阻塞性睡眠呼吸暂停气道正压与手动调节临床指南【美国2008】

Journal of Clinical Sleep Medicine, Vol. 4, No. 2, 2008 157 Summary: Positive airway pressure (PAP) devices are used to treat patients with sleep related breathing disorders (SRBDs), including obstructive sleep apnea (OSA). After a patient is diagnosed with OSA, the current standard of practice involves performing attended polysomnography (PSG), during which positive airway pressure is adjusted throughout the recording period to determine the optimal pressure for maintaining upper airway patency. Continuous positive airway pressure (CPAP) and bilevel positive airway pressure (BPAP) represent the two forms of PAP that are manually titrated during PSG to determine the single fixed pressure of CPAP or the fixed inspiratory and expiratory positive airway pressures (IPAP and EPAP, respec- tively) of BPAP for subsequent nightly usage. A PAP Titration Task Force of the American Academy of Sleep Medicine reviewed the avail- able literature. Based on this review, the Task Force developed these recommendations for conducting CPAP and BPAP titrations. Major recommendations are as follows: (1) All potential PAP titration candi- dates should receive adequate PAP education, hands-on demonstra- tion, careful mask fitting, and acclimatization prior to titration. (2) CPAP (IPAP and/or EPAP for patients on BPAP) should be increased until the following obstructive respiratory events are eliminated (no spe- cific order) or the recommended maximum CPAP (IPAP for patients on BPAP) is reached: apneas, hypopneas, respiratory effort-related arousals (RERAs), and snoring. (3) The recommended minimum start- ing CPAP should be 4 cm H2O for pediatric and adult patients, and the recommended minimum starting IPAP and EPAP should be 8 cm H2O and 4 cm H2O, respectively, for pediatric and adult patients on Clinical Guidelines for the Manual Titration of Positive Airway Pressure in Patients with Obstructive Sleep Apnea Positive Airway Pressure Titration Task Force of the American Academy of Sleep Medicine Task Force Members: Clete A. Kushida, M.D., Ph.D., RPSGT (Chair)1; Alejandro Chediak, M.D. (Vice-Chair)2; Richard B. Berry, M.D.3; Lee K. Brown, M.D.4; David Gozal, M.D.5; Conrad Iber, M.D.6; Sairam Parthasarathy, M.D.7; Stuart F. Quan, M.D.8; James A. Rowley, M.D.9 1Stanford University Center of Excellence for Sleep Disorders, Stanford, CA; 2Sleep Disorders Center, Mount Sinai Medical Center, Miami Beach, FL; 3Division of Pulmonary, Critical Care, and Sleep Medicine, University of Florida, Gainesville, FL; 4University of New Mexico Health Sciences Center, Albuquerque, NM; 5Department of Pediatrics, Division of Pediatric Sleep Medicine, University of Louisville, Louisville, KY; 6University of Minnesota, Minneapolis, MN; 7SAVAHCS and University of Arizona, Tucson, AZ; 8Division of Sleep Medicine, Harvard Medical School, Boston, MA; 9Department of Internal Medicine, Division of Pulmonary, Allergy, Critical Care & Sleep Medicine, Wayne State University School of Medicine, Detroit, MI Disclosure Statement This was not an industry supported study. The authors have indicated no financial conflicts of interest. Submitted for publication February, 2008 Accepted for publication February, 2008 Address correspondence to: Clete A. Kushida, MD, PhD, RPSGT, Stan- ford University Center of Excellence for Sleep Disorders, 401 Quarry Road, Suite 3301, Stanford, CA, 94305-5730 SpeciAl Article BPAP. (4) The recommended maximum CPAP should be 15 cm H2O (or recommended maximum IPAP of 20 cm H2O if on BPAP) for pa- tients <12 years, and 20 cm H2O (or recommended maximum IPAP of 30 cm H2O if on BPAP) for patients ≥12 years. (5) The recommended minimum IPAP-EPAP differential is 4 cm H2O and the recommended maximum IPAP-EPAP differential is 10 cm H2O (6) CPAP (IPAP and/or EPAP for patients on BPAP depending on the type of event) should be increased by at least 1 cm H2O with an interval no shorter than 5 min, with the goal of eliminating obstructive respiratory events. (7) CPAP (IPAP and EPAP for patients on BPAP) should be increased from any CPAP (or IPAP) level if at least 1 obstructive apnea is observed for patients <12 years, or if at least 2 obstructive apneas are observed for patients ≥12 years. (8) CPAP (IPAP for patients on BPAP) should be increased from any CPAP (or IPAP) level if at least 1 hypopnea is ob- served for patients <12 years, or if at least 3 hypopneas are observed for patients ≥12 years. (9) CPAP (IPAP for patients on BPAP) should be increased from any CPAP (or IPAP) level if at least 3 RERAs are observed for patients <12 years, or if at least 5 RERAs are observed for patients ≥12 years. (10) CPAP (IPAP for patients on BPAP) may be increased from any CPAP (or IPAP) level if at least 1 min of loud or unambiguous snoring is observed for patients <12 years, or if at least 3 min of loud or unambiguous snoring are observed for patients ≥12 years. (11) The