ComplicationsLMA;ETINCT02240901
A Multi-center Randomized Clinical Trial About Using LMA or ETI in Elderly Patients
A study testing Laryngeal mask airway（LMA） and Endotracheal intubation（ETI） in people with Complications and Surgery, run by RenJi Hospital at 1 site in China.
Trial 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 seal,effective ventilation and oxygen supplement during general anesthesia. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Complications, Surgery
- What is being tested?
- Laryngeal mask airway（LMA） and Endotracheal intubation（ETI）
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,900 participants
- Where
- 1 siteChina
- Study dates
- 3 Aug 2016to 15 Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age ≥ 70
- Elective surgery
- BMI ≤ 35 kg/m2
- Provision of signed informed consent
Who cannot join
- emergency surgery
- have anticipated difficult intubation
- have a broken or unstable cervix
- have laryngeal disease
- are at high risk of aspiration (gastroesophageal reflux disease, full stomach)
- are unable to cooperate for any reason, such as inability to speak or understand, mental disease, or inability to go to the clinics
Show all 9Show fewer
- have taken experimental drugs in the preceding 3 months or joined another clinical trial
- did not provide informed consent or have withdrawn consent
- are evaluated by the investigator as unsuitable for this trial
Trial locations and contacts
1 site in 1 country.
China1 site
Renji Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, 200127
About this study
Official title: Effectiveness and Pulmonary Complications of Peri-Operative Laryngeal Mask Airway Used in Elderly Patients(POLMA-EP Trial): a Multi-center Randomized Controlled Clinical Trial
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.
Read the detailed description
- Introduction 1.1 Background It is essential for peri-operative patients to ensure airway patency and effective ventilation, and respiratory is the most important task in anesthesiologist's daily work. Endotracheal intubation(ETI) 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 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
- Conditions
- Complications, Surgery
- Being tested
- Laryngeal mask airway（LMA）, Endotracheal intubation（ETI）
- Keywords
- Laryngeal mask airway, endotracheal intubation, postoperative pulmonary complications, elderly patients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laryngeal mask airway（LMA）Device
Laryngeal mask airway（LMA） is used to maintain mechanical ventilation during intra-operative
Endotracheal intubation（ETI）Device
Endotracheal intubation group（ETI）is used to maintain mechanical ventilation during intra-operative
| Study group | Role | What they receive |
|---|---|---|
| Laryngeal mask airway | Experimental | Laryngeal mask airway（LMA） is used to maintain mechanical ventilation during intra-operative Receives: Device: Laryngeal mask airway（LMA） |
| Endotracheal intubation group（ETI） | Experimental | Endotracheal intubation group（ETI）is used to maintain mechanical ventilation during intra-operative Receives: Device: Endotracheal intubation（ETI） |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: before discharge
Secondary outcomes (8)
mortality
Measured: 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
Measured: before discharge
Hospitalization days
Measured: before discharge
PACU stay
PACU stay time collection is based on anesthesia records
Measured: before discharge
Blood and sputum culture
In-hospital medical examinations and tests will be collected
Measured: before discharge
Treatment for PPCs
Included antibiotics, anti-sputum drugs, steroids, mechanical ventilation
Measured: 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
Measured: before discharge
Hospiitalization cost
Hospitalization cost is collected from hospital bill, regardless of patient's insurerance coverage
Measured: before discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2014 (estimated)
- Study start3 Aug 2016
- Primary completion23 Jan 2020
- Study completion15 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 2,900 participants (actual)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Fudan University, Shanghai Changzheng Hospital, Shanghai First Maternity and Infant Hospital, Huadong Hospital, West China Hospital, Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai Jiading District Central Hospital, Shanghai Pudong New Area Gongli Hospital, Shanghai Huangpu District Central Hospital, Shanghai Fengxian District Central Hospital, People's Hospital of Pudong New District, First Affiliated Hospital of Wenzhou Medical University, Wuxi No. 2 People's Hospital, The First Affiliated Hospital of Xiamen University
- Responsible party
- Principal investigator, LiqunYang, RenJi Hospital
- Investigators
- Weifeng Yu, Ph.D., Study chair, Department of Anesthesiology Renji Hospital, Shanghai Jiaotong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02240901
- Sponsor's protocol ID
- EHBH2013-003-005
- Other IDs
- EHBHKY20I3-003-005
- Acronym
- LMA;ETI
- Status last verified
- Oct 2020
- First submitted
- 23 Aug 2014
- Last updated
- 29 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
Publications
Patel MG, Swadia V, Bansal G. Prospective randomized comparative study of use of PLMA and ET tube for airway management in children under general anaesthesia. Indian J Anaesth. 2010 Mar;54(2):109-15. doi: 10.4103/0019-5049.63643.
