Status Approved
First Submitted Date
2012/01/25
Registered Date
2012/02/01
Last Updated Date
2012/01/30
CRIS Required
WHO ICTRP (International Clinical Trial Registry Platform) Required
1. Background
| CRIS Registration Number |
KCT0000334 |
|---|---|
| Unique Protocol ID | KUH1160036 |
| Public/Brief Title | Incidence of postoperative pharyngolaryngeal adverse events with LMA Supreme at high and low intracuff pressures |
| Scientific Title | Incidence of postoperative pharyngolaryngeal adverse events with LMA Supreme at high and low intracuff pressures |
| Acronym | |
| MFDS Regulated Study | No |
| IND/IDE Protocol | No |
| Registered at Other Registry | No |
| Healthcare Benefit Approval Status |
2. Institutional Review Board / Ethics Committee
| Board Approval Status | Submitted approval |
|---|---|
| Board Approval Number | KUH1160036 |
| Approval Date | 2011-12-08 |
| Institutional Review Board Name | konkuk university medical center institutional review board |
| Institutional Review Board Address | |
| Institutional Review Board Telephone | |
| Data Monitoring Committee |
3. Contact Details
| Contact Person for Principal Investigator / Scientific Queries | |
|---|---|
| Name | Seong-hyop Kim |
| Title | MD, PhD |
| Telephone | |
| Affiliation | Konkuk University |
| Address | |
| Contact Person for Public Queries | |
| Name | Jooeun Kang |
| Title | MD |
| Telephone | |
| Affiliation | Konkuk University |
| Address | |
| Contact Person for Updating Information | |
| Name | Jooeun Kang |
| Title | MD |
| Telephone | |
| Affiliation | Konkuk University |
| Address | |
4. Status
| Study Site | Single | |
|---|---|---|
| Overall Recruitment Status | Recruiting | |
| Date of First Enrollment | 2012-01-03 Actual | |
| Target Number of Participant | 120 | |
| Primary Completion Date | 2012-12-31 , Anticipated | |
| Study Completion Date | ||
| Recruitment Status by Participating Study Site 1 | ||
| Name of Study | Konkuk University | |
| Recruitment Status | Recruiting | |
| Date of First Enrollment | 2012-01-03 , | |
5. Source of Monetary / Material Support
| 1. Source of Monetary/Material Support | |
|---|---|
| Organization Name | Konkuk University |
| Organization Type | Medical Institute |
| Project ID | KUH1160036 |
6. Sponsor Organization
| 1. Sponsor Organization | |
|---|---|
| Organization Name | Konkuk University |
| Organization Type | Medical Institute |
7. Study Summary
| Lay Summary | The aim of the study was to compare the postoperative pharyngeal adverse events between the cuff pressure of LMA below 25 cmH2O and at 60 cmH2O, and investigated the safety and efficacy of cuff pressure below 25 cmH2O in laparoscopic surgical procedures. The use of LMA size and the attempt number were recorded. If LMA insertion failure occurred, the causes of LMA insertion failure were recorded. The volume and pressure for LMA cuff inflation, and OLP were recorded just after anesthesia induction. Postoperative pharyngolaryngeal adverse events were assessed with predetermined definition: sore throat was defined as “constant pain or discomfort in the throat independent of swallowing”; dysphonia was defined as “difficult speaking or pain on speaking”; dysphagia was defined as “difficulty or pain provoked by swallowing”. The incidence of postoperative pharyngolaryngeal adverse events was recorded at discharge from PACU (T1) and 24 hours after discharge from PACU (T2). Any complications related with LMA insertion, such as recurrent laryngeal nerve palsy, hypoglossal nerve palsy, lingual nerve palsy, artenoid cartilage dislocation and so on, were also recorded at T1 and T2. Patient’s satisfaction scale for airway was assessed with visual analogue scale (VAS with -50~+50: 0, state before anesthesia; -50: very discomfort, compared with state before anesthesia; +50: very comfort, compared with state before anesthesia) at T1 and T2. Postoperative nausea and vomiting (PONV) was assessed using a three point ordinal scale (0=none, 1=nausea, 2=retching, 3=vomiting) at T1 and T2. Nausea was defined as a subjectively unpleasant sensation associated with awareness of the urge to vomiting. Retching was defined as the labored, spasmodic, rhythmic contraction of the respiratory muscles without the expulsion of gastric contents. Vomiting was defined as the forceful expulsion of gastric contents from the mouth. The severity of PONV was evaluated using a modified Rhodes index at T2. |
