An interventional study of Laryngeal mask airway（LMA） and Endotracheal intubation（ETI） in Complications and Surgery, sponsored by RenJi Hospital. Completed at 1 site in China. Open to participants aged 70 Years and older. Per ClinicalTrials.gov, last updated 2020-10-29.
Sponsored by RenJi Hospital · Not applicable, Interventional, and Treatment
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 seal,effective 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 airway(LMA) 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.
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 can't 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.
1.2 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.
1.3 Primary endpoint events Postoperative pulmonary complications before discharge. 1.4 Secondary endpoint events and other pre-specified outcomes 1.4.1 Mortality 1.4.2 PACU stay 1.4.3 Hospiitalization cost and duration 1.4.4 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) 1.4.5 Treatment for PPCs 1.4.6 Blood and sputum culture
RenJi Hospital is the lead sponsor of 535 studies on the registry; 244 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Laryngeal mask airway（LMA） is used to maintain mechanical ventilation during intra-operative
Device: Laryngeal mask airway（LMA）
Endotracheal intubation group（ETI）is used to maintain mechanical ventilation during intra-operative
Device: Endotracheal intubation（ETI）
Laryngeal mask airway（LMA） is used to maintain mechanical ventilation during intra-operative
Endotracheal intubation group（ETI）is used to maintain mechanical ventilation during intra-operative
The occurrence of postoperative pulmonary complications
five-category scale to assess the pulmonary outcomes: 0, no pulmonary complications 1, either one of the following: cough, minor lung atelectasis, dyspnea; 2, cough and sputum, bronchospasm, hypoxemia, atelectasis, hypercapnia; 3, pleural effusion, suspected pneumonia, diagnosed pneumonia, pneumothorax, diagnosed pneumonia, pneumothorax, non-invasive or invasive mechanical ventilation\<48hr 4, respiratory failure.
Time frame: before discharge
mortality
Time frame: before discharge
ICU admission rate
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
Time frame: before discharge
Hospitalization days
Time frame: before discharge
PACU stay
PACU stay time collection is based on anesthesia records
Time frame: before discharge
Blood and sputum culture
In-hospital medical examinations and tests will be collected
Time frame: before discharge
Treatment for PPCs
Included antibiotics, anti-sputum drugs, steroids, mechanical ventilation
Time frame: before discharge
ICU stay
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
Time frame: before discharge
Hospiitalization cost
Hospitalization cost is collected from hospital bill, regardless of patient's insurerance coverage
Time frame: before discharge
This study is completed, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.
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RenJi Hospital