PubMed 20661347Futier E, Constantin JM, Paugam-Burtz C, Pascal J, Eurin M, Neuschwander A, Marret E, Beaussier M, Gutton C, Lefrant JY, Allaouchiche B, Verzilli D, Leone M, De Jong A, Bazin JE, Pereira B, Jaber S; IMPROVE Study Group. A trial of intraoperative low-tidal-volume ventilation in abdominal surgery. N Engl J Med. 2013 Aug 1;369(5):428-37. doi: 10.1056/NEJMoa1301082.
PubMed 23902482Wang HE, Szydlo D, Stouffer JA, Lin S, Carlson JN, Vaillancourt C, Sears G, Verbeek RP, Fowler R, Idris AH, Koenig K, Christenson J, Minokadeh A, Brandt J, Rea T; ROC Investigators. Endotracheal intubation versus supraglottic airway insertion in out-of-hospital cardiac arrest. Resuscitation. 2012 Sep;83(9):1061-6. doi: 10.1016/j.resuscitation.2012.05.018. Epub 2012 Jun 1.
PubMed 22664746Sharma 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.
PubMed 22159929Avidan MS, Jacobsohn E, Glick D, Burnside BA, Zhang L, Villafranca A, Karl L, Kamal S, Torres B, O'Connor M, Evers AS, Gradwohl S, Lin N, Palanca BJ, Mashour GA; BAG-RECALL Research Group. Prevention of intraoperative awareness in a high-risk surgical population. N Engl J Med. 2011 Aug 18;365(7):591-600. doi: 10.1056/NEJMoa1100403.
PubMed 21848460Lerman J, Hammer GB, Verghese S, Ehlers M, Khalil SN, Betts E, Trillo R, Deutsch J; MAPS Investigators Group. Airway responses to desflurane during maintenance of anesthesia and recovery in children with laryngeal mask airways. Paediatr Anaesth. 2010 Jun;20(6):495-505. doi: 10.1111/j.1460-9592.2010.03305.x. Epub 2010 Apr 23.
PubMed 20456065Ferrari G, Milan A, Groff P, Pagnozzi F, Mazzone M, Molino P, Apra F. Continuous positive airway pressure vs. pressure support ventilation in acute cardiogenic pulmonary edema: a randomized trial. J Emerg Med. 2010 Nov;39(5):676-84. doi: 10.1016/j.jemermed.2009.07.042. Epub 2009 Oct 8.
PubMed 19818574Zoremba M, Aust H, Eberhart L, Braunecker S, Wulf H. Comparison between intubation and the laryngeal mask airway in moderately obese adults. Acta Anaesthesiol Scand. 2009 Apr;53(4):436-42. doi: 10.1111/j.1399-6576.2008.01882.x. Epub 2009 Feb 18.
PubMed 19226293Nava S, Hill N. Non-invasive ventilation in acute respiratory failure. Lancet. 2009 Jul 18;374(9685):250-9. doi: 10.1016/S0140-6736(09)60496-7.
PubMed 19616722Gray AJ, Goodacre S, Newby DE, Masson MA, Sampson F, Dixon S, Crane S, Elliott M, Nicholl J; 3CPO Study Investigators. A multicentre randomised controlled trial of the use of continuous positive airway pressure and non-invasive positive pressure ventilation in the early treatment of patients presenting to the emergency department with severe acute cardiogenic pulmonary oedema: the 3CPO trial. Health Technol Assess. 2009 Jul;13(33):1-106. doi: 10.3310/hta13330.
PubMed 19615296Glerant JC, Rose D, Oltean V, Dayen C, Mayeux I, Jounieaux V. Noninvasive ventilation using a mouthpiece in patients with chronic obstructive pulmonary disease and acute respiratory failure. Respiration. 2007;74(6):632-9. doi: 10.1159/000105163. Epub 2007 Jul 2.
PubMed 17622735Severgnini P, Selmo G, Lanza C, Chiesa A, Frigerio A, Bacuzzi A, Dionigi G, Novario R, Gregoretti C, de Abreu MG, Schultz MJ, Jaber S, Futier E, Chiaranda M, Pelosi P. Protective mechanical ventilation during general anesthesia for open abdominal surgery improves postoperative pulmonary function. Anesthesiology. 2013 Jun;118(6):1307-21. doi: 10.1097/ALN.0b013e31829102de.
