Obstructive Sleep Apnea, Sleep-disordered Breathing
Conditions
Keywords
Sleep-disordered breathing, Obstructive sleep apnea, Polysomnography, Tonsillectomy, Microdebrider assisted partial intracapsular tonsillectomy
Brief summary
The purpose of this study is to demonstrate similar improvements in sleep-disordered breathing as determined by sleep study with microdebrider-assisted partial intracapsular tonsillectomy and adenoidectomy versus total Bovie electrocautery tonsillectomy and adenoidectomy.
Detailed description
Objectives: To demonstrate similar improvement in sleep-disordered breathing as determined by polysomnography (PSG) with microdebrider-assisted partial intracapsular tonsillectomy and adenoidectomy (PITA) versus Bovie electrocautery complete tonsillectomy and adenoidectomy (T&A). Methods: In a retrospective cohort study children found to have Obstructive Sleep Apnea (OSA) by PSG who have undergone either PITA or T&A as treatment will be evaluated with repeat PSG. The groups will be matched by age, sex, and severity of pre-operative Apnea-Hypopnea Indices (AHI). The investigators performing and evaluating the PSG will be blinded to type of procedure and preoperative AHI. Change scores will be computed for each participant and the change scores of the groups compared.
Interventions
PROCEDUREPITA or T&A
PITA - Microdebrider-assisted Partial Intracapsular Tonsillectomy and Adenoidectomy T&A - Bove Electrocautery Complete Tonsillectomy and Adenoidectomy
Sponsors
American Society of Pediatric Otolaryngology
State University of New York - Downstate Medical Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
6 Months to 14 Years
Healthy volunteers
No
Inclusion criteria
* The medical records of 149 children who underwent partial intracapsular tonsillectomy and adenoidectomy at the State University of New York (SUNY) Downstate Medical Center or the Long Island College Hospital will be reviewed to identify children with positive preoperative polysomnography. 18 of those with positive preoperative studies will be randomly selected and offered participation in the study. * Once enrolled, the participants will be matched by age, sex, time since procedure and polysomnography results (Apnea Hypopnea Index Index within 5) to 18 children who underwent traditional tonsillectomy and adenoidectomy (out of a total of 455 patients).
Exclusion criteria
* Recurrent tonsillitis * Craniofacial syndromes * Neuromuscular disorders * Sickle cell disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Median Change in Apnea-hypopnea Index (AHI) | Baseline and 4 years | Change in the number of apneas plus hypopneas per hour of sleep on preoperative sleep study compared to postoperative sleep study, Change is calculated as baseline minus 4-year time point |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Apnea-hypopnea Index (AHI) Less Than or Equal to 5 | Baseline and 4 years | Number of patients with postoperative apnea-hypopnea index (apneas plus hypopneas per hour of sleep) less than or equal to 5 on sleep study |
Countries
United States
Participant flow
Recruitment details
Review of surgical case logs identified 45 patients with positive polysomnography (PSG) (laboratory-based, home or nap)who had undergone PITA and 101 with positive PSG who had undergone T&A.
Pre-assignment details
Of these 15 PITA patients entered and completed the study and 15 matched T&A patients entered and completed the study.
Participants by arm
| Arm | Count |
|---|---|
| Children Who Underwent PITA Children who underwent partial intracapsular tonsillectomy and adenoidectomy. | 15 |
| Children Who Underwent T&A Children who underwent total tonsillectomy and adenoidectomy. | 15 |
| Total | 30 |
Baseline characteristics
| Characteristic | Children Who Underwent T&A | Children Who Underwent PITA | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 15 Participants | 15 Participants | 30 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 6.15 years STANDARD_DEVIATION 3.29 | 5.33 years STANDARD_DEVIATION 3.65 | 5.74 years STANDARD_DEVIATION 3.44 |
| Region of Enrollment United States | 15 participants | 15 participants | 30 participants |
| Sex: Female, Male Female | 8 Participants | 3 Participants | 11 Participants |
| Sex: Female, Male Male | 7 Participants | 12 Participants | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 15 | 0 / 15 |
| serious Total, serious adverse events | 0 / 15 | 0 / 15 |
Outcome results
Primary
Median Change in Apnea-hypopnea Index (AHI)
Change in the number of apneas plus hypopneas per hour of sleep on preoperative sleep study compared to postoperative sleep study, Change is calculated as baseline minus 4-year time point
Time frame: Baseline and 4 years
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Children Who Underwent PITA | Median Change in Apnea-hypopnea Index (AHI) | 3.8 events per hour of sleep | Standard Deviation 8.5 |
| Children Who Underwent T&A | Median Change in Apnea-hypopnea Index (AHI) | 8.0 events per hour of sleep | Standard Deviation 18.7 |
Comparison: The relationship of surgical group with AHI change was evaluated by constructing a mixed linear model (MLM). The dependent variable was the logarithm of the ratio of postoperative AHI score to preoperative AHI score; this transformation was chosen in order to minimize skew of model residuals. Surgical group was introduced as a fixed factor; subject pairs constituted levels of a random blocking) factor.p-value: 0.59Mixed Models Analysis
Comparison: A mixed linear model was constructed as described above. Variance was estimated separately for each group.p-value: 0.022Mixed Models Analysis
Secondary
Number of Patients With Apnea-hypopnea Index (AHI) Less Than or Equal to 5
Number of patients with postoperative apnea-hypopnea index (apneas plus hypopneas per hour of sleep) less than or equal to 5 on sleep study
Time frame: Baseline and 4 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Children Who Underwent PITA | Number of Patients With Apnea-hypopnea Index (AHI) Less Than or Equal to 5 | 5 participants |
| Children Who Underwent T&A | Number of Patients With Apnea-hypopnea Index (AHI) Less Than or Equal to 5 | 4 participants |
Comparison: The relationship of surgical group with postoperative AHI ≤ 5 was evaluated by exact conditional logistic regression, predicting AHI ≤ 5 from surgical group with subject pairs as strata.p-value: 1Fisher Exact