|---|
8. Study Design
| Study Type | Observational Study |
|---|---|
| Observational Study Model | Cohort |
| Time Perspective | Prospective |
| Target Number of Participant | 120 |
| Cohort/Group Number | 2 |
|
Cohort/ Group 1 |
Cohort/Group Label high pressure group |
|
Cohort/Group Description the cuff pressure of LMA Supreme is maintained as 60cmH2O. Postoperative pharyngolaryngeal adverse events were assessed with sore throat, dysphonia, dysphagia, postoperative pharyngolaryngeal adverse events was recorded at discharge from PACU (T1) and 24 hours after discharge from PACU (T2). Patient’s satisfaction scale for airway was assessed with visual analogue scale (VAS with -50~+50: 0, state before anesthesia; -50: very discomfort, compared with state before anesthesia; +50: very comfort, compared with state before anesthesia) at T1 and T2. Postoperative nausea and vomiting (PONV) was assessed using a three point ordinal scale (0=none, 1=nausea, 2=retching, 3=vomiting) at T1 and T2. |
|
|
Cohort/ Group 2 |
Cohort/Group Label low pressure group |
|
Cohort/Group Description The cuff pressure of LMA Supreme is maintained as below 25cmH2O. Postoperative pharyngolaryngeal adverse events were assessed with sore throat, dysphonia, dysphagia, postoperative pharyngolaryngeal adverse events was recorded at discharge from PACU (T1) and 24 hours after discharge from PACU (T2). Patient’s satisfaction scale for airway was assessed with visual analogue scale (VAS with -50~+50: 0, state before anesthesia; -50: very discomfort, compared with state before anesthesia; +50: very comfort, compared with state before anesthesia) at T1 and T2. Postoperative nausea and vomiting (PONV) was assessed using a three point ordinal scale (0=none, 1=nausea, 2=retching, 3=vomiting) at T1 and T2. |
|
| Biospecimen Collection & Archiving |
Not collect nor Archive |
| Biospecimen Description |
9. Subject Eligibility
| Study Population Description | Patients undergoing laparoscopic surgical procedures were enrolled |
|---|---|
| Sampling Method | simple random sampling |
| Condition(s)/Problem(s) |
* (S00-T98)Injury, poisoning and certain other consequences of external causes (T81.8)Other complications of procedures, NEC |
| Rare Disease | No |
| Inclusion Criteria |
Gender Both |
|
Age No Limit~No Limit |
|
|
Description Patients undergoing laparoscopic surgical procedures were enrolled and written informed consent was obtained. |
|
| Exclusion Criteria |
Patients were excluded if the following criteria present: 1)known or predicted difficult airway, 2)vocal cord paralysis, 3)recent history of respiratory infection (within 1 month), 4)neurological deficits or psychiatric disorders, 5)history of drug abuse, 6)receiving current medications, 7)allergy to egg or soybean oil, 8)contraindications for use of LMA. |
| Healthy Volunteers | No |
10. Outcome Measure(s)
| Type of Primary Outcome | /Safety/Efficacy | |
|---|---|---|
| Primary Outcome(s) 1 | ||
| Outcome | sore throat |
|
| Timepoint | discharge from PACU(T1), 24hours after discharge from PACU(T2) |
|
| Secondary Outcome(s) 1 | ||
| Outcome | dysphagia |
|
| Timepoint | discharge from PACU(T1), 24hours after discharge from PACU(T2) |
|
| Secondary Outcome(s) 2 | ||
| Outcome | dysphonia |
|
| Timepoint | discharge from PACU(T1), 24hours after discharge from PACU(T2) |
|
11. Study Results and Publication
| Result Registered |
|---|
12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
| Sharing Statement | Not provided at time of Registration |
|---|
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