PubMed 23542800Biere SS, van Berge Henegouwen MI, Maas KW, Bonavina L, Rosman C, Garcia JR, Gisbertz SS, Klinkenbijl JH, Hollmann MW, de Lange ES, Bonjer HJ, van der Peet DL, Cuesta MA. Minimally invasive versus open oesophagectomy for patients with oesophageal cancer: a multicentre, open-label, randomised controlled trial. Lancet. 2012 May 19;379(9829):1887-92. doi: 10.1016/S0140-6736(12)60516-9. Epub 2012 May 1.
PubMed 22552194Zhu L, Shi X, Yin S, Yin J, Zhu Z, Gao X, Jiao Y, Yu W, Yang L. Effectiveness and pulmonary complications of perioperative laryngeal mask airway used in elderly patients (POLMA-EP trial): study protocol for a randomized controlled trial. Trials. 2019 May 8;20(1):260. doi: 10.1186/s13063-019-3351-2.
PubMed 31068221
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Pulmonary Complications of Peri-Operative Laryngeal Mask Airway Used in Elderly Patients(POLMA-EP Trial): a Multi-center Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT02240901
- Acronym / sponsor ID
- LMA;ETI / EHBH2013-003-005
- Conditions
- Complications, Surgery
- Keywords
- Laryngeal mask airway, endotracheal intubation, postoperative pulmonary complications, elderly patients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,900 participants (actual)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Collaborators
- Fudan University, Shanghai Changzheng Hospital, Shanghai First Maternity and Infant Hospital, Huadong Hospital, West China Hospital, Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai Jiading District Central Hospital, Shanghai Pudong New Area Gongli Hospital, Shanghai Huangpu District Central Hospital, Shanghai Fengxian District Central Hospital, People's Hospital of Pudong New District, First Affiliated Hospital of Wenzhou Medical University, Wuxi No. 2 People's Hospital, The First Affiliated Hospital of Xiamen University
- Study start
- 3 Aug 2016 (actual)
- Primary completion
- 23 Jan 2020 (actual)
- Study completion
- 15 Apr 2020 (actual)
- First posted
- 16 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- Introduction 1.1 Background It is essential for peri-operative patients to ensure airway patency and effective ventilation, and respiratory is the most important task in anesthesiologist's daily work. Endotracheal intubation(ETI) 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 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laryngeal mask airway | Experimental | Device: Laryngeal mask airway（LMA）Laryngeal mask airway（LMA） is used to maintain mechanical ventilation during intra-operative |
| Endotracheal intubation group（ETI） | Experimental | Device: Endotracheal intubation（ETI）Endotracheal intubation group（ETI）is used to maintain mechanical ventilation during intra-operative |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Age ≥ 70
- Elective surgery
- BMI ≤ 35 kg/m2
- Provision of signed informed consent
Key exclusion criteria (9 listed)
- emergency surgery
- have anticipated difficult intubation
- have a broken or unstable cervix
- have laryngeal disease
- are at high risk of aspiration (gastroesophageal reflux disease, full stomach)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laryngeal mask airway（LMA）Laryngeal mask airway（LMA） is used to maintain mechanical ventilation during intra-operative | Device | Laryngeal mask airway |
| Endotracheal intubation（ETI）Endotracheal intubation group（ETI）is used to maintain mechanical ventilation during intra-operative | Device | Endotracheal intubation group（ETI） |
Primary outcome
The occurrence of postoperative pulmonary complications
Time frame: before discharge
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.
8 secondary outcomes
mortality
Time frame: before discharge
ICU admission rate
Time frame: before discharge
Hospitalization days
Time frame: before discharge
PACU stay
Time frame: before discharge
Blood and sputum culture
Time frame: before discharge
Treatment for PPCs
Time frame: before discharge
ICU stay
Time frame: before discharge
Hospiitalization cost
Time frame: before discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2020.
- Background: PubMed 20661347Patel MG, Swadia V, Bansal G. Prospective randomized comparative study of use of PLMA and ET tube for airway management in children under general anaesthesia. Indian J Anaesth. 2010 Mar;54(2):109-15. doi: 10.4103/0019-5049.63643.
- Background: PubMed 23902482Futier E, Constantin JM, Paugam-Burtz C, Pascal J, Eurin M, Neuschwander A, Marret E, Beaussier M, Gutton C, Lefrant JY, Allaouchiche B, Verzilli D, Leone M, De Jong A, Bazin JE, Pereira B, Jaber S; IMPROVE Study Group. A trial of intraoperative low-tidal-volume ventilation in abdominal surgery. N Engl J Med. 2013 Aug 1;369(5):428-37. doi: 10.1056/NEJMoa1301082.
