Ignite Creation Date:
2024-05-06 @ 3:16 AM
Last Modification Date:
2024-10-26 @ 11:30 AM
Study NCT ID:
NCT02240901
Status:
COMPLETED
Last Update Posted:
2020-10-29
First Post:
2014-08-23
Brief Title:
A Multi-center Randomized Clinical Trial About Using LMA or ETI in Elderly Patients
Sponsor:
RenJi Hospital
Organization:
RenJi Hospital
Study Overview
Official Title:
Effectiveness and Pulmonary Complications of Peri-Operative Laryngeal Mask Airway Used in Elderly PatientsPOLMA-EP Trial a Multi-center Randomized Controlled Clinical Trial
Status:
COMPLETED
Status Verified Date:
2020-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LMAETI
Brief Summary:
Perioperative airway management is a top priority of anesthesiologists in daily work and endotracheal intubation ETI is considered as the gold standard for providing safe glottic sealeffective ventilation and oxygen supplement during general anesthesia But ETI related complications such as concomitant hemodynamic responses damage to the oropharyngeal structures at insertion and postoperative sore throat Laryngeal mask airwayLMA for the anesthesia management brings new choice with invasive lighter cardiovascular reaction and many other advantages particularly suited to short and minimally invasive surgery But LMA increased the risk of gastrointestinal reflux aspiration than using ETI and it may resulted in intolerance in high airway pressure especially in elderly patients with increased lung compliance or reduced airway resistance Furthermore LMA could not entirely prevent the occurrence of postoperative sore throat and hoarse
To sum up it is necessary to carry out a multicenter clinical trial to clarify the safety of LMA in elderly patients The investigators protocol will focus on the incidence of postoperative pulmonary complications PPCs when applications of LMA and ETI in elderly patients
To sum up it is necessary to carry out a multicenter clinical trial to clarify the safety of LMA in elderly patients The investigators protocol will focus on the incidence of postoperative pulmonary complications PPCs when applications of LMA and ETI in elderly patients
Detailed Description:
1 Introduction 11 Background It is essential for peri-operative patients to ensure airway patency and effective ventilation and respiratory is the most important task in anesthesiologists daily work Endotracheal intubationETI is the gold standard for maintenance patients ventilation in general anesthesia It can effectively send narcotic gas into the trachea and allow oxygen ventilation well controlled However ETI-related complications such as dental and oral soft tissue injury intubation and extubation related cardiovascular reactions hinder its application in some special populations such as elderly patients Clinical application of laryngeal mask airway LMA has brought new options and new ideas for anesthesia management LMA has the advantage of light damage small trauma simple operation and minor cardiovascular response and it is especially suitable for airway control of patient in short and minimally invasive operation In recent years the application of LMA has a greater proportion compared with ETI in some areas But with LMA application increasing more and more problems have been reported
LMA has a greater risk of gastrointestinal reflux and aspiration because of its inadequate airway tightness For the same reason LMA is of intolerance to high airway pressure and this may lead to hypoventilation in elderly patients with lung compliance or increased airway resistance At the same time the LMA cant completely prevent incidence of postoperative sore throat and hoarseness Therefore it is necessary to carry out a multi-center clinical trial to clarify the peri-operative advantages and disadvantages of LMA to elderly patients to preliminary explore the LMA complications occurred in elderly patients using predictive models and to clarify the safety of the LMA in airway support of elderly patients
12 Research Aims The aim of the present research is to study the effects of LMA compared with conventional ETI on elderly patients considering postoperative pulmonary complications anesthesia and recovery quality oxygenation and airway support related complications
13 Primary endpoint events Postoperative pulmonary complications before discharge 14 Secondary endpoint events and other pre-specified outcomes 141 Mortality 142 PACU stay 143 Hospiitalization cost and duration 144 ICU admission and stay time patients who meet the ICU inclusion criteria are admitted into ICU those who are admitted into ICU because of bed conversion are excluded and those who should have been out of ICU are also excluded 145 Treatment for PPCs 146 Blood and sputum culture
LMA has a greater risk of gastrointestinal reflux and aspiration because of its inadequate airway tightness For the same reason LMA is of intolerance to high airway pressure and this may lead to hypoventilation in elderly patients with lung compliance or increased airway resistance At the same time the LMA cant completely prevent incidence of postoperative sore throat and hoarseness Therefore it is necessary to carry out a multi-center clinical trial to clarify the peri-operative advantages and disadvantages of LMA to elderly patients to preliminary explore the LMA complications occurred in elderly patients using predictive models and to clarify the safety of the LMA in airway support of elderly patients
12 Research Aims The aim of the present research is to study the effects of LMA compared with conventional ETI on elderly patients considering postoperative pulmonary complications anesthesia and recovery quality oxygenation and airway support related complications
13 Primary endpoint events Postoperative pulmonary complications before discharge 14 Secondary endpoint events and other pre-specified outcomes 141 Mortality 142 PACU stay 143 Hospiitalization cost and duration 144 ICU admission and stay time patients who meet the ICU inclusion criteria are admitted into ICU those who are admitted into ICU because of bed conversion are excluded and those who should have been out of ICU are also excluded 145 Treatment for PPCs 146 Blood and sputum culture
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EHBHKY20I3-003-005 | OTHER | EHBH | None |