titration algorithm for split-night CPAP or BPAP titration studies should be identical to that of full-night CPAP or BPAP titration studies, respectively. (12) If the patient is uncomfortable or intolerant of high pressures on CPAP, the patient may be tried on BPAP. If there are continued obstructive respiratory events at 15 cm H2O of CPAP during the titration study, the patient may be switched to BPAP. (13) The pressure of CPAP or BPAP selected for patient use following the titration study should reflect control of the patient’s obstructive respira- tion by a low (preferably <5 per hour) respiratory disturbance index (RDI) at the selected pressure, a minimum sea level SpO2 above 90% at the pressure, and with a leak within acceptable parameters at the pressure. (14) An optimal titration reduces RDI <5 for at least a 15- min duration and should include supine REM sleep at the selected pressure that is not continually interrupted by spontaneous arousals Journal of Clinical Sleep Medicine, Vol. 4, No. 2, 2008 158 CA Kushida, A Chediak, RB Berry et al 1.0 iNtrODUctiON Positive airway pressure (PAP) is a standard treatment for patients with obstructive sleep apnea (OSA), a sleep related breathing disorder characterized by full or partial occlusion of the upper airway during sleep. Standard sleep medicine practice involves manual pressure adjustment by a sleep technologist during attended laboratory polysomnography (PSG) to elimi- nate obstructive respiratory-related events (apneas, hypopneas, respiratory effort-related arousals [RERAs], and snoring). A PAP delivery system consists of three main components: a PAP device; a nasal, oral, or oronasal interface (i.e., nasal mask, na- sal pillows, full-face mask) held snug to the face by headgear; and a flexible hose that connects the device to the interface. A PAP device is basically an air pump (fan-driven or turbine system) that draws in external, filtered air and delivers pressur- ized airflow, which is adjustable by varying the pressure valve diameter or fan/turbine speed. PAP devices are divided into four basic types depending on their pressure delivery system: (1) continuous positive airway pressure (CPAP), which delivers a single, fixed pressure to the patient during the night; (2) bi- level positive airway pressure (BPAP), which delivers a higher inspiratory PAP (IPAP) than expiratory PAP (EPAP); (3) auto- titrating positive airway pressure (APAP), which automatically increases CPAP or BPAP (IPAP/EPAP) as needed to maintain airway patency and then decreases the pressure if no abnormal respiratory events are detected within a set period of time; and (4) adaptive servoventilation (ASV), which uses a servocon- troller that automatically adjusts pressure by breath-by-breath analysis to maintain a steady minute ventilation especially in heart failure patients with central sleep apnea and/or Cheyne- Stokes respiration. A 2004 national survey of 196 board certified sleep physi- cians regarding APAP device prescriptions based upon point- prevalence estimates revealed that only 4% of PAP devices prescribed were APAP and that 30% of board certified sleep physicians reported having never prescribed APAP devices.1 As more validation and reliability studies in diverse settings are being conducted, it is assumed that sleep medicine specialists are gradually becoming more accepting of the use of APAP devices.2-4 Nevertheless, manual titration of CPAP or BPAP is currently the gold standard for selection of the optimal (effec- tive) pressure for CPAP and BPAP (IPAP/EPAP), respectively, and the goal of this report was to develop recommendations that reflect current knowledge and practice of this procedure. The American Academy of Sleep Medicine (AASM) has published practice parameters on the indications for PSG5,6 (i.e., the utility of PSG for the diagnosis of sleep-related breathing disorders) and on the indications for CPAP and BPAP in the treatment of airway obstruction in OSA.7 Lastly, in 2007, the AASM published a new scoring manual that defines the abnor- mal respiratory events (e.g., apneas, hypopneas, RERAs), which are used for PAP titration.8 The present recommendations add to but do not modify any of these previously published guidelines and definitions. 