- Background: PubMed 22664746Wang HE, Szydlo D, Stouffer JA, Lin S, Carlson JN, Vaillancourt C, Sears G, Verbeek RP, Fowler R, Idris AH, Koenig K, Christenson J, Minokadeh A, Brandt J, Rea T; ROC Investigators. Endotracheal intubation versus supraglottic airway insertion in out-of-hospital cardiac arrest. Resuscitation. 2012 Sep;83(9):1061-6. doi: 10.1016/j.resuscitation.2012.05.018. Epub 2012 Jun 1.
- Background: PubMed 22159929Sharma 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.
- Background: PubMed 21848460Avidan MS, Jacobsohn E, Glick D, Burnside BA, Zhang L, Villafranca A, Karl L, Kamal S, Torres B, O'Connor M, Evers AS, Gradwohl S, Lin N, Palanca BJ, Mashour GA; BAG-RECALL Research Group. Prevention of intraoperative awareness in a high-risk surgical population. N Engl J Med. 2011 Aug 18;365(7):591-600. doi: 10.1056/NEJMoa1100403.
- Background: PubMed 20456065Lerman J, Hammer GB, Verghese S, Ehlers M, Khalil SN, Betts E, Trillo R, Deutsch J; MAPS Investigators Group. Airway responses to desflurane during maintenance of anesthesia and recovery in children with laryngeal mask airways. Paediatr Anaesth. 2010 Jun;20(6):495-505. doi: 10.1111/j.1460-9592.2010.03305.x. Epub 2010 Apr 23.
- Background: PubMed 19818574Ferrari G, Milan A, Groff P, Pagnozzi F, Mazzone M, Molino P, Apra F. Continuous positive airway pressure vs. pressure support ventilation in acute cardiogenic pulmonary edema: a randomized trial. J Emerg Med. 2010 Nov;39(5):676-84. doi: 10.1016/j.jemermed.2009.07.042. Epub 2009 Oct 8.
- Background: PubMed 19226293Zoremba M, Aust H, Eberhart L, Braunecker S, Wulf H. Comparison between intubation and the laryngeal mask airway in moderately obese adults. Acta Anaesthesiol Scand. 2009 Apr;53(4):436-42. doi: 10.1111/j.1399-6576.2008.01882.x. Epub 2009 Feb 18.
- Background: PubMed 19616722Nava S, Hill N. Non-invasive ventilation in acute respiratory failure. Lancet. 2009 Jul 18;374(9685):250-9. doi: 10.1016/S0140-6736(09)60496-7.
- Background: PubMed 19615296Gray AJ, Goodacre S, Newby DE, Masson MA, Sampson F, Dixon S, Crane S, Elliott M, Nicholl J; 3CPO Study Investigators. A multicentre randomised controlled trial of the use of continuous positive airway pressure and non-invasive positive pressure ventilation in the early treatment of patients presenting to the emergency department with severe acute cardiogenic pulmonary oedema: the 3CPO trial. Health Technol Assess. 2009 Jul;13(33):1-106. doi: 10.3310/hta13330.
- Background: PubMed 17622735Glerant JC, Rose D, Oltean V, Dayen C, Mayeux I, Jounieaux V. Noninvasive ventilation using a mouthpiece in patients with chronic obstructive pulmonary disease and acute respiratory failure. Respiration. 2007;74(6):632-9. doi: 10.1159/000105163. Epub 2007 Jul 2.
- Background: PubMed 23542800Severgnini P, Selmo G, Lanza C, Chiesa A, Frigerio A, Bacuzzi A, Dionigi G, Novario R, Gregoretti C, de Abreu MG, Schultz MJ, Jaber S, Futier E, Chiaranda M, Pelosi P. Protective mechanical ventilation during general anesthesia for open abdominal surgery improves postoperative pulmonary function. Anesthesiology. 2013 Jun;118(6):1307-21. doi: 10.1097/ALN.0b013e31829102de.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Weifeng Yu, Ph.D. study chair
Department of Anesthesiology Renji Hospital, Shanghai Jiaotong University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laryngeal mask airway（LMA） and Endotracheal intubation（ETI） in people with Complications and Surgery, run by RenJi Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The occurrence of postoperative pulmonary complications (time frame: before discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02240901, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2020.