Dataset Information

Comparison of a polyvinyl chloride tube with a wire-reinforced tube for tracheal intubation through the SaCoVLM video laryngeal mask airway: protocol for a randomised controlled study.

ABSTRACT:

Introduction

The SaCoVLM is a new type of video intubating laryngeal mask airway (LMA), and it is the first LMA to realise continuous visual monitoring. There is a lack of studies on intubation using the SaCoVLM. The aim of this study is to compare the success rate of intubation with polyvinyl chloride (PVC) tubes and wire-reinforced (WR) tubes using the SaCoVLM.

Methods and analysis

This prospective, single-centre, single-blind, parallel-arm, randomised controlled study will be conducted in a tertiary university hospital in China. We will include 104 patients undergoing elective laparoscopic surgery under general anaesthesia. Patients will be randomly assigned to the PVC tracheal tube group (n=52, PVC group) or the WR tracheal tube group (n=52, WR group). The primary outcome is the total success rate of intubation. The secondary outcomes are the first success rate of intubation, the time of tracheal intubation, the site of the first contact, the adjustment action for tracheal intubation, haemodynamic fluctuation during intubation and extubation, incidence of trauma as evidenced by blood, and the incidence rates of postoperative sore throat, hoarseness, and dysphagia.

Ethics and dissemination

This study was approved by the Ethics Committee of the First Affiliated Hospital of Shandong First Medical University (YXLL-KY-2022 (008)). All participants will provide written informed consent. The results will be disseminated through peer-reviewed publications and at conferences or congresses.

Trial registration number

NCT05338827.

SUBMITTER: Gao Z

PROVIDER: S-EPMC9756190 | biostudies-literature | 2022 Dec

REPOSITORIES: biostudies-literature

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Publications

Comparison of a polyvinyl chloride tube with a wire-reinforced tube for tracheal intubation through the SaCoVLM video laryngeal mask airway: protocol for a randomised controlled study.

Gao Zhongquan Z Guo Yongle Y Gao Xiaojun X Wang Weiwei W Zhang Min M Liu Meng Jie MJ Chen Lina L Liu Yang Y Zhang Xiaoning X Sun Yongtao Y Wang Yuelan Y

BMJ open 20221214 12

<h4>Introduction</h4>The SaCoVLM is a new type of video intubating laryngeal mask airway (LMA), and it is the first LMA to realise continuous visual monitoring. There is a lack of studies on intubation using the SaCoVLM. The aim of this study is to compare the success rate of intubation with polyvinyl chloride (PVC) tubes and wire-reinforced (WR) tubes using the SaCoVLM.<h4>Methods and analysis</h4>This prospective, single-centre, single-blind, parallel-arm, randomised controlled study will be c ...[more]

PMID: 36517088

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Project description:BackgroundHypoxemia is the most common complication during tracheal intubation of critically ill adults and may increase the risk of cardiac arrest and death. Whether positive-pressure ventilation with a bag-mask device (bag-mask ventilation) during tracheal intubation of critically ill adults prevents hypoxemia without increasing the risk of aspiration remains controversial.MethodsIn a multicenter, randomized trial conducted in seven intensive care units in the United States, we randomly assigned adults undergoing tracheal intubation to receive either ventilation with a bag-mask device or no ventilation between induction and laryngoscopy. The primary outcome was the lowest oxygen saturation observed during the interval between induction and 2 minutes after tracheal intubation. The secondary outcome was the incidence of severe hypoxemia, defined as an oxygen saturation of less than 80%.ResultsAmong the 401 patients enrolled, the median lowest oxygen saturation was 96% (interquartile range, 87 to 99) in the bag-mask ventilation group and 93% (interquartile range, 81 to 99) in the no-ventilation group (P = 0.01). A total of 21 patients (10.9%) in the bag-mask ventilation group had severe hypoxemia, as compared with 45 patients (22.8%) in the no-ventilation group (relative risk, 0.48; 95% confidence interval [CI], 0.30 to 0.77). Operator-reported aspiration occurred during 2.5% of intubations in the bag-mask ventilation group and during 4.0% in the no-ventilation group (P = 0.41). The incidence of new opacity on chest radiography in the 48 hours after tracheal intubation was 16.4% and 14.8%, respectively (P = 0.73).ConclusionsAmong critically ill adults undergoing tracheal intubation, patients receiving bag-mask ventilation had higher oxygen saturations and a lower incidence of severe hypoxemia than those receiving no ventilation. (Funded by Vanderbilt Institute for Clinical and Translational Research and others; PreVent ClinicalTrials.gov number, NCT03026322.).

Project description:BackgroundSeveral studies have identified side effects of general anesthesia with endotracheal intubation, such as laryngeal pain, dysphonia, and postoperative nausea and vomiting (PONV). The laryngeal mask airway (LMAw) is believed to decrease these side effects. The aim of this trial was to compare postoperative discomfort, emergence delirium, and recovery time of patients who received either an LMAw or nasotracheal intubation (NTI).Patients and methodsA total of 70 children were randomly assigned to the LMAw group (n=35) or the NTI group (n=35). Both groups underwent mask induction with 8% sevoflurane. The NTI group received muscle relaxant, whereas the LMAw group did not. Postoperative laryngeal pain, dental pain, dysphonia, and PONV were assessed immediately and at 1 hour and 6 hours postoperatively. The Wong-Baker Faces Scale was used to evaluate the patients' self-reported pain. In addition, decayed, missing, and filled teeth (dft/DMFT) values, dental procedure type, number of dental procedures, duration of the dental operation, duration of anesthesia, recovery time, emergence delirium, pediatric dentist's access to the mouth, and parents' satisfaction levels were recorded. Data were analyzed using descriptive statistics, chi-square tests, and two-sample t-tests.ResultsThe incidence of postoperative laryngeal pain was significantly higher in the NTI group immediately (97.2% vs. 8.5%, P=0.00), 1 hour (94.2% vs. 0%, P=0.00), and 6 hours postoperatively (25.7% vs. 0%, P=0.00). There were no statistically significant differences between the two groups in dental pain scores, dft/DMFT values, duration of anesthesia, duration of the dental operation, number of dental procedures, the incidence of PONV, or pediatric dentist's access to the mouth (P>0.05). Emergence delirium and recovery time were significantly higher in the NTI group (P<0.05).ConclusionThe LMAw provided a more comfortable postoperative period than NTI for children who underwent full-mouth dental rehabilitation under general anesthesia.

Dataset Information

Comparison of a polyvinyl chloride tube with a wire-reinforced tube for tracheal intubation through the SaCoVLM video laryngeal mask airway: protocol for a randomised controlled study.

Introduction

Methods and analysis

Ethics and dissemination

Trial registration number

Publications

Comparison of a polyvinyl chloride tube with a wire-reinforced tube for tracheal intubation through the SaCoVLM video laryngeal mask airway: protocol for a randomised controlled study.

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