2.0 MetHODS The AASM Board of Directors approved the development of PAP titration recommendations in April 2007, and approved the appointments of Task Force members in July 2007. An ini- tial literature search was conducted by Drs. Alejandro Chediak and Vincenzo Novara on November 27, 2006 using the key words: CPAP initiation, CPAP titration, CPAP adjustment, PAP titration, bilevel positive pressure titration, bi-level pressure titration, BiPAP titration, and BiPAP adjustment. This search yielded 372 results, of which 26 relevant abstracts and articles were obtained and reviewed. Supplemental literature searches were conducted on June 29, 2007 and December 5, 2007 us- ing the same key words as in the original search; an additional literature search was conducted on November 30, 2007 using the same key words plus the key word: children. These sup- plemental searches yielded an additional 82 results, of which 7 additional relevant articles were obtained and reviewed. All literature searches were computer-based using PubMed. The objective was to identify all studies that described PAP titration protocols and that were published in English from 1968 up to the date of the searches. Twenty-two additional relevant publi- cations were obtained after reviewing the bibliographies of the publications collected through the original and supplemental searches. Lastly, the Task Force also reviewed PAP titration protocols developed by industry for background information; however, these protocols were not used to support the recom- mendations. All relevant publications were assigned an evidence level based on the classification shown in Table 1. Potential recommendations reflected evidence for reliability and validity as assessed by the Task Force following literature review, or comprised uncertainties in the literature that needed resolution by consensus. The Rand/UCLA Appropriateness Method10 was selected as the consensus process for use by the Task Force given its use by the AASM Standards of Practice Committee (SPC) and the AASM Scoring Manual Task Forces, and also because the relative paucity of evidence warranted or awakenings. (15) A good titration reduces RDI ≤10 or by 50% if the baseline RDI <15 and should include supine REM sleep that is not continually interrupted by spontaneous arousals or awakenings at the selected pressure. (16) An adequate titration does not reduce the RDI ≤10 but reduces the RDI by 75% from baseline (especially in severe OSA patients), or one in which the titration grading criteria for optimal or good are met with the exception that supine REM sleep did not oc- cur at the selected pressure. (17) An unacceptable titration is one that does not meet any one of the above grades. (18) A repeat PAP titration study should be considered if the initial titration does not achieve a grade of optimal or good and, if it is a split-night PSG study, it fails to meet AASM criteria (i.e., titration duration should be >3 hr). Keywords: PAP; titration; continuous positive airway pressure; CPAP; bilevel positive airway pressure; BPAP; obstructive sleep apnea; sleep related breathing disorder; sleep disordered breathing citation: Kushida CA; Chediak A; Berry RB; Brown LK; Gozal D; Iber C; Parthasarathy S; Quan SF; Rowley JA; Positive Airway Pres- sure Titration Task Force of the American Academy of Sleep Medi- cine. Clinical guidelines for the manual titration of positive airway pressure in patients with obstructive sleep apnea. J Clin Sleep Med 2008;4(2):157-171. Journal of Clinical Sleep Medicine, Vol. 4, No. 2, 2008 159 Manual Titration of Positive Airway Pressure a formal consensus process. The first conference call of the Task Force was held on July 23, 2007 to discuss the consensus process and to develop a ballot comprised of possible recom- mendations. In order to encourage single recommendations, the ballots were constructed when possible to address mutu- ally exclusive options. For balloting, the possible recommenda- tions were rated on a 9-point scale for appropriateness and a 4-letter rank for specifying a judgment regarding whether the decision was being made on evidence vs. opinion. The “classic” definition of agreement was assessed using definitions from the RAND manual: Agreement for or against: No more than 2 Task Force mem-• bers rate the indication outside the 3-point region (1-3, 4-6, 7-9) containing the median. Disagreement: At least 3 Task Force members rate the indi-• cation in the 1-3 region, and at least 3 Task Force members rate it in the 7-9 region. Indeterminate: Criteria are not met for agreement or dis-• agreement. The first round ballot was distributed to the Task Force on August 6, 2007 and was completed by September 1, 2007; Task Force members completed this round of voting individually without discussion. The first round ballot results were distrib- uted to the Task Force on September 14, 2007. A conference call for the second round of voting was held on September 24, 2007, at which time there was discussion of the recommenda- tions and the results of the first vote; consensus was achieved on all recommendations during this second round of voting. The recommendations in section 4.0 were developed based on the voting results and were subsequently reviewed by two out- side reviewers, the Chair of the AASM Standards of Practice Committee, and the AASM Board of Directors. The Executive Committee of the AASM Board of Directors approved these recommendations on February 8, 2008. All members of the Task Force and the Board of Directors completed detailed conflict-of-interest