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Manual Valsalva Maneuver As a Preventive Measure of Postoperative Laryngospasm in Laryngomalacia Cases Undergoing Supraglottoplasty

Manual Valsalva Maneuver As a Preventive Measure of Postoperative Laryngospasm in Laryngomalacia Cases Undergoing Supraglottoplasty

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06627660
Enrollment
58
Registered
2024-10-04
Start date
2024-10-06
Completion date
2025-02-01
Last updated
2024-10-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Laryngomalacia, Laryngospasm

Keywords

VALSALVA MANEUVER, Postoperative Laryngospasm, Supraglottoplasty

Brief summary

We hypothesized that manual valsalva maneuver prevent incidence of postoperative laryngospasm after supraglottoplasty for cases of congenital laryngomalacia. Primary outcome: Incidence of postoperative stridor and laryngospasm Secondary outcome: incidence of reintubation, postoperative hemodynamics, duration of postoperative ICU and hospital stay

Detailed description

Congenital Laryngomalacia is the main cause of stridor in newborns and infants, affecting 45-75% of all infants with congenital stridor. Short aryepiglottic folds, redundant arytenoid, omega-shaped epiglottis, and inspiratory stridor are features of laryngomalacia. Pediatric laryngospasm is a glottic closure due to reflex constriction of the laryngeal muscles that produce partial or complete obstruction of the larynx. When complete and sustained, laryngospasm is considered an anesthetic Emergency. The valsalva maneuver involves expiratory effort against a closed glottis in the sitting or supine position with the intraoral and intrathoracic pressures raised to 40 mmHg for 15-20 sec, after which the pressure is suddenly released and the breathing restored to normal. We hypothesized that manual valsalva maneuver prevent incidence of postoperative laryngospasm after supraglottoplasty for cases of congenital laryngomalacia. After approval of IRB, Mansoura University, this study will be conducted on infants and children ASA I or II aging from 1 month age- 6 years undergoing supraglottoplasty in Mansoura university hospitals. After obtaining a written informed consent from patients parents, random number generator with closed envelope technique will randomize patients into two groups \[control\] group ( C group ), Valsalva group ( V group)\]. Anesthesia will be induced by inhalational induction using sevoflurane at concentration (6:8%). After that, a proper sized cannula will be introduced with giving atropine 0,01mg/kg and hydrocortisone 4mg/ kg. Then, patients will be seen by fiberoptic endoscopy by the surgeon to detect the stage of laryngomalacia and the supraglottic pathology. After that, proper sized ETT will be inserted using succinylcholine 1mg\\kg IV and fixed in place after confirmation of correct positioning , with maintenance of anesthesia with isoflurane. All patients will be given 0.5-1mic /kg fentanyl and 15 mg /kg paracetamol. A pilot study will be done including 5 patients in each study group. The Incidence of postoperative stridor will be used as the primary variable with difference between studied groups was 40% (50% in group C versus 10% in group V). G\*power software version 3.1.9.2 will be utilized to detect the required sample size for a study power of 90% and alpha error of 0.05. Cases involved in the pilot study will not be included in the total sample size of the study. Then total sample size will be 26 in each group and by adding 10% to compensate for possible drop out then total sample size per group will be 29 cases in each group. Perioperative data will be tabulated and analyzed using IBM SPSS software version 26.

Interventions

Closure of the nose and mouth during expiration for 20 sec

Sponsors

Sameh Fathy
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)

Intervention model description

INTERVENTIONAL

Eligibility

Sex/Gender
ALL
Age
1 Months to 6 Years
Healthy volunteers
Yes

Inclusion criteria

* Infants and children ASA I or II aging from 1 month age - 6 years undergoing supraglottoplasty

Exclusion criteria

* Parents refusal. * Patients with increased ICP * Patients with increased IOP

Design outcomes

Primary

MeasureTime frame
Incidence of laryngospasm24 HOURS

Secondary

MeasureTime frameDescription
incidence of reintubation24 HOURS
Postoperative oxygen saturation measurement1 HOUROxygen saturation (%) is recorded every 5 minutes
Incidence of postoperative nausea and vomiting24 HOURS
Duration of postoperative hospital stay24 HOURS

Contacts

Primary ContactSAMEH FATHY ELSHERBINY, DOCTORAL DEGREE (MD)
SMFSHERBINY@YAHOO.COM002-0100-6500748

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026