduce postoperative pulmonary complications only a few studies have focused on the period of recovery from anesthesia The benefits obtained from the protective ventilation techniques may be lost during this emergence process Whalen et al found that recruitment maneuver and the application of positive end-expiratory pressure PEEP improved intraoperative oxygenation but the effect dissipated promptly after extubation Many studies have observed the development of atelectasis during the emergence period Furthermore it is estimated that the emergence period contributes to approximately 39 of the total amount of postoperative atelectasis
Currently we allow patients to breathe spontaneously and assist their respiration intermittently during the transition from controlled ventilation to spontaneous respiration while assessing whether the patients have enough power to breathe without assistance However patients who are spontaneously breathing remain under the influence of residual anesthetic agents and neuromuscular blockers and may not have restored their functional residual capacity subsequently developing atelectasis In addition pain-induced respiratory restriction or respiratory muscle fatigue during spontaneous respiration may increase the risk of atelectasis
Pressure support ventilation is widely used for weaning from mechanical ventilation in the intensive care unit ICU and is recently available in anesthesia machines Pressure support ventilation applies a fixed amount of pressure the physician selects to the patients throughout each breath to augment their own respiration and is one of the most comfortable ventilation modes for patients In these aspects pressure support ventilation during recovery from anesthesia may reduce postoperative atelectasis compared to spontaneous respiration with intermittent manual assistance To date few studies have assessed the effect of pressure support ventilation on postoperative atelectasis
Moreover laparoscopic surgery are associated with a higher risk of postoperative atelectasis due to the high intra-abdominal pressure which pushes the diaphragm upward and subsequently results in the collapse of the alveoli
Our hypothesis is that pressure support ventilation will reduces the postoperative hypoxemia and atelectasis compared to spontaneous respiration with intermittent manual assistance during anesthetic emergence in obese patients undergoing laparoscopic surgery
Aim of the study
The aim of our study is to assess the possible superiority of pressure support ventilation compared to spontaneous respiration with intermittent manual assistance to reduce postoperative hypoxemia and atelectasis during anesthetic emergence in obese patients undergoing laparoscopic surgery
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None