statements; none had Level 1 conflicts in the scope of their roles. Most participants in the development of this report are directors or members of sleep disorders centers, and many have substantial experience with PAP titration. These recommendations should not be con- sidered inclusive of all proper methods of care or exclusive of other methods of care reasonably directed to obtaining the same results. The ultimate judgment regarding the propriety of any specific care must be made by the clinician in light of the indi- vidual circumstances presented by the patient and the availabil- ity of diagnostic and treatment options and resources. The AASM expects these recommendations to have a positive impact upon the practice of sleep medicine, patient treatment outcomes, and health care costs. These recommendations re- flect the state of knowledge at publication and will be reviewed, updated, and revised as new information becomes available. It is important to note that the recommendations published in this report are not practice parameters, since the majority of these recommendations do not achieve the evidence level of typical practice parameters. Instead, all recommendations were devel- oped using the consensus process and the evidence grading was used only to indicate the level of evidence available to sup- port the recommendations. AASM levels of recommendations (Table 2) are indicated in parentheses after recommendations that are based on published practice parameters; those recom- mendations that were not based on published parameters are labeled as “(Consensus).” 3.0 BAcKGrOUND The manual titration of positive airway pressure has been conducted for over a quarter of a century,12 yet no standard- ized protocols exist for this procedure.13 A survey of accredited sleep centers reviewed titration protocols from 51 accredited centers and found that the procedures described for PAP titra- tion varied widely among the centers; 22% of these centers did not have a written protocol.14 The lack of standardization re- sults in clinicians and technologists from different sleep labo- ratories developing their own protocols15 or relying on proto- cols obtained from industry or other sleep laboratories. When a standardized protocol is implemented, the optimal pressure for CPAP can be reproducible; one study revealed a Spearman cor- relation coefficient of 0.89 for the optimal pressure selected for 2 consecutive CPAP titration nights in 50 patients with OSA.16 Table 1—AASM Classification of Evidence Evidence Levels Study Design I Randomized well-designed trials with low alpha and beta error* II Randomized trials with high alpha and beta error* III Nonrandomized concurrently controlled studies IV Nonrandomized historically controlled studies V Case series Adapted from Sackett9 *Alpha error refers to the probability (generally set at 95% or greater) that a significant outcome (e.g., p < 0.05) is not a result of chance occurrence. Beta error refers to the probability (generally set at 80% to 90% or greater) that a nonsignificant result (e.g., p > 0.05) is the correct conclusion of the study or studies. The estima- tion of beta error is generally the result of a power analysis. The power analysis includes a sample size analysis to project the size of the study population necessary to ensure that significant differ- ences will be observed if actually present. Table 2—AASM Levels of Recommendations Term Definition Standard This is a generally accepted patient care strategy that reflects a high degree of clinical certainty. The term standard generally implies the use of level I evidence that directly addresses the clini- cal issue, or overwhelming level II evidence. Guideline This is a patient care strategy that reflects a moderate degree of clinical certainty. The term guideline implies the use of level II evidence or a consensus of level III evidence. Option Recommendation with less evidence than guideline for which agreement was reached in a standardized consensus process based on avail- able information. Adapted from Eddy11 and Iber et al.8 Journal of Clinical Sleep Medicine, Vol. 4, No. 2, 2008 160 (SRBDs). Other SRBDs are not addressed except when relevant to adaptive servoventilation treatment. The respiratory distur- bance index (RDI) refers to the total of apneas, hypopneas, and RERAs per hour of sleep, and for this report, this term is not synonymous with the AHI, which refers to the total of apneas and hypopneas per hour of sleep. Mild, moderate and severe OSA are defined according to following criteria in adults: mild, RDI 5 to ≤15; moderate, RDI 15 to 30; and severe, RDI >30.31 In children <12 years of age: mild, RDI 1 to <5; moderate, RDI 5 to <10; and severe, RDI >10.8,32-34 4.0 recOMMeNDAtiONS The following are recommendations of the PAP Titration Task Force and the AASM Board of Directors. The scope of these PAP titration recommendations is restricted